Bruce Jancin

PRAGUE – Recognizing the slim chances of a direct comparison study of two biologics for treatment of psoriasis, Dr. Kristian Reich and his coworkers have done the next best thing: they’ve conducted an indirect comparison study.

They used existing data from four randomized trials to compare two biologics adalimumab (Humira) and etanercept (Enbrel) and adjusted for between-trial differences in baseline patient demographics, treatment history, and numerous measures of psoriasis severity.

The analysis was supported by Abbott, the maker of adalimumab. The drug had a significantly better benefit-risk profile as measured by the number of days patients spent with at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores while also remaining free of study drug–related adverse events, Dr. Reich reported at the annual congress of the European Academy of Dermatology and Venereology.

The four phase III, double-blind, randomized, placebo-controlled, 12-week clinical trials included REVEAL (J. Am. Acad. Dermatol. 2008;56:106-15) and CHAMPION (Br. J. Dermatol. 2008;158:558-66), studies that pitted adalimumab against placebo in 1,302 subjects. The analysis also included the M10-114 and M10-315 trials, which included 390 patients randomized to briakinumab (Abbott), etanercept, or placebo.

Prior to propensity score weighting, participants in the adalimumab studies differed from those in the etanercept trials in terms of disease duration, percent body surface area involvement, extent of prior medication use, PASI scores, and other important variables. After matching, however, the two groups were closely similar across the board, explained Dr. Reich of the Hamburg (Germany) Dermatology Clinic.

Through 12 weeks of study participation, adalimumab-treated patients spent an average of 22.4 more days at PASI 75 with no study drug–related side effects than did those on placebo in the same two studies. In contrast, etanercept-treated patients spent 11.5 more days than did controls in this optimal state.

At week 4, the proportion of biologic-treated subjects who were PASI 75 responders free of moderate-to-severe study drug–related adverse events was 15.7% in the adalimumab group compared with 5.5% with etanercept. At week 8, these rates climbed to 46.3% in the adalimumab-treated patients and 16.2% in the etanercept group. By week 12, the figures were 58% for adalimumab compared with 39.4% with etanercept.

An obvious limitation of this indirect comparison is the potential for confounding due to unobserved baseline differences. But Dr. Reich said he and his coinvestigators adjusted and balanced for everything they could think of.

"To further adjust for potential differences between trials, outcomes were compared relative to the corresponding placebo arms after applying propensity weights and before comparing across trials. Thus, unobserved factors that equally impact outcomes on the drug and placebo arms would not bias this comparison of adalimumab and etanercept," the dermatologist said.

Dr. Reich has received research grants from and serves as a consultant to Abbott, which supported this analysis, as well as to numerous other pharmaceutical companies.

PRAGUE – Recognizing the slim chances of a direct comparison study of two biologics for treatment of psoriasis, Dr. Kristian Reich and his coworkers have done the next best thing: they’ve conducted an indirect comparison study.

They used existing data from four randomized trials to compare two biologics adalimumab (Humira) and etanercept (Enbrel) and adjusted for between-trial differences in baseline patient demographics, treatment history, and numerous measures of psoriasis severity.

The analysis was supported by Abbott, the maker of adalimumab. The drug had a significantly better benefit-risk profile as measured by the number of days patients spent with at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores while also remaining free of study drug–related adverse events, Dr. Reich reported at the annual congress of the European Academy of Dermatology and Venereology.

The four phase III, double-blind, randomized, placebo-controlled, 12-week clinical trials included REVEAL (J. Am. Acad. Dermatol. 2008;56:106-15) and CHAMPION (Br. J. Dermatol. 2008;158:558-66), studies that pitted adalimumab against placebo in 1,302 subjects. The analysis also included the M10-114 and M10-315 trials, which included 390 patients randomized to briakinumab (Abbott), etanercept, or placebo.

Prior to propensity score weighting, participants in the adalimumab studies differed from those in the etanercept trials in terms of disease duration, percent body surface area involvement, extent of prior medication use, PASI scores, and other important variables. After matching, however, the two groups were closely similar across the board, explained Dr. Reich of the Hamburg (Germany) Dermatology Clinic.

Through 12 weeks of study participation, adalimumab-treated patients spent an average of 22.4 more days at PASI 75 with no study drug–related side effects than did those on placebo in the same two studies. In contrast, etanercept-treated patients spent 11.5 more days than did controls in this optimal state.

At week 4, the proportion of biologic-treated subjects who were PASI 75 responders free of moderate-to-severe study drug–related adverse events was 15.7% in the adalimumab group compared with 5.5% with etanercept. At week 8, these rates climbed to 46.3% in the adalimumab-treated patients and 16.2% in the etanercept group. By week 12, the figures were 58% for adalimumab compared with 39.4% with etanercept.

An obvious limitation of this indirect comparison is the potential for confounding due to unobserved baseline differences. But Dr. Reich said he and his coinvestigators adjusted and balanced for everything they could think of.

"To further adjust for potential differences between trials, outcomes were compared relative to the corresponding placebo arms after applying propensity weights and before comparing across trials. Thus, unobserved factors that equally impact outcomes on the drug and placebo arms would not bias this comparison of adalimumab and etanercept," the dermatologist said.

Dr. Reich has received research grants from and serves as a consultant to Abbott, which supported this analysis, as well as to numerous other pharmaceutical companies.

PRAGUE – Recognizing the slim chances of a direct comparison study of two biologics for treatment of psoriasis, Dr. Kristian Reich and his coworkers have done the next best thing: they’ve conducted an indirect comparison study.

They used existing data from four randomized trials to compare two biologics adalimumab (Humira) and etanercept (Enbrel) and adjusted for between-trial differences in baseline patient demographics, treatment history, and numerous measures of psoriasis severity.

The analysis was supported by Abbott, the maker of adalimumab. The drug had a significantly better benefit-risk profile as measured by the number of days patients spent with at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores while also remaining free of study drug–related adverse events, Dr. Reich reported at the annual congress of the European Academy of Dermatology and Venereology.

The four phase III, double-blind, randomized, placebo-controlled, 12-week clinical trials included REVEAL (J. Am. Acad. Dermatol. 2008;56:106-15) and CHAMPION (Br. J. Dermatol. 2008;158:558-66), studies that pitted adalimumab against placebo in 1,302 subjects. The analysis also included the M10-114 and M10-315 trials, which included 390 patients randomized to briakinumab (Abbott), etanercept, or placebo.

Prior to propensity score weighting, participants in the adalimumab studies differed from those in the etanercept trials in terms of disease duration, percent body surface area involvement, extent of prior medication use, PASI scores, and other important variables. After matching, however, the two groups were closely similar across the board, explained Dr. Reich of the Hamburg (Germany) Dermatology Clinic.

Through 12 weeks of study participation, adalimumab-treated patients spent an average of 22.4 more days at PASI 75 with no study drug–related side effects than did those on placebo in the same two studies. In contrast, etanercept-treated patients spent 11.5 more days than did controls in this optimal state.

At week 4, the proportion of biologic-treated subjects who were PASI 75 responders free of moderate-to-severe study drug–related adverse events was 15.7% in the adalimumab group compared with 5.5% with etanercept. At week 8, these rates climbed to 46.3% in the adalimumab-treated patients and 16.2% in the etanercept group. By week 12, the figures were 58% for adalimumab compared with 39.4% with etanercept.

An obvious limitation of this indirect comparison is the potential for confounding due to unobserved baseline differences. But Dr. Reich said he and his coinvestigators adjusted and balanced for everything they could think of.

"To further adjust for potential differences between trials, outcomes were compared relative to the corresponding placebo arms after applying propensity weights and before comparing across trials. Thus, unobserved factors that equally impact outcomes on the drug and placebo arms would not bias this comparison of adalimumab and etanercept," the dermatologist said.

Dr. Reich has received research grants from and serves as a consultant to Abbott, which supported this analysis, as well as to numerous other pharmaceutical companies.

PRAGUE  – More than half of patients who undergo surgical treatment for hidradenitis suppurativa experience one or more indicators of unmet treatment needs – in other words, a suboptimal result – during the subsequent 12 months, according to Dr. Gregor B. Jemec of the University of Copenhagen.

"Very often hidradenitis suppurativa is considered a disease that is treatable only surgically. This study highlights the need for development of effective nonsurgical treatment options for people with hidradenitis suppurativa," he said at the annual congress of the European Academy of Dermatology and Venereology.

Several medical therapies for hidradenitis suppurativa (HS) are backed by reasonably good evidence, but all of them are off label. No approved therapy exists for this chronic, recurrent, scarring, inflammatory skin disease that affects 1%-4% of U.S. adults.

Dr. Jemec presented a retrospective claims-based analysis of the economic burden of failed HS surgery in the United States.

He and his coinvestigators identified 2,668 patients in the Ingenix Employer Solutions database who underwent surgery for HS within 6 months after being diagnosed with the skin disease. The researchers came up with a list of indicators of unmet needs following surgery: development of surgical complications such as scarring, abscess, fistulization, or septicemia; an inpatient stay, office visit, or emergency department visit for HS; or another HS skin surgery. The investigators asked two questions: How many patients experienced one or more of these adverse outcome indicators within 12 months following surgery, and what was the associated economic cost?

Fifty-one percent of patients experienced one or more of the indicators of unmet needs. Fifty-seven percent of this cohort underwent one or more subsequent skin surgeries, mostly excisions. Twenty-three percent of patients in the unmet needs cohort developed abscesses, 15% had septicemia, 5% had an HS hospitalization, and 4% had an emergency department visit for HS.

Patients with unmet needs following HS surgery were significantly older by a mean of 3 years. They also had more comorbid conditions as reflected in their significantly higher mean Charlson Comorbidity Index score. After adjustment for these and other potential confounding variables in a multivariate analysis, the group with indicators of unmet needs had a 63% greater incidence of hospital admission for HS during follow-up than did those without. They also had a 59% greater rate of emergency department visits for HS and a 35% increase in office visits for the skin disease.

Total health care costs during the 12 months following HS surgery averaged $13,235 for patients with indicators of unmet needs, compared with $8,193 for those who were trouble free after surgery. After multivariate adjustment, costs in the unmet needs group were an average of $3,109 higher, with the bulk of this difference being driven by the increased rate of inpatient stays for HS.

This study was funded by Abbott Laboratories, which is developing its tumor necrosis factor inhibitor adalimumab (Humira) as a therapy for HS. Abbott has two pivotal 36-week, randomized, double-blind, placebo-controlled, multinational phase III clinical trials underway. Dr. Jemec is a consultant to the company and has received research grants from and/or serves as a consultant to multiple other pharmaceutical companies.

PRAGUE  – More than half of patients who undergo surgical treatment for hidradenitis suppurativa experience one or more indicators of unmet treatment needs – in other words, a suboptimal result – during the subsequent 12 months, according to Dr. Gregor B. Jemec of the University of Copenhagen.

"Very often hidradenitis suppurativa is considered a disease that is treatable only surgically. This study highlights the need for development of effective nonsurgical treatment options for people with hidradenitis suppurativa," he said at the annual congress of the European Academy of Dermatology and Venereology.

Several medical therapies for hidradenitis suppurativa (HS) are backed by reasonably good evidence, but all of them are off label. No approved therapy exists for this chronic, recurrent, scarring, inflammatory skin disease that affects 1%-4% of U.S. adults.

Dr. Jemec presented a retrospective claims-based analysis of the economic burden of failed HS surgery in the United States.

He and his coinvestigators identified 2,668 patients in the Ingenix Employer Solutions database who underwent surgery for HS within 6 months after being diagnosed with the skin disease. The researchers came up with a list of indicators of unmet needs following surgery: development of surgical complications such as scarring, abscess, fistulization, or septicemia; an inpatient stay, office visit, or emergency department visit for HS; or another HS skin surgery. The investigators asked two questions: How many patients experienced one or more of these adverse outcome indicators within 12 months following surgery, and what was the associated economic cost?

Fifty-one percent of patients experienced one or more of the indicators of unmet needs. Fifty-seven percent of this cohort underwent one or more subsequent skin surgeries, mostly excisions. Twenty-three percent of patients in the unmet needs cohort developed abscesses, 15% had septicemia, 5% had an HS hospitalization, and 4% had an emergency department visit for HS.

Patients with unmet needs following HS surgery were significantly older by a mean of 3 years. They also had more comorbid conditions as reflected in their significantly higher mean Charlson Comorbidity Index score. After adjustment for these and other potential confounding variables in a multivariate analysis, the group with indicators of unmet needs had a 63% greater incidence of hospital admission for HS during follow-up than did those without. They also had a 59% greater rate of emergency department visits for HS and a 35% increase in office visits for the skin disease.

Total health care costs during the 12 months following HS surgery averaged $13,235 for patients with indicators of unmet needs, compared with $8,193 for those who were trouble free after surgery. After multivariate adjustment, costs in the unmet needs group were an average of $3,109 higher, with the bulk of this difference being driven by the increased rate of inpatient stays for HS.

This study was funded by Abbott Laboratories, which is developing its tumor necrosis factor inhibitor adalimumab (Humira) as a therapy for HS. Abbott has two pivotal 36-week, randomized, double-blind, placebo-controlled, multinational phase III clinical trials underway. Dr. Jemec is a consultant to the company and has received research grants from and/or serves as a consultant to multiple other pharmaceutical companies.

PRAGUE  – More than half of patients who undergo surgical treatment for hidradenitis suppurativa experience one or more indicators of unmet treatment needs – in other words, a suboptimal result – during the subsequent 12 months, according to Dr. Gregor B. Jemec of the University of Copenhagen.

"Very often hidradenitis suppurativa is considered a disease that is treatable only surgically. This study highlights the need for development of effective nonsurgical treatment options for people with hidradenitis suppurativa," he said at the annual congress of the European Academy of Dermatology and Venereology.

Several medical therapies for hidradenitis suppurativa (HS) are backed by reasonably good evidence, but all of them are off label. No approved therapy exists for this chronic, recurrent, scarring, inflammatory skin disease that affects 1%-4% of U.S. adults.

Dr. Jemec presented a retrospective claims-based analysis of the economic burden of failed HS surgery in the United States.

He and his coinvestigators identified 2,668 patients in the Ingenix Employer Solutions database who underwent surgery for HS within 6 months after being diagnosed with the skin disease. The researchers came up with a list of indicators of unmet needs following surgery: development of surgical complications such as scarring, abscess, fistulization, or septicemia; an inpatient stay, office visit, or emergency department visit for HS; or another HS skin surgery. The investigators asked two questions: How many patients experienced one or more of these adverse outcome indicators within 12 months following surgery, and what was the associated economic cost?

Fifty-one percent of patients experienced one or more of the indicators of unmet needs. Fifty-seven percent of this cohort underwent one or more subsequent skin surgeries, mostly excisions. Twenty-three percent of patients in the unmet needs cohort developed abscesses, 15% had septicemia, 5% had an HS hospitalization, and 4% had an emergency department visit for HS.

Patients with unmet needs following HS surgery were significantly older by a mean of 3 years. They also had more comorbid conditions as reflected in their significantly higher mean Charlson Comorbidity Index score. After adjustment for these and other potential confounding variables in a multivariate analysis, the group with indicators of unmet needs had a 63% greater incidence of hospital admission for HS during follow-up than did those without. They also had a 59% greater rate of emergency department visits for HS and a 35% increase in office visits for the skin disease.

Total health care costs during the 12 months following HS surgery averaged $13,235 for patients with indicators of unmet needs, compared with $8,193 for those who were trouble free after surgery. After multivariate adjustment, costs in the unmet needs group were an average of $3,109 higher, with the bulk of this difference being driven by the increased rate of inpatient stays for HS.

This study was funded by Abbott Laboratories, which is developing its tumor necrosis factor inhibitor adalimumab (Humira) as a therapy for HS. Abbott has two pivotal 36-week, randomized, double-blind, placebo-controlled, multinational phase III clinical trials underway. Dr. Jemec is a consultant to the company and has received research grants from and/or serves as a consultant to multiple other pharmaceutical companies.

PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.

Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.

He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.

The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.

The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.

Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.

The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.

This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.

PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.

Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.

He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.

The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.

The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.

Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.

The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.

This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.

PRAGUE – Adding short courses of clobetasol propionate foam to etanercept resulted in improved outcomes compared with etanercept alone in patients with moderate to severe plaque psoriasis in a large, multicenter phase III randomized trial.

Moreover, the boost in efficacy that resulted from add-on short-course therapy with the potent topical steroid came at no cost in terms of additional side effects, according to Dr. Mark G. Lebwohl, professor and chair of dermatology at Mount Sinai School of Medicine, New York.

He reported on 592 psoriasis patients who were randomized to etanercept at 50 mg twice weekly for 12 weeks alone or with the option of using clobetasol propionate foam twice daily for up to 2 weeks during weeks 11-12 as needed to clear lesions. Of patients with the opportunity to resort to short-course topical steroid therapy, 85% did so during week 11 and 82% exercised that option in week 12.

The primary end point was a 75% improvement in the Psoriasis Area and Severity Index score, or PASI 75, at week 12 compared with baseline as determined by blinded investigators. This occurred in 65% of patients in the dual-therapy group vs. 48% of those on etanercept alone.

The incremental improvement in PASI 90 seen in the etanercept plus clobetasol propionate group was similarly impressive: a 30% PASI 90 rate compared with 19% with etanercept alone, Dr. Lebwohl noted at the annual congress of the European Academy of Dermatology and Venereology.

Patient satisfaction scores were significantly higher in the dual-therapy arm as well. Of patients randomized to etanercept plus clobetasol propionate, 87% said they were satisfied or very satisfied with their therapy, vs. 78% on etanercept alone.

The rate of treatment-related adverse events leading to discontinuation of therapy was low in both study arms: 0.7% with etanercept plus short-course topical steroid therapy and 1.3% with etanercept alone. No serious treatment-related adverse events occurred in the dual-therapy group, and there was only one in patients assigned to etanercept alone.

This phase III study was sponsored by Amgen. Dr. Lebwohl reported that he serves as a consultant to Amgen as well as numerous other pharmaceutical companies involved in developing dermatologic drugs.

LONDON – Frovatriptan may be the triptan of choice for the acute treatment of menstrual migraine attacks, according to reanalyses of data from double-blind, randomized crossover trials involving the drug.

Frovatriptan’s lengthy half-life – the longest of all the triptans – and prolonged duration of clinical effect make it a particularly attractive option for the treatment of menstrual migraine attacks, which are typically longer in duration and more susceptible to relapse than migraine not related to menstruation, said Dr. Lidia Savi, a neurologist at the University of Turin (Italy).

At the European Headache and Migraine Trust International Congress, she presented a secondary analysis of data from a published, double-blind, randomized, multicenter crossover trial of frovatriptan (Frova) versus almotriptan (Axert) for the acute treatment of migraine (J. Headache Pain 2011;12:361-8). Both men and women were included in the parent study. The newer secondary analysis was restricted to the 67 participants with regular menstrual cycles.

In 155 menstrual migraine attacks treated in double-blind fashion, the two triptans displayed similar short-term efficacy, as reflected in pain relief and pain-free episodes 2 and 4 hours post treatment. However, the recurrence rate within 48 hours after treatment was just 9% in frovatriptan-treated episodes, significantly less than the 24% rate for almotriptan (J. Headache Pain 2012;13:401-6).

In a separate presentation, Dr. Anne MacGregor emphasized that menstrually related migraine is a distinct clinical entity. Affected women find it considerably more problematic than migraine occurring at other times of the menstrual cycle.

She cited a study by other investigators who prospectively studied headache episodes in 107 women with frequent and disabling migraine attacks, both menstrually related and otherwise. The menstrually related attacks were significantly less likely to be pain free at 2 hours post treatment, were more likely to last longer than 72 hours, were more severe, had more associated symptoms, were more susceptible to relapse, and inflicted greater disability (Cephalalgia 2010;30:1187-94).

When not managed effectively, menstrual migraine attacks often cause women to develop a greater fear of migraine, with resultant added psychological and functional disability between episodes, said Dr. MacGregor of the Barts Sexual Health Centre at St. Bartholomew’s Hospital and the London School of Medicine and Dentistry.

"Frovatriptan is something that can give these patients that little extra bit of control. This is something quite positive that we can take home as a message to our patients: Frovatriptan is an option worth trying for menstrual attacks of migraine," she added.

Dr. Gianni Allais presented a pooled analysis of Dr. Savi’s study plus two other published Italian randomized, double-blind crossover clinical trials of frovatriptan versus rizatriptan (Maxalt) (J. Headache Pain 2011;12:609-15) and zolmitriptan (Zomig) (Neurol. Sci. 2011;32[suppl. 1]:S99-104). The pooled subgroup analysis covered the 187 women with at least one episode of menstrual migraine treated with frovatriptan and one episode treated with one of the other triptans.

Rates of being pain free and having pain relief 2 and 4 hours post treatment were similar across the board. However, recurrence rates were significantly lower for frovatriptan-treated episodes than for those treated with any of the other agents. At 24 hours of follow-up, the recurrence rate was 11% following frovatriptan versus 24% collectively for the comparator triptans. The 48-hour recurrence rate was 15% with frovatriptan, compared with 26% for the other triptans in this recently published pooled analysis (Neurol. Sci. 2012;33[suppl. 1]:S65-9), reported Dr. Allais of the women’s headache center at the University of Turin.

The frovastatin studies were funded by the Menarini Group, which markets the triptan in Italy. Dr. Savi, Dr. MacGregor, and Dr. Allais serve as consultants to the company.

LONDON – Frovatriptan may be the triptan of choice for the acute treatment of menstrual migraine attacks, according to reanalyses of data from double-blind, randomized crossover trials involving the drug.

Frovatriptan’s lengthy half-life – the longest of all the triptans – and prolonged duration of clinical effect make it a particularly attractive option for the treatment of menstrual migraine attacks, which are typically longer in duration and more susceptible to relapse than migraine not related to menstruation, said Dr. Lidia Savi, a neurologist at the University of Turin (Italy).

At the European Headache and Migraine Trust International Congress, she presented a secondary analysis of data from a published, double-blind, randomized, multicenter crossover trial of frovatriptan (Frova) versus almotriptan (Axert) for the acute treatment of migraine (J. Headache Pain 2011;12:361-8). Both men and women were included in the parent study. The newer secondary analysis was restricted to the 67 participants with regular menstrual cycles.

In 155 menstrual migraine attacks treated in double-blind fashion, the two triptans displayed similar short-term efficacy, as reflected in pain relief and pain-free episodes 2 and 4 hours post treatment. However, the recurrence rate within 48 hours after treatment was just 9% in frovatriptan-treated episodes, significantly less than the 24% rate for almotriptan (J. Headache Pain 2012;13:401-6).

In a separate presentation, Dr. Anne MacGregor emphasized that menstrually related migraine is a distinct clinical entity. Affected women find it considerably more problematic than migraine occurring at other times of the menstrual cycle.

She cited a study by other investigators who prospectively studied headache episodes in 107 women with frequent and disabling migraine attacks, both menstrually related and otherwise. The menstrually related attacks were significantly less likely to be pain free at 2 hours post treatment, were more likely to last longer than 72 hours, were more severe, had more associated symptoms, were more susceptible to relapse, and inflicted greater disability (Cephalalgia 2010;30:1187-94).

When not managed effectively, menstrual migraine attacks often cause women to develop a greater fear of migraine, with resultant added psychological and functional disability between episodes, said Dr. MacGregor of the Barts Sexual Health Centre at St. Bartholomew’s Hospital and the London School of Medicine and Dentistry.

"Frovatriptan is something that can give these patients that little extra bit of control. This is something quite positive that we can take home as a message to our patients: Frovatriptan is an option worth trying for menstrual attacks of migraine," she added.

Dr. Gianni Allais presented a pooled analysis of Dr. Savi’s study plus two other published Italian randomized, double-blind crossover clinical trials of frovatriptan versus rizatriptan (Maxalt) (J. Headache Pain 2011;12:609-15) and zolmitriptan (Zomig) (Neurol. Sci. 2011;32[suppl. 1]:S99-104). The pooled subgroup analysis covered the 187 women with at least one episode of menstrual migraine treated with frovatriptan and one episode treated with one of the other triptans.

Rates of being pain free and having pain relief 2 and 4 hours post treatment were similar across the board. However, recurrence rates were significantly lower for frovatriptan-treated episodes than for those treated with any of the other agents. At 24 hours of follow-up, the recurrence rate was 11% following frovatriptan versus 24% collectively for the comparator triptans. The 48-hour recurrence rate was 15% with frovatriptan, compared with 26% for the other triptans in this recently published pooled analysis (Neurol. Sci. 2012;33[suppl. 1]:S65-9), reported Dr. Allais of the women’s headache center at the University of Turin.

The frovastatin studies were funded by the Menarini Group, which markets the triptan in Italy. Dr. Savi, Dr. MacGregor, and Dr. Allais serve as consultants to the company.

LONDON – Frovatriptan may be the triptan of choice for the acute treatment of menstrual migraine attacks, according to reanalyses of data from double-blind, randomized crossover trials involving the drug.

Frovatriptan’s lengthy half-life – the longest of all the triptans – and prolonged duration of clinical effect make it a particularly attractive option for the treatment of menstrual migraine attacks, which are typically longer in duration and more susceptible to relapse than migraine not related to menstruation, said Dr. Lidia Savi, a neurologist at the University of Turin (Italy).

At the European Headache and Migraine Trust International Congress, she presented a secondary analysis of data from a published, double-blind, randomized, multicenter crossover trial of frovatriptan (Frova) versus almotriptan (Axert) for the acute treatment of migraine (J. Headache Pain 2011;12:361-8). Both men and women were included in the parent study. The newer secondary analysis was restricted to the 67 participants with regular menstrual cycles.

In 155 menstrual migraine attacks treated in double-blind fashion, the two triptans displayed similar short-term efficacy, as reflected in pain relief and pain-free episodes 2 and 4 hours post treatment. However, the recurrence rate within 48 hours after treatment was just 9% in frovatriptan-treated episodes, significantly less than the 24% rate for almotriptan (J. Headache Pain 2012;13:401-6).

In a separate presentation, Dr. Anne MacGregor emphasized that menstrually related migraine is a distinct clinical entity. Affected women find it considerably more problematic than migraine occurring at other times of the menstrual cycle.

She cited a study by other investigators who prospectively studied headache episodes in 107 women with frequent and disabling migraine attacks, both menstrually related and otherwise. The menstrually related attacks were significantly less likely to be pain free at 2 hours post treatment, were more likely to last longer than 72 hours, were more severe, had more associated symptoms, were more susceptible to relapse, and inflicted greater disability (Cephalalgia 2010;30:1187-94).

When not managed effectively, menstrual migraine attacks often cause women to develop a greater fear of migraine, with resultant added psychological and functional disability between episodes, said Dr. MacGregor of the Barts Sexual Health Centre at St. Bartholomew’s Hospital and the London School of Medicine and Dentistry.

"Frovatriptan is something that can give these patients that little extra bit of control. This is something quite positive that we can take home as a message to our patients: Frovatriptan is an option worth trying for menstrual attacks of migraine," she added.

Dr. Gianni Allais presented a pooled analysis of Dr. Savi’s study plus two other published Italian randomized, double-blind crossover clinical trials of frovatriptan versus rizatriptan (Maxalt) (J. Headache Pain 2011;12:609-15) and zolmitriptan (Zomig) (Neurol. Sci. 2011;32[suppl. 1]:S99-104). The pooled subgroup analysis covered the 187 women with at least one episode of menstrual migraine treated with frovatriptan and one episode treated with one of the other triptans.

Rates of being pain free and having pain relief 2 and 4 hours post treatment were similar across the board. However, recurrence rates were significantly lower for frovatriptan-treated episodes than for those treated with any of the other agents. At 24 hours of follow-up, the recurrence rate was 11% following frovatriptan versus 24% collectively for the comparator triptans. The 48-hour recurrence rate was 15% with frovatriptan, compared with 26% for the other triptans in this recently published pooled analysis (Neurol. Sci. 2012;33[suppl. 1]:S65-9), reported Dr. Allais of the women’s headache center at the University of Turin.

The frovastatin studies were funded by the Menarini Group, which markets the triptan in Italy. Dr. Savi, Dr. MacGregor, and Dr. Allais serve as consultants to the company.

LONDON – Plain old aspirin proved far and away the most effective of the various agents used for prophylaxis of migraine with aura in an Italian study, with 86% of aspirin-treated patients reporting at least a 50% reduction in frequency of attacks.

"We found the probability of treatment success with acetylsalicylic acid at 300 mg once daily was about six times greater than with other prophylactic agents," Dr. Lidia T. Savi reported at the European Headache and Migraine Trust International Congress.

©jimdeli/Fotolia.com

Dr. Savi, a neurologist at the University of Turin (Italy), presented a retrospective analysis of 194 consecutive patients at the university’s headache center who were placed on prophylactic therapy for migraine with aura. Ninety were on aspirin at 300 mg/day. The rest were on various widely used prophylactic medications, with propranolol and topiramate topping the list.

The primary end point was treatment success as defined at week 32 by at least a 50% reduction in the frequency of attacks of migraine with aura, compared with baseline. Eighty-six percent of patients on aspirin for prophylaxis met this end point; indeed, 41% of the aspirin-treated group also met the more rigorous standard of ‘extremely improved’ as defined by a 75% reduction in attack frequency. Fourteen percent of patients were rated unimproved.

In contrast, 46% of patients on prophylactic agents other than aspirin were unimproved. Only 17% were judged extremely improved and 37% were improved.

Aspirin prophylaxis at the 300 mg dose was, as expected, very well tolerated, with nobody switching to another agent within 32 weeks due to side effects. Moreover, treatment success rates in the aspirin group were the same at 16 weeks as at 32 weeks, so patients and their physicians can expect to see evidence of response to prophylactic aspirin in a relatively short time, Dr. Savi continued.

In a multivariate analysis adjusted for age, gender, disease duration, and other variables, only prophylactic aspirin was independently associated with a positive treatment response. Patients on prophylactic aspirin were an adjusted 6.3-fold more likely than were those on other drugs to have at least a 50% reduction in migraine with aura frequency.

The prevalence of migraine with aura in the general population is estimated at 1%-5%. Most affected patients find the aura more disturbing and disruptive than the subsequent head pain.

Prior studies comparing prophylactic agents for migraine with aura have typically reported aspirin to be only mildly effective. However, these studies often contained only small numbers of patients and muddied the waters by mixing together subjects who had migraine with aura and those who had migraine without aura, according to Dr. Savi.

A double-blind, placebo-controlled study with a larger patient sample will be needed to confirm the Italian findings, she added.

Prophylactic aspirin’s mechanism of benefit in migraine with aura isn’t known. But the disorder has been linked to platelet dysfunction, and Dr. Savi’s hypothesis is that daily aspirin prevents migraine with aura attacks by curbing formation of microemboli.

Audience member Dr. Jean Schoenen of the University of Liege (Belgium) asked how many patients in the Italian series were on lamotrigine, which he considers the best agent for prevention of attacks of migraine with aura. Dr. Savi replied that none were. She said she and her colleagues seldom prescribe lamotrigine (Lamictal) anymore because they’ve found the discontinuation rate is so high.

Dr. Savi reported having no financial conflicts.

LONDON – Plain old aspirin proved far and away the most effective of the various agents used for prophylaxis of migraine with aura in an Italian study, with 86% of aspirin-treated patients reporting at least a 50% reduction in frequency of attacks.

"We found the probability of treatment success with acetylsalicylic acid at 300 mg once daily was about six times greater than with other prophylactic agents," Dr. Lidia T. Savi reported at the European Headache and Migraine Trust International Congress.

©jimdeli/Fotolia.com

Dr. Savi, a neurologist at the University of Turin (Italy), presented a retrospective analysis of 194 consecutive patients at the university’s headache center who were placed on prophylactic therapy for migraine with aura. Ninety were on aspirin at 300 mg/day. The rest were on various widely used prophylactic medications, with propranolol and topiramate topping the list.

The primary end point was treatment success as defined at week 32 by at least a 50% reduction in the frequency of attacks of migraine with aura, compared with baseline. Eighty-six percent of patients on aspirin for prophylaxis met this end point; indeed, 41% of the aspirin-treated group also met the more rigorous standard of ‘extremely improved’ as defined by a 75% reduction in attack frequency. Fourteen percent of patients were rated unimproved.

In contrast, 46% of patients on prophylactic agents other than aspirin were unimproved. Only 17% were judged extremely improved and 37% were improved.

Aspirin prophylaxis at the 300 mg dose was, as expected, very well tolerated, with nobody switching to another agent within 32 weeks due to side effects. Moreover, treatment success rates in the aspirin group were the same at 16 weeks as at 32 weeks, so patients and their physicians can expect to see evidence of response to prophylactic aspirin in a relatively short time, Dr. Savi continued.

In a multivariate analysis adjusted for age, gender, disease duration, and other variables, only prophylactic aspirin was independently associated with a positive treatment response. Patients on prophylactic aspirin were an adjusted 6.3-fold more likely than were those on other drugs to have at least a 50% reduction in migraine with aura frequency.

The prevalence of migraine with aura in the general population is estimated at 1%-5%. Most affected patients find the aura more disturbing and disruptive than the subsequent head pain.

Prior studies comparing prophylactic agents for migraine with aura have typically reported aspirin to be only mildly effective. However, these studies often contained only small numbers of patients and muddied the waters by mixing together subjects who had migraine with aura and those who had migraine without aura, according to Dr. Savi.

A double-blind, placebo-controlled study with a larger patient sample will be needed to confirm the Italian findings, she added.

Prophylactic aspirin’s mechanism of benefit in migraine with aura isn’t known. But the disorder has been linked to platelet dysfunction, and Dr. Savi’s hypothesis is that daily aspirin prevents migraine with aura attacks by curbing formation of microemboli.

Audience member Dr. Jean Schoenen of the University of Liege (Belgium) asked how many patients in the Italian series were on lamotrigine, which he considers the best agent for prevention of attacks of migraine with aura. Dr. Savi replied that none were. She said she and her colleagues seldom prescribe lamotrigine (Lamictal) anymore because they’ve found the discontinuation rate is so high.

Dr. Savi reported having no financial conflicts.

LONDON – Plain old aspirin proved far and away the most effective of the various agents used for prophylaxis of migraine with aura in an Italian study, with 86% of aspirin-treated patients reporting at least a 50% reduction in frequency of attacks.

"We found the probability of treatment success with acetylsalicylic acid at 300 mg once daily was about six times greater than with other prophylactic agents," Dr. Lidia T. Savi reported at the European Headache and Migraine Trust International Congress.

©jimdeli/Fotolia.com

Dr. Savi, a neurologist at the University of Turin (Italy), presented a retrospective analysis of 194 consecutive patients at the university’s headache center who were placed on prophylactic therapy for migraine with aura. Ninety were on aspirin at 300 mg/day. The rest were on various widely used prophylactic medications, with propranolol and topiramate topping the list.

The primary end point was treatment success as defined at week 32 by at least a 50% reduction in the frequency of attacks of migraine with aura, compared with baseline. Eighty-six percent of patients on aspirin for prophylaxis met this end point; indeed, 41% of the aspirin-treated group also met the more rigorous standard of ‘extremely improved’ as defined by a 75% reduction in attack frequency. Fourteen percent of patients were rated unimproved.

In contrast, 46% of patients on prophylactic agents other than aspirin were unimproved. Only 17% were judged extremely improved and 37% were improved.

Aspirin prophylaxis at the 300 mg dose was, as expected, very well tolerated, with nobody switching to another agent within 32 weeks due to side effects. Moreover, treatment success rates in the aspirin group were the same at 16 weeks as at 32 weeks, so patients and their physicians can expect to see evidence of response to prophylactic aspirin in a relatively short time, Dr. Savi continued.

In a multivariate analysis adjusted for age, gender, disease duration, and other variables, only prophylactic aspirin was independently associated with a positive treatment response. Patients on prophylactic aspirin were an adjusted 6.3-fold more likely than were those on other drugs to have at least a 50% reduction in migraine with aura frequency.

The prevalence of migraine with aura in the general population is estimated at 1%-5%. Most affected patients find the aura more disturbing and disruptive than the subsequent head pain.

Prior studies comparing prophylactic agents for migraine with aura have typically reported aspirin to be only mildly effective. However, these studies often contained only small numbers of patients and muddied the waters by mixing together subjects who had migraine with aura and those who had migraine without aura, according to Dr. Savi.

A double-blind, placebo-controlled study with a larger patient sample will be needed to confirm the Italian findings, she added.

Prophylactic aspirin’s mechanism of benefit in migraine with aura isn’t known. But the disorder has been linked to platelet dysfunction, and Dr. Savi’s hypothesis is that daily aspirin prevents migraine with aura attacks by curbing formation of microemboli.

Audience member Dr. Jean Schoenen of the University of Liege (Belgium) asked how many patients in the Italian series were on lamotrigine, which he considers the best agent for prevention of attacks of migraine with aura. Dr. Savi replied that none were. She said she and her colleagues seldom prescribe lamotrigine (Lamictal) anymore because they’ve found the discontinuation rate is so high.

Dr. Savi reported having no financial conflicts.

PRAGUE – Patients with the common chronic inflammatory skin disease hidradenitis suppurativa have a sharply increased prevalence of metabolic syndrome, according to the results of three recent case-control studies.

"I think we can say that we have a uniform pattern from three studies showing hidradenitis suppurativa patients have increased risk for the metabolic syndrome, with odds ratios up to 5.8," Dr. Iben M. Miller said at the annual congress of the European Academy of Dermatology and Venereology.

"The implication is that we need to consider screening our hidradenitis suppurativa patients for cardiovascular risk factors, and – perhaps the most important and difficult thing – to help these patients with lifestyle interventions," added Dr. Miller, a dermatologist at the University of Copenhagen.

She presented updates on two case-control studies, which she is conducting in Denmark, as well as highlights from a third study recently published by dermatologists from the University Hospital Charitè in Berlin.

One of her studies included 374 patients with hidradenitis suppurativa and 15,000 controls drawn from the Danish General Suburban Population Study (GESUS), an ongoing study of the adults initiated in 2010, with enrollment at 15,500 and climbing. Participants are evaluated via detailed questionnaires, periodic physical examinations, and blood work.

All of the hidradenitis suppurativa study patients were adjusted for age, smoking status, and sex because patients with hidradenitis suppurativa are considerably younger, more likely to be female, and have a far greater prevalence of smoking than do control patients.

The hidradenitis suppurativa patients in GESUS proved to have an adjusted 2.35-fold greater likelihood of meeting criteria for metabolic syndrome than do control patients. They had a 2.79-fold increased odds of carrying the diagnosis of diabetes mellitus. They were also 2.36 times more likely to be obese and 2.33-fold more likely to have an increased waist circumference. The hidradenitis suppurativa group also was saddled with increased rates of hypertriglyceridemia and low HDL, with a mean serum triglyceride of 159 mg/dL, compared with 142 mg/dL in control patients, and a mean HDL of 51 mg/dL vs. 57 mg/dL in control patients.

The sole component of metabolic syndrome that was not more prominent in the hidradenitis suppurativa group was hypertension; the 16% increased prevalence of high blood pressure among patients with hidradenitis suppurativa didn’t achieve statistical significance, Dr. Miller noted.

The hidradenitis suppurativa group had an adjusted 1.69-fold greater prevalence of ischemic heart disease and a 1.14-fold greater likelihood of a history of stroke.

Dr. Miller’s second case-control study involved 31 Danish adults hospitalized for surgical treatment of hidradenitis suppurativa and the same 15,000 controls from GESUS. Of note, they were also significantly younger, with a mean age of 40.3 years, compared with 45.9 years in the population-based hidradenitis suppurativa cohort and 54.5 years in control patients. They were also more likely to be female and smokers than the 374 hidradenitis suppurativa patients drawn from GESUS.

The hospitalized hidradenitis suppurativa patients were an adjusted 5.8 times more likely to fulfill the criteria for metabolic syndrome than control patients. They also had a 5.47-fold increased risk of being diagnosed with diabetes. Their rates of all the other metabolic syndrome components were higher than in the GESUS hidradenitis suppurativa patients, as well. "I think that’s probably because the hospital cases have a greater degree of disease severity," said Dr. Miller.

The recently published German case-control study (PLoS ONE 7: e31810. [doi:10.1371/journal.pone.0031810]) included 80 patients hospitalized for surgical treatment of hidradenitis suppurativa and 100 age- and sex-matched controls. The prevalence of metabolic syndrome was 40% among the hidradenitis suppurativa cohort, compared with 13% in controls. The adjusted odds ratio was 4.46%.

The hidradenitis suppurativa group had a 5.88-fold increased likelihood of central obesity, a 4.09-fold greater rate of hyperglycemia, a 2.24-fold increase in hypertriglyceridemia, and 4.56-fold greater odds of low HDL.

An increased prevalence of metabolic syndrome has previously been shown in patients having other chronic inflammatory diseases, including psoriasis and rheumatoid arthritis. The German study provides the first published evidence that the same is true for hidradenitis suppurativa, a disease that affects up to 4% of the adult population, noted Dr. Miller.

The German dermatologists noted in their study results that the prevalence of metabolic syndrome and degree of metabolic derangement appear to be even greater among hidradenitis suppurativa patients than in those with psoriasis, particularly in light of the fact that patients with hidradenitis suppurativa tend to develop metabolic syndrome at a younger age.

As to the mechanism, the investigators reported that chronic inflammation may not be the driving force behind development of metabolic syndrome in patients with hidradenitis suppurativa. Just the opposite: They speculated that metabolic abnormalities may actually trigger hidradenitis suppurativa. Dr. Miller deemed that an intriguing hypothesis that’s far from proven.

Audience members said these cross-sectional case-control studies can’t demonstrate causality, which would require prospective studies. Dr. Miller agreed. "I think we should be careful about saying what causes what. We’ve shown an association. It could all be due to patient lifestyle. These patients do get depressed, and maybe they sit around at home and get obese, and those fat cells do make inflammatory cytokines," she said.

However, the GESUS study contains information on participants’ physical activity and diet that Dr. Miller is now analyzing. She believes the results will shed light on the mechanism underlying the association between hidradenitis suppurativa and metabolic syndrome.

Hidradenitis suppurativa manifests as extremely painful, chronic, scarring abscesses, cysts, nonhealing tracts, and localized infections affecting mostly intertriginous sites including the underarms, groin, and buttocks.

The GESUS study is funded by the Danish Agency for Science, Technology and Innovation. Dr. Miller reported having no financial conflicts. The German study was unsponsored.

PRAGUE – Patients with the common chronic inflammatory skin disease hidradenitis suppurativa have a sharply increased prevalence of metabolic syndrome, according to the results of three recent case-control studies.

"I think we can say that we have a uniform pattern from three studies showing hidradenitis suppurativa patients have increased risk for the metabolic syndrome, with odds ratios up to 5.8," Dr. Iben M. Miller said at the annual congress of the European Academy of Dermatology and Venereology.

"The implication is that we need to consider screening our hidradenitis suppurativa patients for cardiovascular risk factors, and – perhaps the most important and difficult thing – to help these patients with lifestyle interventions," added Dr. Miller, a dermatologist at the University of Copenhagen.

She presented updates on two case-control studies, which she is conducting in Denmark, as well as highlights from a third study recently published by dermatologists from the University Hospital Charitè in Berlin.

One of her studies included 374 patients with hidradenitis suppurativa and 15,000 controls drawn from the Danish General Suburban Population Study (GESUS), an ongoing study of the adults initiated in 2010, with enrollment at 15,500 and climbing. Participants are evaluated via detailed questionnaires, periodic physical examinations, and blood work.

All of the hidradenitis suppurativa study patients were adjusted for age, smoking status, and sex because patients with hidradenitis suppurativa are considerably younger, more likely to be female, and have a far greater prevalence of smoking than do control patients.

The hidradenitis suppurativa patients in GESUS proved to have an adjusted 2.35-fold greater likelihood of meeting criteria for metabolic syndrome than do control patients. They had a 2.79-fold increased odds of carrying the diagnosis of diabetes mellitus. They were also 2.36 times more likely to be obese and 2.33-fold more likely to have an increased waist circumference. The hidradenitis suppurativa group also was saddled with increased rates of hypertriglyceridemia and low HDL, with a mean serum triglyceride of 159 mg/dL, compared with 142 mg/dL in control patients, and a mean HDL of 51 mg/dL vs. 57 mg/dL in control patients.

The sole component of metabolic syndrome that was not more prominent in the hidradenitis suppurativa group was hypertension; the 16% increased prevalence of high blood pressure among patients with hidradenitis suppurativa didn’t achieve statistical significance, Dr. Miller noted.

The hidradenitis suppurativa group had an adjusted 1.69-fold greater prevalence of ischemic heart disease and a 1.14-fold greater likelihood of a history of stroke.

Dr. Miller’s second case-control study involved 31 Danish adults hospitalized for surgical treatment of hidradenitis suppurativa and the same 15,000 controls from GESUS. Of note, they were also significantly younger, with a mean age of 40.3 years, compared with 45.9 years in the population-based hidradenitis suppurativa cohort and 54.5 years in control patients. They were also more likely to be female and smokers than the 374 hidradenitis suppurativa patients drawn from GESUS.

The hospitalized hidradenitis suppurativa patients were an adjusted 5.8 times more likely to fulfill the criteria for metabolic syndrome than control patients. They also had a 5.47-fold increased risk of being diagnosed with diabetes. Their rates of all the other metabolic syndrome components were higher than in the GESUS hidradenitis suppurativa patients, as well. "I think that’s probably because the hospital cases have a greater degree of disease severity," said Dr. Miller.

The recently published German case-control study (PLoS ONE 7: e31810. [doi:10.1371/journal.pone.0031810]) included 80 patients hospitalized for surgical treatment of hidradenitis suppurativa and 100 age- and sex-matched controls. The prevalence of metabolic syndrome was 40% among the hidradenitis suppurativa cohort, compared with 13% in controls. The adjusted odds ratio was 4.46%.

The hidradenitis suppurativa group had a 5.88-fold increased likelihood of central obesity, a 4.09-fold greater rate of hyperglycemia, a 2.24-fold increase in hypertriglyceridemia, and 4.56-fold greater odds of low HDL.

An increased prevalence of metabolic syndrome has previously been shown in patients having other chronic inflammatory diseases, including psoriasis and rheumatoid arthritis. The German study provides the first published evidence that the same is true for hidradenitis suppurativa, a disease that affects up to 4% of the adult population, noted Dr. Miller.

The German dermatologists noted in their study results that the prevalence of metabolic syndrome and degree of metabolic derangement appear to be even greater among hidradenitis suppurativa patients than in those with psoriasis, particularly in light of the fact that patients with hidradenitis suppurativa tend to develop metabolic syndrome at a younger age.

As to the mechanism, the investigators reported that chronic inflammation may not be the driving force behind development of metabolic syndrome in patients with hidradenitis suppurativa. Just the opposite: They speculated that metabolic abnormalities may actually trigger hidradenitis suppurativa. Dr. Miller deemed that an intriguing hypothesis that’s far from proven.

Audience members said these cross-sectional case-control studies can’t demonstrate causality, which would require prospective studies. Dr. Miller agreed. "I think we should be careful about saying what causes what. We’ve shown an association. It could all be due to patient lifestyle. These patients do get depressed, and maybe they sit around at home and get obese, and those fat cells do make inflammatory cytokines," she said.

However, the GESUS study contains information on participants’ physical activity and diet that Dr. Miller is now analyzing. She believes the results will shed light on the mechanism underlying the association between hidradenitis suppurativa and metabolic syndrome.

Hidradenitis suppurativa manifests as extremely painful, chronic, scarring abscesses, cysts, nonhealing tracts, and localized infections affecting mostly intertriginous sites including the underarms, groin, and buttocks.

The GESUS study is funded by the Danish Agency for Science, Technology and Innovation. Dr. Miller reported having no financial conflicts. The German study was unsponsored.

PRAGUE – Patients with the common chronic inflammatory skin disease hidradenitis suppurativa have a sharply increased prevalence of metabolic syndrome, according to the results of three recent case-control studies.

"I think we can say that we have a uniform pattern from three studies showing hidradenitis suppurativa patients have increased risk for the metabolic syndrome, with odds ratios up to 5.8," Dr. Iben M. Miller said at the annual congress of the European Academy of Dermatology and Venereology.

"The implication is that we need to consider screening our hidradenitis suppurativa patients for cardiovascular risk factors, and – perhaps the most important and difficult thing – to help these patients with lifestyle interventions," added Dr. Miller, a dermatologist at the University of Copenhagen.

She presented updates on two case-control studies, which she is conducting in Denmark, as well as highlights from a third study recently published by dermatologists from the University Hospital Charitè in Berlin.

One of her studies included 374 patients with hidradenitis suppurativa and 15,000 controls drawn from the Danish General Suburban Population Study (GESUS), an ongoing study of the adults initiated in 2010, with enrollment at 15,500 and climbing. Participants are evaluated via detailed questionnaires, periodic physical examinations, and blood work.

All of the hidradenitis suppurativa study patients were adjusted for age, smoking status, and sex because patients with hidradenitis suppurativa are considerably younger, more likely to be female, and have a far greater prevalence of smoking than do control patients.

The hidradenitis suppurativa patients in GESUS proved to have an adjusted 2.35-fold greater likelihood of meeting criteria for metabolic syndrome than do control patients. They had a 2.79-fold increased odds of carrying the diagnosis of diabetes mellitus. They were also 2.36 times more likely to be obese and 2.33-fold more likely to have an increased waist circumference. The hidradenitis suppurativa group also was saddled with increased rates of hypertriglyceridemia and low HDL, with a mean serum triglyceride of 159 mg/dL, compared with 142 mg/dL in control patients, and a mean HDL of 51 mg/dL vs. 57 mg/dL in control patients.

The sole component of metabolic syndrome that was not more prominent in the hidradenitis suppurativa group was hypertension; the 16% increased prevalence of high blood pressure among patients with hidradenitis suppurativa didn’t achieve statistical significance, Dr. Miller noted.

The hidradenitis suppurativa group had an adjusted 1.69-fold greater prevalence of ischemic heart disease and a 1.14-fold greater likelihood of a history of stroke.

Dr. Miller’s second case-control study involved 31 Danish adults hospitalized for surgical treatment of hidradenitis suppurativa and the same 15,000 controls from GESUS. Of note, they were also significantly younger, with a mean age of 40.3 years, compared with 45.9 years in the population-based hidradenitis suppurativa cohort and 54.5 years in control patients. They were also more likely to be female and smokers than the 374 hidradenitis suppurativa patients drawn from GESUS.

The hospitalized hidradenitis suppurativa patients were an adjusted 5.8 times more likely to fulfill the criteria for metabolic syndrome than control patients. They also had a 5.47-fold increased risk of being diagnosed with diabetes. Their rates of all the other metabolic syndrome components were higher than in the GESUS hidradenitis suppurativa patients, as well. "I think that’s probably because the hospital cases have a greater degree of disease severity," said Dr. Miller.

The recently published German case-control study (PLoS ONE 7: e31810. [doi:10.1371/journal.pone.0031810]) included 80 patients hospitalized for surgical treatment of hidradenitis suppurativa and 100 age- and sex-matched controls. The prevalence of metabolic syndrome was 40% among the hidradenitis suppurativa cohort, compared with 13% in controls. The adjusted odds ratio was 4.46%.

The hidradenitis suppurativa group had a 5.88-fold increased likelihood of central obesity, a 4.09-fold greater rate of hyperglycemia, a 2.24-fold increase in hypertriglyceridemia, and 4.56-fold greater odds of low HDL.

An increased prevalence of metabolic syndrome has previously been shown in patients having other chronic inflammatory diseases, including psoriasis and rheumatoid arthritis. The German study provides the first published evidence that the same is true for hidradenitis suppurativa, a disease that affects up to 4% of the adult population, noted Dr. Miller.

The German dermatologists noted in their study results that the prevalence of metabolic syndrome and degree of metabolic derangement appear to be even greater among hidradenitis suppurativa patients than in those with psoriasis, particularly in light of the fact that patients with hidradenitis suppurativa tend to develop metabolic syndrome at a younger age.

As to the mechanism, the investigators reported that chronic inflammation may not be the driving force behind development of metabolic syndrome in patients with hidradenitis suppurativa. Just the opposite: They speculated that metabolic abnormalities may actually trigger hidradenitis suppurativa. Dr. Miller deemed that an intriguing hypothesis that’s far from proven.

Audience members said these cross-sectional case-control studies can’t demonstrate causality, which would require prospective studies. Dr. Miller agreed. "I think we should be careful about saying what causes what. We’ve shown an association. It could all be due to patient lifestyle. These patients do get depressed, and maybe they sit around at home and get obese, and those fat cells do make inflammatory cytokines," she said.

However, the GESUS study contains information on participants’ physical activity and diet that Dr. Miller is now analyzing. She believes the results will shed light on the mechanism underlying the association between hidradenitis suppurativa and metabolic syndrome.

Hidradenitis suppurativa manifests as extremely painful, chronic, scarring abscesses, cysts, nonhealing tracts, and localized infections affecting mostly intertriginous sites including the underarms, groin, and buttocks.

The GESUS study is funded by the Danish Agency for Science, Technology and Innovation. Dr. Miller reported having no financial conflicts. The German study was unsponsored.

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

PRAGUE – Off-label use of oral finasteride at 5 mg/day proved safe and effective for the treatment of female pattern hair loss in 43 premenopausal women in an 18-month study.

Treatment effectiveness was assessed in two ways: patient satisfaction scores and two blinded investigators’ evaluation of photographs. As a precondition for study participation, patients needed to have normal serum androgen levels, no clinical signs of hyperandrogenism, and no wish to become pregnant ever again. They also had to go on drospirenone/ethinyl estradiol for oral contraception.

At the 6-month mark, 25 patients (58%) characterized their improvement as "huge" and 14 (33%) as moderate; 4 reported no improvement. These results were stable across time, with the women reporting the same results at 12 and 18 months of follow-up.

The investigators’ blinded assessments of patient photos were less generous: They characterized 19 patients (44%) as very improved, 17 as somewhat improved, and 7 as unimproved.

Diminished libido was reported by 8 patients; 4 had transient nausea or headaches, and 4 reported transient metrorrhagia. One patient had elevated liver function test results and was dropped from the study, Dr. Rui Oliveira-Soares said at the annual congress of the European Academy of Dermatology and Venereology.

"None of us are very pleased with the results we’re having with other drugs," Dr. Oliveira-Soares said. "Sometimes they are unsuccessful or have unacceptable adverse effects. Sometimes there is progression of disease despite every drug we use."

It has been known for more than 15 years that finasteride at 1 mg/day is an effective treatment for male pattern hair loss. It is approved for that indication, as well as for benign prostatic hypertrophy at 5 mg/day.

However, investigators found 12 years ago that finasteride at 1 mg/day is ineffective for female pattern hair loss (J. Am. Acad. Dermatol. 2000;43:768-76). And there have been conflicting reports as to whether the therapy is effective in female androgenetic alopecia at 2.5 mg/day, noted Dr. Oliveira-Soares of Hospital Cuf Descobertas in Lisbon.

Having recently shown in an as-yet-unpublished study that finasteride at a dosage of 5 mg/day was beneficial in postmenopausal women with androgenetic alopecia, Dr. Oliveira-Soares said he sought to learn whether this regimen was safe and effective in premenopausal women affected by the disorder. He reported on 43 patients treated with finasteride at 5 mg/day for 18 months, with formal outcome assessments conducted every 6 months.

Future studies should focus on how to identify likely nonresponders. Also, an 18-month study is not sufficient to draw solid conclusions about the possible long-term risks of extended therapy. An increased risk of breast cancer is a theoretic concern, although there are no clinical data to suggest it is an issue, he said.

The problem in conducting larger, longer-term studies of finasteride at 5 mg/day for female pattern hair loss is that because the drug is available as a relatively inexpensive generic, there is no industry interest in funding such research, he added.

Topical 2% minoxidil is the standard treatment for female pattern hair loss. Among the other drugs used are flutamide and spironolactone, which can have hepatic toxicity, and cyproterone acetate, which can have cardiovascular side effects.

Dr. Oliveira-Soares’ study was supported by hospital research funds. He reported having no relevant financial conflicts.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

PRAGUE – Once-daily brimonidine tartrate gel 0.5% for the treatment of moderate to severe facial erythema of rosacea hit its efficacy and safety end points in a pivotal phase III clinical trial.

The randomized, double-blind, vehicle-controlled, multicenter study totaled 260 patients with persistent moderate to severe facial redness from rosacea. The patients were randomized to once-daily brimonidine tartrate gel 0.5% or a vehicle gel for 4 weeks, with 4 weeks of subsequent off-label follow-up.

The proprietary brimonidine tartrate gel proved faster acting and significantly more effective than the vehicle. Thirty minutes after the first application on study day 1, 28% of patients in the active treatment arm showed at least a 1-grade improvement on both Patient Self-Assessment and Clinician’s Erythema Assessment, compared with 7% of controls, Dr. Y. May Ma reported at the annual congress of the European Academy of Dermatology and Venereology.

The other efficacy end point was maintenance of a 2-grade improvement on both study measures for 12 hours after application on day 29. This was achieved in 23% of patients in the brimonidine tartrate gel cohort and 8% of controls.

No tachyphylaxis or rebound worsening of erythema occurred during the off-treatment follow-up, nor did the brimonidine tartrate group experience aggravation of telangiectasias or inflammatory lesions during that phase of the study, according to Dr. Ma of Galderma Laboratories, Sophia Antipolis, France.

The adverse events were generally mild, transient, and local. The most frequent events in the brimonidine tartrate group were worsening erythema and/or flushing in seven patients, itching in four, and skin irritation in three. No changes in blood pressure or heart rate were noted.

At present no medical therapies are approved for the treatment of persistent facial redness of rosacea. While brimonidine tartrate gel doesn’t tackle the underlying cause of rosacea, the topical vasoconstrictor does improve the appearance of rosacea patients who have persistent erythema. Galderma is preparing to file for U.S. and European marketing approval of the topical agent.

The trial was sponsored by Galderma Laboratories and presented by Dr. Ma, a company employee.

LONDON – Occipital nerve blocks are an effective, safe, and well-tolerated therapy in patients with exacerbation of chronic or episodic cluster headache, according to two observational studies presented at the European Headache and Migraine Trust International Congress.

"It’s a treatment that can suppress attacks temporarily or reduce pain intensity in a high percentage of patients. From the clinical point of view, we gain 1 or 2 or 3 weeks of time to titrate up the standard medications so they can take effect. The patients are attack-free for some days, and they like that very much," observed Dr. Charly Gaul of University Hospital in Essen, Germany.

At the congress, he presented a prospective study of occipital nerve blocks in 101 patients with intractable, disabling cluster headaches insufficiently controlled by the established preventive and acute medications. Sixty-one patients had episodic cluster headache; the other 40 had the less commonly encountered chronic cluster headache, characterized by multiple daily excruciating attacks with no or only brief remission periods.

All subjects received a single occipital nerve block (ONB) of the greater and lesser occipital nerve using 10 mg of triamcinolone along with bupivacaine 0.5% for local anesthesia. The patients completed a headache questionnaire prior to and again 3 and 10 days after receiving the ONB and then once more upon recurrence of their headache attacks.

A total of 83% of patients demonstrated a complete or partial response to their ONB. Efficacy was greater in the episodic cluster headache cohort: 41 of the 61 such patients became completely or temporarily attack free for a mean of 34 days, as did 20 of 40 patients with chronic cluster headache, for a notably briefer mean of 14 days.

Headache frequency in the episodic cluster headache group fell from a mean of 2.9 attacks/day at baseline to 0.7 attacks/day during the first 3 days following ONB and 1.1/day on days 7-10 post treatment. Self-reported pain intensity of attacks on a 0-10 scale improved from 8.4 at baseline to 2.3 in the first several days post-treatment and 3.3 on days 7-10 following the injection.

The average number of headaches per day in the chronic cluster headache cohort dropped from 3.3 at baseline to 1.1 during days 1-3 and 1.9 on days 7-10 post treatment. Pain intensity scores fell from a baseline of 7.9 to 3.9 shortly after ONB and 5.9 on days 7-10 post treatment, Dr. Gaul continued.

Adverse events (all minor) occurred in 11% of patients, the most common of which was a non–cluster headache, occurring in 3% of participants. Injection site pain and occipital muscle tension were among the other adverse events. No severe adverse events occurred.

Questions about ONB therapy that still remain to be answered in future controlled studies include the most efficient dose, the optimal number of injections, whether they should be administered uni- or bilaterally, and the type of steroids that work best. It seems that at present everyone working in this field is using a different injection concoction, the neurologist noted.

In a separate presentation at the congress, Dr. Norazah Abu Bakar of the National Hospital for Neurology and Neurosurgery, London, reported on 83 patients with chronic cluster headache treated with up to three unilateral ONB injections given at 3-month intervals at that institution.

The impetus for this retrospective study focusing on patients with refractory chronic cluster headache, she explained, was that while a recent noteworthy French randomized, double-blind, placebo-controlled clinical trial has shown ONB to be an effective therapy in patients with episodic cluster headache (Lancet Neurol. 2011;10:891-7), that study included only 15 patients with chronic cluster headache. Thus, few data are available on ONB in the 10% or so of cluster headache patients saddled with the extremely burdensome chronic cluster headache.

The ONB used in her study entailed a unilateral injection of a mixture of 80 mg of methylprednisolone and 2 mL of lidocaine 2%. Thirty of the 83 patients (36%) responded to a first injection with a complete pain-free interval lasting for a median of 14 days. Another 29 had partial pain relief, defined as greater than 50% improvement, lasting an average of 18 days. There were 19 nonresponders, and 5 patients experienced deterioration lasting for a median of 14 days.

Mean headache frequency in the overall group improved from 4.2 attacks/day at baseline to 1.7/day post treatment. Self-rated pain intensity went from a mean of 9.5 to 3.9 on a 10-point scale. And there was a further benefit: mean attack duration dropped from 108 minutes to 52 minutes.

The median latency period for a favorable response or headache worsening was 1 day after the injection. Patients reported no serious adverse events following treatment. One-third of subjects reported mild adverse events, mostly self-limited tenderness at the injection site, neck stiffness, and dizziness. No cutaneous atrophy or alopecia occurred after the injection.

Responders to the first injection were offered a second after 3 months, an interval chosen to minimize the risk of side effects due to overexposure to steroids. Among 45 patients treated a second time, 19 had a complete response and 16 a partial response with greater than 50% improvement. The median response duration was 18 days.

Three months later, 28 patients had a third ONB. Eleven showed a complete response and nine were partial responders, with a median response duration of 25 days.

Fourteen patients received a fourth injection, resulting in complete response in seven and partial response in three. The response duration averaged 23 days.

"Given the good tolerability profile when this simple procedure is performed every 3 months, occipital nerve blocks can play a useful role in the management of chronic cluster headache, allowing for periods of relief from an otherwise highly disabling disorder," she concluded.

Cluster headache is a rare disorder characterized by attacks of unilateral pain, typically orbital, supraorbital, and/or temporal. The attacks generally last from 15 minutes to 3 hours. They occur with a frequency ranging from once every day or 2 up to eight per day. Episodic cluster headache occurs in skeins running for weeks to months, followed by remission periods that can last for months.

Dr. Gaul and Dr. Abu Bakar reported having no financial conflicts.

LONDON – Occipital nerve blocks are an effective, safe, and well-tolerated therapy in patients with exacerbation of chronic or episodic cluster headache, according to two observational studies presented at the European Headache and Migraine Trust International Congress.

"It’s a treatment that can suppress attacks temporarily or reduce pain intensity in a high percentage of patients. From the clinical point of view, we gain 1 or 2 or 3 weeks of time to titrate up the standard medications so they can take effect. The patients are attack-free for some days, and they like that very much," observed Dr. Charly Gaul of University Hospital in Essen, Germany.

At the congress, he presented a prospective study of occipital nerve blocks in 101 patients with intractable, disabling cluster headaches insufficiently controlled by the established preventive and acute medications. Sixty-one patients had episodic cluster headache; the other 40 had the less commonly encountered chronic cluster headache, characterized by multiple daily excruciating attacks with no or only brief remission periods.

All subjects received a single occipital nerve block (ONB) of the greater and lesser occipital nerve using 10 mg of triamcinolone along with bupivacaine 0.5% for local anesthesia. The patients completed a headache questionnaire prior to and again 3 and 10 days after receiving the ONB and then once more upon recurrence of their headache attacks.

A total of 83% of patients demonstrated a complete or partial response to their ONB. Efficacy was greater in the episodic cluster headache cohort: 41 of the 61 such patients became completely or temporarily attack free for a mean of 34 days, as did 20 of 40 patients with chronic cluster headache, for a notably briefer mean of 14 days.

Headache frequency in the episodic cluster headache group fell from a mean of 2.9 attacks/day at baseline to 0.7 attacks/day during the first 3 days following ONB and 1.1/day on days 7-10 post treatment. Self-reported pain intensity of attacks on a 0-10 scale improved from 8.4 at baseline to 2.3 in the first several days post-treatment and 3.3 on days 7-10 following the injection.

The average number of headaches per day in the chronic cluster headache cohort dropped from 3.3 at baseline to 1.1 during days 1-3 and 1.9 on days 7-10 post treatment. Pain intensity scores fell from a baseline of 7.9 to 3.9 shortly after ONB and 5.9 on days 7-10 post treatment, Dr. Gaul continued.

Adverse events (all minor) occurred in 11% of patients, the most common of which was a non–cluster headache, occurring in 3% of participants. Injection site pain and occipital muscle tension were among the other adverse events. No severe adverse events occurred.

Questions about ONB therapy that still remain to be answered in future controlled studies include the most efficient dose, the optimal number of injections, whether they should be administered uni- or bilaterally, and the type of steroids that work best. It seems that at present everyone working in this field is using a different injection concoction, the neurologist noted.

In a separate presentation at the congress, Dr. Norazah Abu Bakar of the National Hospital for Neurology and Neurosurgery, London, reported on 83 patients with chronic cluster headache treated with up to three unilateral ONB injections given at 3-month intervals at that institution.

The impetus for this retrospective study focusing on patients with refractory chronic cluster headache, she explained, was that while a recent noteworthy French randomized, double-blind, placebo-controlled clinical trial has shown ONB to be an effective therapy in patients with episodic cluster headache (Lancet Neurol. 2011;10:891-7), that study included only 15 patients with chronic cluster headache. Thus, few data are available on ONB in the 10% or so of cluster headache patients saddled with the extremely burdensome chronic cluster headache.

The ONB used in her study entailed a unilateral injection of a mixture of 80 mg of methylprednisolone and 2 mL of lidocaine 2%. Thirty of the 83 patients (36%) responded to a first injection with a complete pain-free interval lasting for a median of 14 days. Another 29 had partial pain relief, defined as greater than 50% improvement, lasting an average of 18 days. There were 19 nonresponders, and 5 patients experienced deterioration lasting for a median of 14 days.

Mean headache frequency in the overall group improved from 4.2 attacks/day at baseline to 1.7/day post treatment. Self-rated pain intensity went from a mean of 9.5 to 3.9 on a 10-point scale. And there was a further benefit: mean attack duration dropped from 108 minutes to 52 minutes.

The median latency period for a favorable response or headache worsening was 1 day after the injection. Patients reported no serious adverse events following treatment. One-third of subjects reported mild adverse events, mostly self-limited tenderness at the injection site, neck stiffness, and dizziness. No cutaneous atrophy or alopecia occurred after the injection.

Responders to the first injection were offered a second after 3 months, an interval chosen to minimize the risk of side effects due to overexposure to steroids. Among 45 patients treated a second time, 19 had a complete response and 16 a partial response with greater than 50% improvement. The median response duration was 18 days.

Three months later, 28 patients had a third ONB. Eleven showed a complete response and nine were partial responders, with a median response duration of 25 days.

Fourteen patients received a fourth injection, resulting in complete response in seven and partial response in three. The response duration averaged 23 days.

"Given the good tolerability profile when this simple procedure is performed every 3 months, occipital nerve blocks can play a useful role in the management of chronic cluster headache, allowing for periods of relief from an otherwise highly disabling disorder," she concluded.

Cluster headache is a rare disorder characterized by attacks of unilateral pain, typically orbital, supraorbital, and/or temporal. The attacks generally last from 15 minutes to 3 hours. They occur with a frequency ranging from once every day or 2 up to eight per day. Episodic cluster headache occurs in skeins running for weeks to months, followed by remission periods that can last for months.

Dr. Gaul and Dr. Abu Bakar reported having no financial conflicts.

LONDON – Occipital nerve blocks are an effective, safe, and well-tolerated therapy in patients with exacerbation of chronic or episodic cluster headache, according to two observational studies presented at the European Headache and Migraine Trust International Congress.

"It’s a treatment that can suppress attacks temporarily or reduce pain intensity in a high percentage of patients. From the clinical point of view, we gain 1 or 2 or 3 weeks of time to titrate up the standard medications so they can take effect. The patients are attack-free for some days, and they like that very much," observed Dr. Charly Gaul of University Hospital in Essen, Germany.

At the congress, he presented a prospective study of occipital nerve blocks in 101 patients with intractable, disabling cluster headaches insufficiently controlled by the established preventive and acute medications. Sixty-one patients had episodic cluster headache; the other 40 had the less commonly encountered chronic cluster headache, characterized by multiple daily excruciating attacks with no or only brief remission periods.

All subjects received a single occipital nerve block (ONB) of the greater and lesser occipital nerve using 10 mg of triamcinolone along with bupivacaine 0.5% for local anesthesia. The patients completed a headache questionnaire prior to and again 3 and 10 days after receiving the ONB and then once more upon recurrence of their headache attacks.

A total of 83% of patients demonstrated a complete or partial response to their ONB. Efficacy was greater in the episodic cluster headache cohort: 41 of the 61 such patients became completely or temporarily attack free for a mean of 34 days, as did 20 of 40 patients with chronic cluster headache, for a notably briefer mean of 14 days.

Headache frequency in the episodic cluster headache group fell from a mean of 2.9 attacks/day at baseline to 0.7 attacks/day during the first 3 days following ONB and 1.1/day on days 7-10 post treatment. Self-reported pain intensity of attacks on a 0-10 scale improved from 8.4 at baseline to 2.3 in the first several days post-treatment and 3.3 on days 7-10 following the injection.

The average number of headaches per day in the chronic cluster headache cohort dropped from 3.3 at baseline to 1.1 during days 1-3 and 1.9 on days 7-10 post treatment. Pain intensity scores fell from a baseline of 7.9 to 3.9 shortly after ONB and 5.9 on days 7-10 post treatment, Dr. Gaul continued.

Adverse events (all minor) occurred in 11% of patients, the most common of which was a non–cluster headache, occurring in 3% of participants. Injection site pain and occipital muscle tension were among the other adverse events. No severe adverse events occurred.

Questions about ONB therapy that still remain to be answered in future controlled studies include the most efficient dose, the optimal number of injections, whether they should be administered uni- or bilaterally, and the type of steroids that work best. It seems that at present everyone working in this field is using a different injection concoction, the neurologist noted.

In a separate presentation at the congress, Dr. Norazah Abu Bakar of the National Hospital for Neurology and Neurosurgery, London, reported on 83 patients with chronic cluster headache treated with up to three unilateral ONB injections given at 3-month intervals at that institution.

The impetus for this retrospective study focusing on patients with refractory chronic cluster headache, she explained, was that while a recent noteworthy French randomized, double-blind, placebo-controlled clinical trial has shown ONB to be an effective therapy in patients with episodic cluster headache (Lancet Neurol. 2011;10:891-7), that study included only 15 patients with chronic cluster headache. Thus, few data are available on ONB in the 10% or so of cluster headache patients saddled with the extremely burdensome chronic cluster headache.

The ONB used in her study entailed a unilateral injection of a mixture of 80 mg of methylprednisolone and 2 mL of lidocaine 2%. Thirty of the 83 patients (36%) responded to a first injection with a complete pain-free interval lasting for a median of 14 days. Another 29 had partial pain relief, defined as greater than 50% improvement, lasting an average of 18 days. There were 19 nonresponders, and 5 patients experienced deterioration lasting for a median of 14 days.

Mean headache frequency in the overall group improved from 4.2 attacks/day at baseline to 1.7/day post treatment. Self-rated pain intensity went from a mean of 9.5 to 3.9 on a 10-point scale. And there was a further benefit: mean attack duration dropped from 108 minutes to 52 minutes.

The median latency period for a favorable response or headache worsening was 1 day after the injection. Patients reported no serious adverse events following treatment. One-third of subjects reported mild adverse events, mostly self-limited tenderness at the injection site, neck stiffness, and dizziness. No cutaneous atrophy or alopecia occurred after the injection.

Responders to the first injection were offered a second after 3 months, an interval chosen to minimize the risk of side effects due to overexposure to steroids. Among 45 patients treated a second time, 19 had a complete response and 16 a partial response with greater than 50% improvement. The median response duration was 18 days.

Three months later, 28 patients had a third ONB. Eleven showed a complete response and nine were partial responders, with a median response duration of 25 days.

Fourteen patients received a fourth injection, resulting in complete response in seven and partial response in three. The response duration averaged 23 days.

"Given the good tolerability profile when this simple procedure is performed every 3 months, occipital nerve blocks can play a useful role in the management of chronic cluster headache, allowing for periods of relief from an otherwise highly disabling disorder," she concluded.

Cluster headache is a rare disorder characterized by attacks of unilateral pain, typically orbital, supraorbital, and/or temporal. The attacks generally last from 15 minutes to 3 hours. They occur with a frequency ranging from once every day or 2 up to eight per day. Episodic cluster headache occurs in skeins running for weeks to months, followed by remission periods that can last for months.

Dr. Gaul and Dr. Abu Bakar reported having no financial conflicts.

LONDON – The use of any form of acute antimigraine medication by patients with episodic migraine – be it single analgesics, combination analgesics, or triptans – exerted a protective effect against developing chronic migraine in a large, prospective, population-based study.

"This effect seems to be stronger for single analgesics and triptans than for combination analgesics," Dr. Zaza Katsarava observed in presenting findings from the German Headache Consortium Study at the European Headache and Migraine Trust International Congress.

He reported on 1,601 study participants with baseline episodic migraine – meaning migraine headaches on an average of not more than 14 days per month – who were prospectively followed for 2 years. None were on any form of prophylactic pain medication. The goal was to learn whether use of acute antimigraine medication to abort attacks predisposes patients over time to what has been termed "migraine chronification," or the conversion of episodic migraine into even more disabling and burdensome chronic headache, which in this study was defined as any type of headache occurring 15 or more days per month. There has been controversy regarding whether combination analgesics in particular might have such an unwanted effect.

"The purpose of our study is to learn whether general use of one of these classes of substances is associated with higher risk, in which case we would no longer advise their use in our patients," explained Dr. Katsarava, a neurologist at the University of Essen (Germany).

The answer proved reassuring. During 2 years of follow-up, 6.2% of patients with episodic migraine at baseline developed chronic headache. Compared with the 151 subjects who didn’t use any acute antimigraine medication, those who used single analgesics for that purpose had an adjusted 61% lower risk of progressing to chronic headache. Patients who used triptans had a 66% reduction in risk, and those who utilized combination analgesics had a 40% risk reduction, compared with no intake of acute antimigraine medication. This analysis was adjusted for age, sex, body mass index, education level, and baseline migraine frequency.

The protective effect was significantly greater with single analgesic medications as compared to combination analgesics, as reflected in a 35% lower associated relative risk of conversion to chronic headache.

Several audience members tried to argue that perhaps patients who take only single analgesics for acute antimigraine therapy have less severe migraine attacks than do those needing combination analgesics, and that it’s their lesser severity of migraine episodes rather than their use of single analgesics that renders them less likely to develop chronic headache. But Dr. Katsarava was having none of that.

"It’s the right thing to ask. It’s the argument that the pharmaceutical companies manufacturing combination analgesics make. But headache intensity has never been shown to be a risk factor for developing chronic headache; there is no scientific evidence for that. We know that what counts is the frequency of attacks, and we controlled for that," he countered.

Dr. Katsarava emphasized that this wasn’t a study focused on overuse of migraine abortive medications, which is already known to be an important contributor to headache chronification. Instead, the analysis included both normal users of acute antimigraine medications as prescribed and overusers.

The German Headache Consortium Study is funded by the German Federal Ministry of Education and Research. Dr. Katsarava reported serving as a consultant to Allergan and a paid speaker on behalf of that company as well as Merck Serono, Bayer Schering, Biogen, and St. Jude Medical.

LONDON – The use of any form of acute antimigraine medication by patients with episodic migraine – be it single analgesics, combination analgesics, or triptans – exerted a protective effect against developing chronic migraine in a large, prospective, population-based study.

"This effect seems to be stronger for single analgesics and triptans than for combination analgesics," Dr. Zaza Katsarava observed in presenting findings from the German Headache Consortium Study at the European Headache and Migraine Trust International Congress.

He reported on 1,601 study participants with baseline episodic migraine – meaning migraine headaches on an average of not more than 14 days per month – who were prospectively followed for 2 years. None were on any form of prophylactic pain medication. The goal was to learn whether use of acute antimigraine medication to abort attacks predisposes patients over time to what has been termed "migraine chronification," or the conversion of episodic migraine into even more disabling and burdensome chronic headache, which in this study was defined as any type of headache occurring 15 or more days per month. There has been controversy regarding whether combination analgesics in particular might have such an unwanted effect.

"The purpose of our study is to learn whether general use of one of these classes of substances is associated with higher risk, in which case we would no longer advise their use in our patients," explained Dr. Katsarava, a neurologist at the University of Essen (Germany).

The answer proved reassuring. During 2 years of follow-up, 6.2% of patients with episodic migraine at baseline developed chronic headache. Compared with the 151 subjects who didn’t use any acute antimigraine medication, those who used single analgesics for that purpose had an adjusted 61% lower risk of progressing to chronic headache. Patients who used triptans had a 66% reduction in risk, and those who utilized combination analgesics had a 40% risk reduction, compared with no intake of acute antimigraine medication. This analysis was adjusted for age, sex, body mass index, education level, and baseline migraine frequency.

The protective effect was significantly greater with single analgesic medications as compared to combination analgesics, as reflected in a 35% lower associated relative risk of conversion to chronic headache.

Several audience members tried to argue that perhaps patients who take only single analgesics for acute antimigraine therapy have less severe migraine attacks than do those needing combination analgesics, and that it’s their lesser severity of migraine episodes rather than their use of single analgesics that renders them less likely to develop chronic headache. But Dr. Katsarava was having none of that.

"It’s the right thing to ask. It’s the argument that the pharmaceutical companies manufacturing combination analgesics make. But headache intensity has never been shown to be a risk factor for developing chronic headache; there is no scientific evidence for that. We know that what counts is the frequency of attacks, and we controlled for that," he countered.

Dr. Katsarava emphasized that this wasn’t a study focused on overuse of migraine abortive medications, which is already known to be an important contributor to headache chronification. Instead, the analysis included both normal users of acute antimigraine medications as prescribed and overusers.

The German Headache Consortium Study is funded by the German Federal Ministry of Education and Research. Dr. Katsarava reported serving as a consultant to Allergan and a paid speaker on behalf of that company as well as Merck Serono, Bayer Schering, Biogen, and St. Jude Medical.

LONDON – The use of any form of acute antimigraine medication by patients with episodic migraine – be it single analgesics, combination analgesics, or triptans – exerted a protective effect against developing chronic migraine in a large, prospective, population-based study.

"This effect seems to be stronger for single analgesics and triptans than for combination analgesics," Dr. Zaza Katsarava observed in presenting findings from the German Headache Consortium Study at the European Headache and Migraine Trust International Congress.

He reported on 1,601 study participants with baseline episodic migraine – meaning migraine headaches on an average of not more than 14 days per month – who were prospectively followed for 2 years. None were on any form of prophylactic pain medication. The goal was to learn whether use of acute antimigraine medication to abort attacks predisposes patients over time to what has been termed "migraine chronification," or the conversion of episodic migraine into even more disabling and burdensome chronic headache, which in this study was defined as any type of headache occurring 15 or more days per month. There has been controversy regarding whether combination analgesics in particular might have such an unwanted effect.

"The purpose of our study is to learn whether general use of one of these classes of substances is associated with higher risk, in which case we would no longer advise their use in our patients," explained Dr. Katsarava, a neurologist at the University of Essen (Germany).

The answer proved reassuring. During 2 years of follow-up, 6.2% of patients with episodic migraine at baseline developed chronic headache. Compared with the 151 subjects who didn’t use any acute antimigraine medication, those who used single analgesics for that purpose had an adjusted 61% lower risk of progressing to chronic headache. Patients who used triptans had a 66% reduction in risk, and those who utilized combination analgesics had a 40% risk reduction, compared with no intake of acute antimigraine medication. This analysis was adjusted for age, sex, body mass index, education level, and baseline migraine frequency.

The protective effect was significantly greater with single analgesic medications as compared to combination analgesics, as reflected in a 35% lower associated relative risk of conversion to chronic headache.

Several audience members tried to argue that perhaps patients who take only single analgesics for acute antimigraine therapy have less severe migraine attacks than do those needing combination analgesics, and that it’s their lesser severity of migraine episodes rather than their use of single analgesics that renders them less likely to develop chronic headache. But Dr. Katsarava was having none of that.

"It’s the right thing to ask. It’s the argument that the pharmaceutical companies manufacturing combination analgesics make. But headache intensity has never been shown to be a risk factor for developing chronic headache; there is no scientific evidence for that. We know that what counts is the frequency of attacks, and we controlled for that," he countered.

Dr. Katsarava emphasized that this wasn’t a study focused on overuse of migraine abortive medications, which is already known to be an important contributor to headache chronification. Instead, the analysis included both normal users of acute antimigraine medications as prescribed and overusers.

The German Headache Consortium Study is funded by the German Federal Ministry of Education and Research. Dr. Katsarava reported serving as a consultant to Allergan and a paid speaker on behalf of that company as well as Merck Serono, Bayer Schering, Biogen, and St. Jude Medical.