Brian Hoyle

NATIONAL HARBOR, MD. – Delayed-release dimethyl fumarate (DMF) coadministered with norgestimate/ethinyl estradiol, a commonly used progesterone-estrogen combination oral contraceptive, did not alter the OC’s pharmacokinetics or pharmacodynamics, according to the results of a small study.

The safety profile of the coadministered preparation is similar to the profile of DMF (Tecfidera, Biogen) alone, Dr. Bing Zhu said in a poster session at the annual meeting of the Consortium of Multiple Sclerosis Centers.

The findings indicate that women with relapsing-remitting multiple sclerosis (RRMS) who are of childbearing age and who are being treated with DMF can use OCs without having to modify the contraceptive dose, said Dr. Zhu, who is an employee of Biogen, Cambridge, Mass.

The study involved healthy women aged 18-45 years (mean age about 31 years) who were able to conceive. All received a daily OC (Ortho-Cyclen; 250 mcg norgestimate, 35 mcg ethinyl estradiol). After 28 days, those with progesterone levels less than 3 ng/mL were randomized to a 28-day regimen of either the daily dose of OC (n = 39) or OC along with DMF (240 mg twice daily), designated period 1, with crossover to the other treatment for a further 28 days (period 2). Blood samples were collected during the first 24 hours for pharmacokinetic measurements and at 2, 3, and 4 weeks for pharmacodynamic determinations.

The primary objective was the pharmacokinetics of norgestimate, as determined by measuring the levels of its main metabolite, norelgestromin. Secondary objectives included pharmacodynamics, as determined by the levels of serum progesterone and the safety/tolerability of DMF.

©areeya_ann/Thinkstock.com

Plasma concentrations of norelgestromin and ethinyl estradiol were identical over time in the OC and OC + DMF groups in period 1, as was serum progesterone.

Treatment-emergent adverse events were similar in type and severity in both groups. Most were mild. The prevalent adverse events included flushing and gastrointestinal disorders accompanied by nausea and vomiting. Adverse events occurred in 10 of the 39 (26%) subjects who received the OC and in 26 of the 39 (67%) subjects who received the OC + DMF. Discontinuation because of adverse events occurred in 8% and 15% of subjects who received the OC and the OC + DMF, respectively. There were no deaths.

“The results suggest that women of childbearing potential treated with DMF are able to use a combined OC for contraception without dose modification,” said Dr. Zhu.

The study findings were recently published (Neurology. 2016 Apr 5;86:Suppl P2.097).

The study was funded by Biogen. Dr. Zhu is a Biogen employee.

cnnews@frontlinemedcom.com

NATIONAL HARBOR, MD. – Delayed-release dimethyl fumarate (DMF) coadministered with norgestimate/ethinyl estradiol, a commonly used progesterone-estrogen combination oral contraceptive, did not alter the OC’s pharmacokinetics or pharmacodynamics, according to the results of a small study.

The safety profile of the coadministered preparation is similar to the profile of DMF (Tecfidera, Biogen) alone, Dr. Bing Zhu said in a poster session at the annual meeting of the Consortium of Multiple Sclerosis Centers.

The findings indicate that women with relapsing-remitting multiple sclerosis (RRMS) who are of childbearing age and who are being treated with DMF can use OCs without having to modify the contraceptive dose, said Dr. Zhu, who is an employee of Biogen, Cambridge, Mass.

The study involved healthy women aged 18-45 years (mean age about 31 years) who were able to conceive. All received a daily OC (Ortho-Cyclen; 250 mcg norgestimate, 35 mcg ethinyl estradiol). After 28 days, those with progesterone levels less than 3 ng/mL were randomized to a 28-day regimen of either the daily dose of OC (n = 39) or OC along with DMF (240 mg twice daily), designated period 1, with crossover to the other treatment for a further 28 days (period 2). Blood samples were collected during the first 24 hours for pharmacokinetic measurements and at 2, 3, and 4 weeks for pharmacodynamic determinations.

The primary objective was the pharmacokinetics of norgestimate, as determined by measuring the levels of its main metabolite, norelgestromin. Secondary objectives included pharmacodynamics, as determined by the levels of serum progesterone and the safety/tolerability of DMF.

©areeya_ann/Thinkstock.com

Plasma concentrations of norelgestromin and ethinyl estradiol were identical over time in the OC and OC + DMF groups in period 1, as was serum progesterone.

Treatment-emergent adverse events were similar in type and severity in both groups. Most were mild. The prevalent adverse events included flushing and gastrointestinal disorders accompanied by nausea and vomiting. Adverse events occurred in 10 of the 39 (26%) subjects who received the OC and in 26 of the 39 (67%) subjects who received the OC + DMF. Discontinuation because of adverse events occurred in 8% and 15% of subjects who received the OC and the OC + DMF, respectively. There were no deaths.

“The results suggest that women of childbearing potential treated with DMF are able to use a combined OC for contraception without dose modification,” said Dr. Zhu.

The study findings were recently published (Neurology. 2016 Apr 5;86:Suppl P2.097).

The study was funded by Biogen. Dr. Zhu is a Biogen employee.

cnnews@frontlinemedcom.com

NATIONAL HARBOR, MD. – Delayed-release dimethyl fumarate (DMF) coadministered with norgestimate/ethinyl estradiol, a commonly used progesterone-estrogen combination oral contraceptive, did not alter the OC’s pharmacokinetics or pharmacodynamics, according to the results of a small study.

The safety profile of the coadministered preparation is similar to the profile of DMF (Tecfidera, Biogen) alone, Dr. Bing Zhu said in a poster session at the annual meeting of the Consortium of Multiple Sclerosis Centers.

The findings indicate that women with relapsing-remitting multiple sclerosis (RRMS) who are of childbearing age and who are being treated with DMF can use OCs without having to modify the contraceptive dose, said Dr. Zhu, who is an employee of Biogen, Cambridge, Mass.

The study involved healthy women aged 18-45 years (mean age about 31 years) who were able to conceive. All received a daily OC (Ortho-Cyclen; 250 mcg norgestimate, 35 mcg ethinyl estradiol). After 28 days, those with progesterone levels less than 3 ng/mL were randomized to a 28-day regimen of either the daily dose of OC (n = 39) or OC along with DMF (240 mg twice daily), designated period 1, with crossover to the other treatment for a further 28 days (period 2). Blood samples were collected during the first 24 hours for pharmacokinetic measurements and at 2, 3, and 4 weeks for pharmacodynamic determinations.

The primary objective was the pharmacokinetics of norgestimate, as determined by measuring the levels of its main metabolite, norelgestromin. Secondary objectives included pharmacodynamics, as determined by the levels of serum progesterone and the safety/tolerability of DMF.

©areeya_ann/Thinkstock.com

Plasma concentrations of norelgestromin and ethinyl estradiol were identical over time in the OC and OC + DMF groups in period 1, as was serum progesterone.

Treatment-emergent adverse events were similar in type and severity in both groups. Most were mild. The prevalent adverse events included flushing and gastrointestinal disorders accompanied by nausea and vomiting. Adverse events occurred in 10 of the 39 (26%) subjects who received the OC and in 26 of the 39 (67%) subjects who received the OC + DMF. Discontinuation because of adverse events occurred in 8% and 15% of subjects who received the OC and the OC + DMF, respectively. There were no deaths.

“The results suggest that women of childbearing potential treated with DMF are able to use a combined OC for contraception without dose modification,” said Dr. Zhu.

The study findings were recently published (Neurology. 2016 Apr 5;86:Suppl P2.097).

The study was funded by Biogen. Dr. Zhu is a Biogen employee.

cnnews@frontlinemedcom.com

LONDON – Tobacco use and excess weight can make it harder to achieve sustained remission in the treatment of early rheumatoid arthritis, according to findings from more than 1,000 patients in the Canadian Early Arthritis Cohort (CATCH) multicenter, prospective study.

Aggressive treatment that starts soon after diagnosis of rheumatoid arthritis (RA) is important for the absence of disease activity, which is the hallmark of sustained remission. But the reality is a success rate of less than 50% in the first 3 years with physical deterioration continuing thereafter. “Excess weight and smoking are two risk factors for developing RA. We were interested in seeing if they might also affect how well people responded to treatment,” said Susan Bartlett, Ph.D., a clinical psychologist at McGill University in Montreal.

At the annual European Congress of Rheumatology, Dr. Bartlett and colleagues reported on a cohort of 1,008 early RA patients who were enrolled in the Canadian Early Arthritis Cohort (CATCH) multicenter, prospective study and followed from around the time of diagnosis through the first 3 years of treatment to estimate the time it took until they achieved sustained remission, defined as having a 28-joint Disease Activity Score less than 2.6 for two consecutive visits.

Mean age of the patients (72% female, 81% white) was early 50s. Overall, 30% of females and 47% of males were overweight, one-third of both genders were obese, and 15%-20% smoked. Treatment at entry included methotrexate in mono- or combination therapy in about three-quarters of the patients, with steroids used in about half and biologics used sparingly.

The proportion of patients in sustained remission was 38% at 3 years, with a median time to remission of 11.3 months. “That finding wasn’t surprising because that is generally what is found in most studies of early RA. However, when we looked more closely at who was and wasn’t achieving remission, we found that people who smoked and those who were overweight or obese were much less likely than their nonsmoking, normal-weight peers to be in sustained remission,” Dr. Bartlett said in a pre-congress interview.

After adjustment for factors that could affect response to treatment – including age, race, disability status, pain, and early medications used – smoking (P = .046) and excess weight (P = .003) were associated with a poorer likelihood of achieving sustained remission. While more men than women were overweight or obese, the effects of weight and smoking appeared to be more problematic for women (P = .02).

An average nonsmoking male with a healthy body mass index (BMI; 25 kg/m² or less) had about a 41% probability of achieving sustained remission within 3 years, compared with 15% for an obese male smoker. A nonsmoking female with a healthy BMI had a 27% probability of achieving sustained remission within 3 years, compared with 10% for an obese female smoker. Probabilities of sustained remission were also lower for overweight men and women, Dr. Bartlett reported.

Smoking and obesity have already been linked with an increased likelihood of developing RA, which in turn increases the risk of cardiovascular disease and premature death. The latest data suggest that both smoking and extra weight – including overweight and obese as defined by BMI – may also independently influence the success of treatment. “Our data suggest that if you have RA, it’s important to take the medications that your doctor has prescribed. If you smoke, you need to stop. And if you’re carrying extra weight, not only is that placing a greater demand on already vulnerable joints, it may also be making your RA treatment less effective,” Dr. Bartlett said.

These lifestyle modifications can be challenging for some people with RA, she said in the interview. Clinicians can help by considering lifestyle behaviors that lead to chronic diseases and poorer outcomes in addition to their more traditional view of diagnosis and treatment, she said, adding that patients and clinicians should know that even a small amount of weight loss can improve health and may improve response to therapy.

Well controlled clinical trials will be needed to better understand the benefits of weight control and smoking cessation on response to RA treatment. Also, why women who smoke and are overweight are at more of a disadvantage than their male counterparts is unknown. “As we begin putting these pieces together, we may learn valuable information that helps us to better control and ultimately cure RA,” said Dr. Bartlett.

The researchers had no conflicts of interest to declare.

LONDON – Tobacco use and excess weight can make it harder to achieve sustained remission in the treatment of early rheumatoid arthritis, according to findings from more than 1,000 patients in the Canadian Early Arthritis Cohort (CATCH) multicenter, prospective study.

Aggressive treatment that starts soon after diagnosis of rheumatoid arthritis (RA) is important for the absence of disease activity, which is the hallmark of sustained remission. But the reality is a success rate of less than 50% in the first 3 years with physical deterioration continuing thereafter. “Excess weight and smoking are two risk factors for developing RA. We were interested in seeing if they might also affect how well people responded to treatment,” said Susan Bartlett, Ph.D., a clinical psychologist at McGill University in Montreal.

At the annual European Congress of Rheumatology, Dr. Bartlett and colleagues reported on a cohort of 1,008 early RA patients who were enrolled in the Canadian Early Arthritis Cohort (CATCH) multicenter, prospective study and followed from around the time of diagnosis through the first 3 years of treatment to estimate the time it took until they achieved sustained remission, defined as having a 28-joint Disease Activity Score less than 2.6 for two consecutive visits.

Mean age of the patients (72% female, 81% white) was early 50s. Overall, 30% of females and 47% of males were overweight, one-third of both genders were obese, and 15%-20% smoked. Treatment at entry included methotrexate in mono- or combination therapy in about three-quarters of the patients, with steroids used in about half and biologics used sparingly.

The proportion of patients in sustained remission was 38% at 3 years, with a median time to remission of 11.3 months. “That finding wasn’t surprising because that is generally what is found in most studies of early RA. However, when we looked more closely at who was and wasn’t achieving remission, we found that people who smoked and those who were overweight or obese were much less likely than their nonsmoking, normal-weight peers to be in sustained remission,” Dr. Bartlett said in a pre-congress interview.

After adjustment for factors that could affect response to treatment – including age, race, disability status, pain, and early medications used – smoking (P = .046) and excess weight (P = .003) were associated with a poorer likelihood of achieving sustained remission. While more men than women were overweight or obese, the effects of weight and smoking appeared to be more problematic for women (P = .02).

An average nonsmoking male with a healthy body mass index (BMI; 25 kg/m² or less) had about a 41% probability of achieving sustained remission within 3 years, compared with 15% for an obese male smoker. A nonsmoking female with a healthy BMI had a 27% probability of achieving sustained remission within 3 years, compared with 10% for an obese female smoker. Probabilities of sustained remission were also lower for overweight men and women, Dr. Bartlett reported.

Smoking and obesity have already been linked with an increased likelihood of developing RA, which in turn increases the risk of cardiovascular disease and premature death. The latest data suggest that both smoking and extra weight – including overweight and obese as defined by BMI – may also independently influence the success of treatment. “Our data suggest that if you have RA, it’s important to take the medications that your doctor has prescribed. If you smoke, you need to stop. And if you’re carrying extra weight, not only is that placing a greater demand on already vulnerable joints, it may also be making your RA treatment less effective,” Dr. Bartlett said.

These lifestyle modifications can be challenging for some people with RA, she said in the interview. Clinicians can help by considering lifestyle behaviors that lead to chronic diseases and poorer outcomes in addition to their more traditional view of diagnosis and treatment, she said, adding that patients and clinicians should know that even a small amount of weight loss can improve health and may improve response to therapy.

Well controlled clinical trials will be needed to better understand the benefits of weight control and smoking cessation on response to RA treatment. Also, why women who smoke and are overweight are at more of a disadvantage than their male counterparts is unknown. “As we begin putting these pieces together, we may learn valuable information that helps us to better control and ultimately cure RA,” said Dr. Bartlett.

The researchers had no conflicts of interest to declare.

LONDON – Tobacco use and excess weight can make it harder to achieve sustained remission in the treatment of early rheumatoid arthritis, according to findings from more than 1,000 patients in the Canadian Early Arthritis Cohort (CATCH) multicenter, prospective study.

Aggressive treatment that starts soon after diagnosis of rheumatoid arthritis (RA) is important for the absence of disease activity, which is the hallmark of sustained remission. But the reality is a success rate of less than 50% in the first 3 years with physical deterioration continuing thereafter. “Excess weight and smoking are two risk factors for developing RA. We were interested in seeing if they might also affect how well people responded to treatment,” said Susan Bartlett, Ph.D., a clinical psychologist at McGill University in Montreal.

At the annual European Congress of Rheumatology, Dr. Bartlett and colleagues reported on a cohort of 1,008 early RA patients who were enrolled in the Canadian Early Arthritis Cohort (CATCH) multicenter, prospective study and followed from around the time of diagnosis through the first 3 years of treatment to estimate the time it took until they achieved sustained remission, defined as having a 28-joint Disease Activity Score less than 2.6 for two consecutive visits.

Mean age of the patients (72% female, 81% white) was early 50s. Overall, 30% of females and 47% of males were overweight, one-third of both genders were obese, and 15%-20% smoked. Treatment at entry included methotrexate in mono- or combination therapy in about three-quarters of the patients, with steroids used in about half and biologics used sparingly.

The proportion of patients in sustained remission was 38% at 3 years, with a median time to remission of 11.3 months. “That finding wasn’t surprising because that is generally what is found in most studies of early RA. However, when we looked more closely at who was and wasn’t achieving remission, we found that people who smoked and those who were overweight or obese were much less likely than their nonsmoking, normal-weight peers to be in sustained remission,” Dr. Bartlett said in a pre-congress interview.

After adjustment for factors that could affect response to treatment – including age, race, disability status, pain, and early medications used – smoking (P = .046) and excess weight (P = .003) were associated with a poorer likelihood of achieving sustained remission. While more men than women were overweight or obese, the effects of weight and smoking appeared to be more problematic for women (P = .02).

An average nonsmoking male with a healthy body mass index (BMI; 25 kg/m² or less) had about a 41% probability of achieving sustained remission within 3 years, compared with 15% for an obese male smoker. A nonsmoking female with a healthy BMI had a 27% probability of achieving sustained remission within 3 years, compared with 10% for an obese female smoker. Probabilities of sustained remission were also lower for overweight men and women, Dr. Bartlett reported.

Smoking and obesity have already been linked with an increased likelihood of developing RA, which in turn increases the risk of cardiovascular disease and premature death. The latest data suggest that both smoking and extra weight – including overweight and obese as defined by BMI – may also independently influence the success of treatment. “Our data suggest that if you have RA, it’s important to take the medications that your doctor has prescribed. If you smoke, you need to stop. And if you’re carrying extra weight, not only is that placing a greater demand on already vulnerable joints, it may also be making your RA treatment less effective,” Dr. Bartlett said.

These lifestyle modifications can be challenging for some people with RA, she said in the interview. Clinicians can help by considering lifestyle behaviors that lead to chronic diseases and poorer outcomes in addition to their more traditional view of diagnosis and treatment, she said, adding that patients and clinicians should know that even a small amount of weight loss can improve health and may improve response to therapy.

Well controlled clinical trials will be needed to better understand the benefits of weight control and smoking cessation on response to RA treatment. Also, why women who smoke and are overweight are at more of a disadvantage than their male counterparts is unknown. “As we begin putting these pieces together, we may learn valuable information that helps us to better control and ultimately cure RA,” said Dr. Bartlett.

The researchers had no conflicts of interest to declare.

NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.

The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.

The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.

The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.

Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.

The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.

The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.

“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.

Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.

The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.

NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.

The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.

The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.

The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.

Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.

The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.

The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.

“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.

Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.

The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.

NATIONAL HARBOR, MD. – The approved once-daily oral immunomodulator teriflunomide is effective in reducing relapse, and worsening of relapsing forms, of multiple sclerosis (RMS) in patients with faster-advancing disease.

The findings from a post hoc pooled subgroup analysis of patients in the TEMSO and TOWER randomized, double-blind, placebo-controlled phase III trials presented as a poster at the annual meeting of the Consortium of Multiple Sclerosis Centers expand the efficacy of teriflunomide to a broad spectrum of patients with RMS.

The pooled analysis examined the outcomes of treatment with two doses of teriflunomide in all patients (n = 2,257) and in a subgroup of patients with faster-advancing MS (n = 1,184) according to disease severity using a baseline Multiple Sclerosis Severity Score (MSSS) of 5 as a cutoff. The group with faster-advancing disease included 405 who received placebo, 396 treated with teriflunomide 7 mg, and 383 treated with teriflunomide 14 mg.

The 1,184 patients with faster-advancing MS were comparable to the other 1,073 patients in terms of age, sex, MS subtype, and number of relapses in the prior year. Baseline characteristics of the faster-advancing MS patients treated with placebo and both teriflunomide doses were comparable.

Relative to the placebo group, the annualized relapse rate in patients with faster-advancing MS was significantly reduced by both doses of teriflunomide, with a relative risk reduction of 30.3% for the 7-mg dose (P = .0002) and 37.5% for the 14-mg dose (P less than .0001). Time to first relapse was also reduced by teriflunomide 14 mg and 7 mg, with reductions in relapse risk of 43.2% (P less than .0001) and 28.8% (P = .0014), respectively, compared with placebo.

The higher dose of teriflunomide was effective in reducing the worsening of disability at greater than or equal to 12 weeks and 24 weeks, with reductions, compared with placebo, of 40.3% (P = .0076) and 46.1% (P = .0110), respectively.

The results were consistent with data reported in the individual TEMSO and TOWER trials, and prior analyses of the pooled data.

“These results indicate that teriflunomide is not only effective for MS patients with relatively mild disease, but also with rather more aggressive disease. Teriflunomide, a well-tolerated and convenient once-daily tablet, is a very reasonable option for this population,” said the presenter, Dr. Aaron E. Miller of the Icahn School of Medicine at Mount Sinai, New York.

Teriflunomide is approved for relapsing-remitting MS in many countries, including the United States and the European Union. The TEMSO and TOWER trials were pivotal in securing approval. The trials had a similar design, except for the absence of magnetic resonance imaging evaluation in TOWER.

The study was funded by Sanofi Genzyme. Dr. Miller disclosed consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, Mallinckrodt Paharmaceuticals/Questor, Novartis, Roche, and Teva, and grant/research support from Biogen, Genentech, Novartis, Questor, Roche, and Sanofi.

NATIONAL HARBOR, MD. – Follow-up of a cohort of patients in the United Kingdom has demonstrated associations between smoking and a higher risk of development of multiple sclerosis (MS), progression of MS-related disability, higher risk of premature death, and shortened life expectancy.

The findings highlight the need for clinical trials of the effects of quitting smoking and provide data that will be useful in the development of effective intervention strategies.

Dr. Cris S. Constantinescu of the University of Nottingham (England) discussed findings from the Nottingham University Hospitals MS Clinics database at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Although smokers had higher levels of comorbid conditions, it appeared that the influence of smoking is independent of the presence of comorbid conditions. Those who gave up smoking could do as well as nonsmokers,” said Dr. Constantinescu.

While ample epidemiologic evidence indicates that smoking is a driver of the development and progression of MS, there are few hard data. To gain insight, the researchers analyzed data on over 1,200 MS patients throughout England who were followed up beginning in the mid-1990s. About 60% of the patients had relapsing-remitting MS. The duration of MS and smoking were both about 20 years. About 60% of men and 50% of women were current smokers.

Regular smokers were 64% more likely to develop MS than were nonsmokers. Having ever smoked carried a 44% increased risk of MS (both P less than .001). MS patients who grew up in a household where one parent smoked were 50% more likely to become regular smokers. The risk climbed to 85% if both parents were smokers.

No association was evident between smoking and the development of primary progressive MS, but current smokers were almost 2.5 times more likely to develop secondary progressive MS. Smoking correlated with more severe MS disability, compared with nonsmokers. Ex-smokers had risks similar to those of nonsmokers of developing secondary MS and in the level of disease severity.

Every year a person refrained from smoking decreased the risk of severe disability by 5%. Current and ex-smokers displayed increased psychological and physical detriments of MS.

In a subgroup of 923 patients, of whom 80 died, current smokers were almost 3 times and 1.5 times more likely to die, compared with never smokers and ex-smokers, respectively, and were twice as likely to die as were people without MS in the UK general population.

The findings have prompted studies into major aspects of smoking, such as the age when smoking begins, the success of various smoking cessation programs, and development of interventions. Some of the data discussed at the meeting were published in 2013 (Brain;136:2298-2304) and some are part of a manuscript in preparation.

NATIONAL HARBOR, MD. – Follow-up of a cohort of patients in the United Kingdom has demonstrated associations between smoking and a higher risk of development of multiple sclerosis (MS), progression of MS-related disability, higher risk of premature death, and shortened life expectancy.

The findings highlight the need for clinical trials of the effects of quitting smoking and provide data that will be useful in the development of effective intervention strategies.

Dr. Cris S. Constantinescu of the University of Nottingham (England) discussed findings from the Nottingham University Hospitals MS Clinics database at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Although smokers had higher levels of comorbid conditions, it appeared that the influence of smoking is independent of the presence of comorbid conditions. Those who gave up smoking could do as well as nonsmokers,” said Dr. Constantinescu.

While ample epidemiologic evidence indicates that smoking is a driver of the development and progression of MS, there are few hard data. To gain insight, the researchers analyzed data on over 1,200 MS patients throughout England who were followed up beginning in the mid-1990s. About 60% of the patients had relapsing-remitting MS. The duration of MS and smoking were both about 20 years. About 60% of men and 50% of women were current smokers.

Regular smokers were 64% more likely to develop MS than were nonsmokers. Having ever smoked carried a 44% increased risk of MS (both P less than .001). MS patients who grew up in a household where one parent smoked were 50% more likely to become regular smokers. The risk climbed to 85% if both parents were smokers.

No association was evident between smoking and the development of primary progressive MS, but current smokers were almost 2.5 times more likely to develop secondary progressive MS. Smoking correlated with more severe MS disability, compared with nonsmokers. Ex-smokers had risks similar to those of nonsmokers of developing secondary MS and in the level of disease severity.

Every year a person refrained from smoking decreased the risk of severe disability by 5%. Current and ex-smokers displayed increased psychological and physical detriments of MS.

In a subgroup of 923 patients, of whom 80 died, current smokers were almost 3 times and 1.5 times more likely to die, compared with never smokers and ex-smokers, respectively, and were twice as likely to die as were people without MS in the UK general population.

The findings have prompted studies into major aspects of smoking, such as the age when smoking begins, the success of various smoking cessation programs, and development of interventions. Some of the data discussed at the meeting were published in 2013 (Brain;136:2298-2304) and some are part of a manuscript in preparation.

NATIONAL HARBOR, MD. – Follow-up of a cohort of patients in the United Kingdom has demonstrated associations between smoking and a higher risk of development of multiple sclerosis (MS), progression of MS-related disability, higher risk of premature death, and shortened life expectancy.

The findings highlight the need for clinical trials of the effects of quitting smoking and provide data that will be useful in the development of effective intervention strategies.

Dr. Cris S. Constantinescu of the University of Nottingham (England) discussed findings from the Nottingham University Hospitals MS Clinics database at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“Although smokers had higher levels of comorbid conditions, it appeared that the influence of smoking is independent of the presence of comorbid conditions. Those who gave up smoking could do as well as nonsmokers,” said Dr. Constantinescu.

While ample epidemiologic evidence indicates that smoking is a driver of the development and progression of MS, there are few hard data. To gain insight, the researchers analyzed data on over 1,200 MS patients throughout England who were followed up beginning in the mid-1990s. About 60% of the patients had relapsing-remitting MS. The duration of MS and smoking were both about 20 years. About 60% of men and 50% of women were current smokers.

Regular smokers were 64% more likely to develop MS than were nonsmokers. Having ever smoked carried a 44% increased risk of MS (both P less than .001). MS patients who grew up in a household where one parent smoked were 50% more likely to become regular smokers. The risk climbed to 85% if both parents were smokers.

No association was evident between smoking and the development of primary progressive MS, but current smokers were almost 2.5 times more likely to develop secondary progressive MS. Smoking correlated with more severe MS disability, compared with nonsmokers. Ex-smokers had risks similar to those of nonsmokers of developing secondary MS and in the level of disease severity.

Every year a person refrained from smoking decreased the risk of severe disability by 5%. Current and ex-smokers displayed increased psychological and physical detriments of MS.

In a subgroup of 923 patients, of whom 80 died, current smokers were almost 3 times and 1.5 times more likely to die, compared with never smokers and ex-smokers, respectively, and were twice as likely to die as were people without MS in the UK general population.

The findings have prompted studies into major aspects of smoking, such as the age when smoking begins, the success of various smoking cessation programs, and development of interventions. Some of the data discussed at the meeting were published in 2013 (Brain;136:2298-2304) and some are part of a manuscript in preparation.

NATIONAL HARBOR, MD. – Updated imaging protocols for patients with multiple sclerosis from a panel of North American neurology and radiology experts promise to improve the accuracy of diagnosis and monitoring.

The guidelines emphasize the use of three-dimensional MRI to provide complete coverage of the brain, monitoring for progressive multifocal leukoencephalopathy (PML), and optical orbit MRI for severe optic neuritis.

Key clinical guideline changes include more specific timing of brain MRI when monitoring patients receiving disease modifying therapy, timing of brain MRI to monitor for PML, updated evidence of the value of MRI changes in determining the effectiveness of treatment, and the inclusion of radiologic isolated syndrome.

Dr. Anthony Traboulsee of the University of British Columbia, Vancouver, discussed the latest MRI guidelines at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS is a life-long disorder and MRI is one of the best ways to monitor for new lesions that can be occurring in the absence of new symptoms (clinically silent disease activity). These lesions accumulate and lead to future disability. In order to accurately determine if changes are occurring, we need MRIs that are similar in quality over time regardless of where the patient had an MRI performed. A standardized MRI protocol provides this quality of data,” Dr. Traboulsee said.

The guidelines, published in the American Journal of Neuroradiology (Am J Neuroradiol. 2015 Nov 12. doi: 10.3174/ajnr.A4539), recommend a first MRI as soon as a physician suspects MS in a patient, with subsequent MRIs typically done annually to determine whether the disease is stable or progressive, which could prompt a change in treatment. “Breakthrough activity on MRI that is occurring while on treatment can lead to future disability and is an opportunity to consider switching therapy,” Dr. Traboulsee said.

More frequent scans could be appropriate for patients with a more aggressive and active disease course, and when treatment has been changed. More frequent monitoring and diffusion-weighted imaging is also recommended for patients taking natalizumab (Tysabri), since they are at high risk for PML.

Another goal of the guidelines is to describe how best to use MRI to support an early diagnosis of MS and to help avoid misdiagnosis. Early treatment depends on an early diagnosis. “We find the biggest impact of our disease-modifying therapy is in the first decade. The goal is to prevent new injury and optimize brain health through treatment and lifestyle,” said Dr. Traboulsee.

MRI scans alone should not be diagnostic. Clinical information is also needed, such as numbness or problems with balance. Abnormal brain MRIs occur in about 5% of people without MS and white spots in the brain that are unrelated to MS can naturally develop as people age.

If clinically isolated syndrome is suspected, a cervical cord MRI should be done along with a brain MRI. Use of a gadolinium contrast agent is recommended to better determine disease activity and speed diagnosis.

Dr. Traboulsee received grant support from Biogen, Chugai, Hoffman la Roche, and Sanofi Genzyme. He reported being a steering committee member for Hoffman la Roche and has been a consultant to Biogen, Chugai, EMD Serono, Hoffman la Roche, MedImmune, Sanofi Genzyme, and Teva Neuroscience.

NATIONAL HARBOR, MD. – Updated imaging protocols for patients with multiple sclerosis from a panel of North American neurology and radiology experts promise to improve the accuracy of diagnosis and monitoring.

The guidelines emphasize the use of three-dimensional MRI to provide complete coverage of the brain, monitoring for progressive multifocal leukoencephalopathy (PML), and optical orbit MRI for severe optic neuritis.

Key clinical guideline changes include more specific timing of brain MRI when monitoring patients receiving disease modifying therapy, timing of brain MRI to monitor for PML, updated evidence of the value of MRI changes in determining the effectiveness of treatment, and the inclusion of radiologic isolated syndrome.

Dr. Anthony Traboulsee of the University of British Columbia, Vancouver, discussed the latest MRI guidelines at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS is a life-long disorder and MRI is one of the best ways to monitor for new lesions that can be occurring in the absence of new symptoms (clinically silent disease activity). These lesions accumulate and lead to future disability. In order to accurately determine if changes are occurring, we need MRIs that are similar in quality over time regardless of where the patient had an MRI performed. A standardized MRI protocol provides this quality of data,” Dr. Traboulsee said.

The guidelines, published in the American Journal of Neuroradiology (Am J Neuroradiol. 2015 Nov 12. doi: 10.3174/ajnr.A4539), recommend a first MRI as soon as a physician suspects MS in a patient, with subsequent MRIs typically done annually to determine whether the disease is stable or progressive, which could prompt a change in treatment. “Breakthrough activity on MRI that is occurring while on treatment can lead to future disability and is an opportunity to consider switching therapy,” Dr. Traboulsee said.

More frequent scans could be appropriate for patients with a more aggressive and active disease course, and when treatment has been changed. More frequent monitoring and diffusion-weighted imaging is also recommended for patients taking natalizumab (Tysabri), since they are at high risk for PML.

Another goal of the guidelines is to describe how best to use MRI to support an early diagnosis of MS and to help avoid misdiagnosis. Early treatment depends on an early diagnosis. “We find the biggest impact of our disease-modifying therapy is in the first decade. The goal is to prevent new injury and optimize brain health through treatment and lifestyle,” said Dr. Traboulsee.

MRI scans alone should not be diagnostic. Clinical information is also needed, such as numbness or problems with balance. Abnormal brain MRIs occur in about 5% of people without MS and white spots in the brain that are unrelated to MS can naturally develop as people age.

If clinically isolated syndrome is suspected, a cervical cord MRI should be done along with a brain MRI. Use of a gadolinium contrast agent is recommended to better determine disease activity and speed diagnosis.

Dr. Traboulsee received grant support from Biogen, Chugai, Hoffman la Roche, and Sanofi Genzyme. He reported being a steering committee member for Hoffman la Roche and has been a consultant to Biogen, Chugai, EMD Serono, Hoffman la Roche, MedImmune, Sanofi Genzyme, and Teva Neuroscience.

NATIONAL HARBOR, MD. – Updated imaging protocols for patients with multiple sclerosis from a panel of North American neurology and radiology experts promise to improve the accuracy of diagnosis and monitoring.

The guidelines emphasize the use of three-dimensional MRI to provide complete coverage of the brain, monitoring for progressive multifocal leukoencephalopathy (PML), and optical orbit MRI for severe optic neuritis.

Key clinical guideline changes include more specific timing of brain MRI when monitoring patients receiving disease modifying therapy, timing of brain MRI to monitor for PML, updated evidence of the value of MRI changes in determining the effectiveness of treatment, and the inclusion of radiologic isolated syndrome.

Dr. Anthony Traboulsee of the University of British Columbia, Vancouver, discussed the latest MRI guidelines at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“MS is a life-long disorder and MRI is one of the best ways to monitor for new lesions that can be occurring in the absence of new symptoms (clinically silent disease activity). These lesions accumulate and lead to future disability. In order to accurately determine if changes are occurring, we need MRIs that are similar in quality over time regardless of where the patient had an MRI performed. A standardized MRI protocol provides this quality of data,” Dr. Traboulsee said.

The guidelines, published in the American Journal of Neuroradiology (Am J Neuroradiol. 2015 Nov 12. doi: 10.3174/ajnr.A4539), recommend a first MRI as soon as a physician suspects MS in a patient, with subsequent MRIs typically done annually to determine whether the disease is stable or progressive, which could prompt a change in treatment. “Breakthrough activity on MRI that is occurring while on treatment can lead to future disability and is an opportunity to consider switching therapy,” Dr. Traboulsee said.

More frequent scans could be appropriate for patients with a more aggressive and active disease course, and when treatment has been changed. More frequent monitoring and diffusion-weighted imaging is also recommended for patients taking natalizumab (Tysabri), since they are at high risk for PML.

Another goal of the guidelines is to describe how best to use MRI to support an early diagnosis of MS and to help avoid misdiagnosis. Early treatment depends on an early diagnosis. “We find the biggest impact of our disease-modifying therapy is in the first decade. The goal is to prevent new injury and optimize brain health through treatment and lifestyle,” said Dr. Traboulsee.

MRI scans alone should not be diagnostic. Clinical information is also needed, such as numbness or problems with balance. Abnormal brain MRIs occur in about 5% of people without MS and white spots in the brain that are unrelated to MS can naturally develop as people age.

If clinically isolated syndrome is suspected, a cervical cord MRI should be done along with a brain MRI. Use of a gadolinium contrast agent is recommended to better determine disease activity and speed diagnosis.

Dr. Traboulsee received grant support from Biogen, Chugai, Hoffman la Roche, and Sanofi Genzyme. He reported being a steering committee member for Hoffman la Roche and has been a consultant to Biogen, Chugai, EMD Serono, Hoffman la Roche, MedImmune, Sanofi Genzyme, and Teva Neuroscience.

BOSTON – An analysis of data from medullary thyroid cancer patients that partitioned the patients into groups with similar overall survival has spurred a rethink of the current American Joint Committee on Cancer (AJCC) staging system.

The results from researchers at Duke University, Durham, N.C., presented at the annual meeting of the Endocrine Society by Dr. Mohamed Abdelgadir Adam, are timely, as the AJCC has embarked on a reconsideration of the staging of cancers, including medullary thyroid cancer (MTC), as part revisions for the eighth edition of the staging system.

“The existing AJCC staging system for MTC appears to be less than optimal in discriminating the risk of mortality among disease stage groups,” said Dr. Adam, who discussed the findings in a video interview.

MTC, a neuroendocrine tumor that affects C cells of the thyroid, comprises 3%-5% of all cases of thyroid cancer and it can be a more aggressive disease than differentiated thyroid cancer. Yet the current AJCC MTC staging system has been extrapolated from differentiated thyroid cancer data.

“We sought to evaluate how well the current AJCC seventh edition stage groupings predict survival for patients with MTC, to suggest a possible staging revision to sharpen estimates of prognosis,” said Dr. Adam.

The researchers utilized the National Cancer Data Base, representing over 70% of incident cancer cases in the United States.

MTC patients who underwent thyroid surgery from 1998 to 2012 were identified. Patients with missing values for pathologic T, N, or M were excluded. The primary outcome in the 3,315 patients was survival.

The researchers used a form of decision-tree analysis called recursive partitioning. In general, recursive partitioning is able to classify a population by splitting subjects into subgroups, each of which is homogeneous based on the particular outcome. In this study, the subgroup allocations were based on T, N, and M stages, with the outcome being overall survival. Kaplan-Meier and adjusted survival analyses enabled survival differences among the four subgroups (groups I, II, III and IV) to be explored.

The four groups were distinct in terms of survival time and allowed more accurate risk stratification. In particular, groups I and II were markedly better distinguished from one another than is the case with the current staging system. Survival differences across the stages were more distinct with the newly created T, N, and M groupings, compared with the current AJCC staging system.

After adjustment, survival differences across TNM groups were more distinct with the newly created TNM groupings (compared to subgroup I, hazard ratio of 3.06 for subgroup II; HR, 6.79 for III; and HR, 17.03 for IV), compared with the current AJCC staging (compared to stage I, HR, 1.45 for stage II; HR, 2.17 for III; and HR, 5.33 for IV).

“The AJCC is reevaluating all staging schemas, including MTC. The current AJCC staging system could be improved with the newly identified TNM groupings suggested here for more accurate patient risk stratification and possibly treatment selection,” said Dr. Adam.

Dr. Adam had no disclosures.

BOSTON – An analysis of data from medullary thyroid cancer patients that partitioned the patients into groups with similar overall survival has spurred a rethink of the current American Joint Committee on Cancer (AJCC) staging system.

The results from researchers at Duke University, Durham, N.C., presented at the annual meeting of the Endocrine Society by Dr. Mohamed Abdelgadir Adam, are timely, as the AJCC has embarked on a reconsideration of the staging of cancers, including medullary thyroid cancer (MTC), as part revisions for the eighth edition of the staging system.

“The existing AJCC staging system for MTC appears to be less than optimal in discriminating the risk of mortality among disease stage groups,” said Dr. Adam, who discussed the findings in a video interview.

MTC, a neuroendocrine tumor that affects C cells of the thyroid, comprises 3%-5% of all cases of thyroid cancer and it can be a more aggressive disease than differentiated thyroid cancer. Yet the current AJCC MTC staging system has been extrapolated from differentiated thyroid cancer data.

“We sought to evaluate how well the current AJCC seventh edition stage groupings predict survival for patients with MTC, to suggest a possible staging revision to sharpen estimates of prognosis,” said Dr. Adam.

The researchers utilized the National Cancer Data Base, representing over 70% of incident cancer cases in the United States.

MTC patients who underwent thyroid surgery from 1998 to 2012 were identified. Patients with missing values for pathologic T, N, or M were excluded. The primary outcome in the 3,315 patients was survival.

The researchers used a form of decision-tree analysis called recursive partitioning. In general, recursive partitioning is able to classify a population by splitting subjects into subgroups, each of which is homogeneous based on the particular outcome. In this study, the subgroup allocations were based on T, N, and M stages, with the outcome being overall survival. Kaplan-Meier and adjusted survival analyses enabled survival differences among the four subgroups (groups I, II, III and IV) to be explored.

The four groups were distinct in terms of survival time and allowed more accurate risk stratification. In particular, groups I and II were markedly better distinguished from one another than is the case with the current staging system. Survival differences across the stages were more distinct with the newly created T, N, and M groupings, compared with the current AJCC staging system.

After adjustment, survival differences across TNM groups were more distinct with the newly created TNM groupings (compared to subgroup I, hazard ratio of 3.06 for subgroup II; HR, 6.79 for III; and HR, 17.03 for IV), compared with the current AJCC staging (compared to stage I, HR, 1.45 for stage II; HR, 2.17 for III; and HR, 5.33 for IV).

“The AJCC is reevaluating all staging schemas, including MTC. The current AJCC staging system could be improved with the newly identified TNM groupings suggested here for more accurate patient risk stratification and possibly treatment selection,” said Dr. Adam.

Dr. Adam had no disclosures.

BOSTON – An analysis of data from medullary thyroid cancer patients that partitioned the patients into groups with similar overall survival has spurred a rethink of the current American Joint Committee on Cancer (AJCC) staging system.

The results from researchers at Duke University, Durham, N.C., presented at the annual meeting of the Endocrine Society by Dr. Mohamed Abdelgadir Adam, are timely, as the AJCC has embarked on a reconsideration of the staging of cancers, including medullary thyroid cancer (MTC), as part revisions for the eighth edition of the staging system.

“The existing AJCC staging system for MTC appears to be less than optimal in discriminating the risk of mortality among disease stage groups,” said Dr. Adam, who discussed the findings in a video interview.

MTC, a neuroendocrine tumor that affects C cells of the thyroid, comprises 3%-5% of all cases of thyroid cancer and it can be a more aggressive disease than differentiated thyroid cancer. Yet the current AJCC MTC staging system has been extrapolated from differentiated thyroid cancer data.

“We sought to evaluate how well the current AJCC seventh edition stage groupings predict survival for patients with MTC, to suggest a possible staging revision to sharpen estimates of prognosis,” said Dr. Adam.

The researchers utilized the National Cancer Data Base, representing over 70% of incident cancer cases in the United States.

MTC patients who underwent thyroid surgery from 1998 to 2012 were identified. Patients with missing values for pathologic T, N, or M were excluded. The primary outcome in the 3,315 patients was survival.

The researchers used a form of decision-tree analysis called recursive partitioning. In general, recursive partitioning is able to classify a population by splitting subjects into subgroups, each of which is homogeneous based on the particular outcome. In this study, the subgroup allocations were based on T, N, and M stages, with the outcome being overall survival. Kaplan-Meier and adjusted survival analyses enabled survival differences among the four subgroups (groups I, II, III and IV) to be explored.

The four groups were distinct in terms of survival time and allowed more accurate risk stratification. In particular, groups I and II were markedly better distinguished from one another than is the case with the current staging system. Survival differences across the stages were more distinct with the newly created T, N, and M groupings, compared with the current AJCC staging system.

After adjustment, survival differences across TNM groups were more distinct with the newly created TNM groupings (compared to subgroup I, hazard ratio of 3.06 for subgroup II; HR, 6.79 for III; and HR, 17.03 for IV), compared with the current AJCC staging (compared to stage I, HR, 1.45 for stage II; HR, 2.17 for III; and HR, 5.33 for IV).

“The AJCC is reevaluating all staging schemas, including MTC. The current AJCC staging system could be improved with the newly identified TNM groupings suggested here for more accurate patient risk stratification and possibly treatment selection,” said Dr. Adam.

Dr. Adam had no disclosures.