Andrew D. Bowser

Patients with malignant pleural effusion treated with an indwelling pleural catheter have an improved chance of a positive outcome when talc administration is part of their procedure, suggest the results of a randomized, placebo-controlled study.

Malignant pleural effusion, which is usually caused by the spread of metastatic cancer, is typically treated by inducement of pleurodesis. Talc is probably the most effective agent for achieving this result, but there are drawbacks to using talc to induce pleurodesis. Patients who receive this treatment often need to stay in the hospital for 4-7 days, according to Rahul Bhatnagar, PhD, and the coauthors of a study published in the New England Journal of Medicine). Indwelling pleural catheters provide an “ambulatory alternative” for fluid management, they noted. In a noncomparative series of 22 patients, administering talc through such a catheter produced high rates of pleurodesis, they added.

In the new study, Dr. Bhatnagar of the Academic Respiratory Unit, University of Bristol, England, and his coauthors evaluated the use of an indwelling catheter, with or without talc, in patients with malignant pleural effusion recruited at 18 centers in the United Kingdom over 4 years.

“Our primary-outcome results, which were backed up by robust sensitivity analyses, strongly suggest that the administration of talc through an indwelling pleural catheter was significantly more efficacious than the use of an indwelling pleural catheter alone among patients without substantial lung entrapment,” the authors wrote.

A total of 154 patients underwent randomization to the talc or placebo group, and 139 had sufficient data to evaluate the primary outcome of successful pleurodesis at 35 days after randomization. The researchers excluded patients with evidence of lung entrapment, or nonexpandable lung, according to the study report.

In the talc group, pleurodesis was successful at day 35 in 30 of 69 patients (43%) versus 16 of 70 patients (23%) in the placebo group (P = .008).

At day 70, the success rate was 51% for the talc group vs. 27% for the placebo group, respectively.

The rate of pleurodesis was significantly higher when talc was administered through an indwelling pleural catheter, Dr. Bhatnagar and his colleagues noted.

“Success rates at day 70 suggested that pleurodesis was maintained to a point that is clinically relevant for patients with short median survival,” they added.

No excess of side effects or catheter blockages were associated with talc vs. placebo administration through a catheter. Additionally, no differences were seen between the talc and placebo groups in the number of adverse events, number of inpatient days, mortality, or other outcomes tracked by the researchers.

Dr. Bhatnagar reported he had no disclosures related to the study. Study coauthors reported disclosures related to Becton Dickinson – CareFusion, Rosetrees Trust, GE Medical, and Rocket Medical. Becton Dickinson supported the trial with an unrestricted research grant and supplied catheters and drainage bottles for the study’s participants.

SOURCE: Bhatnagar R et al. N Engl J Med. 2018;378:1313-22.

Patients with malignant pleural effusion treated with an indwelling pleural catheter have an improved chance of a positive outcome when talc administration is part of their procedure, suggest the results of a randomized, placebo-controlled study.

Malignant pleural effusion, which is usually caused by the spread of metastatic cancer, is typically treated by inducement of pleurodesis. Talc is probably the most effective agent for achieving this result, but there are drawbacks to using talc to induce pleurodesis. Patients who receive this treatment often need to stay in the hospital for 4-7 days, according to Rahul Bhatnagar, PhD, and the coauthors of a study published in the New England Journal of Medicine). Indwelling pleural catheters provide an “ambulatory alternative” for fluid management, they noted. In a noncomparative series of 22 patients, administering talc through such a catheter produced high rates of pleurodesis, they added.

In the new study, Dr. Bhatnagar of the Academic Respiratory Unit, University of Bristol, England, and his coauthors evaluated the use of an indwelling catheter, with or without talc, in patients with malignant pleural effusion recruited at 18 centers in the United Kingdom over 4 years.

“Our primary-outcome results, which were backed up by robust sensitivity analyses, strongly suggest that the administration of talc through an indwelling pleural catheter was significantly more efficacious than the use of an indwelling pleural catheter alone among patients without substantial lung entrapment,” the authors wrote.

A total of 154 patients underwent randomization to the talc or placebo group, and 139 had sufficient data to evaluate the primary outcome of successful pleurodesis at 35 days after randomization. The researchers excluded patients with evidence of lung entrapment, or nonexpandable lung, according to the study report.

In the talc group, pleurodesis was successful at day 35 in 30 of 69 patients (43%) versus 16 of 70 patients (23%) in the placebo group (P = .008).

At day 70, the success rate was 51% for the talc group vs. 27% for the placebo group, respectively.

The rate of pleurodesis was significantly higher when talc was administered through an indwelling pleural catheter, Dr. Bhatnagar and his colleagues noted.

“Success rates at day 70 suggested that pleurodesis was maintained to a point that is clinically relevant for patients with short median survival,” they added.

No excess of side effects or catheter blockages were associated with talc vs. placebo administration through a catheter. Additionally, no differences were seen between the talc and placebo groups in the number of adverse events, number of inpatient days, mortality, or other outcomes tracked by the researchers.

Dr. Bhatnagar reported he had no disclosures related to the study. Study coauthors reported disclosures related to Becton Dickinson – CareFusion, Rosetrees Trust, GE Medical, and Rocket Medical. Becton Dickinson supported the trial with an unrestricted research grant and supplied catheters and drainage bottles for the study’s participants.

SOURCE: Bhatnagar R et al. N Engl J Med. 2018;378:1313-22.

Patients with malignant pleural effusion treated with an indwelling pleural catheter have an improved chance of a positive outcome when talc administration is part of their procedure, suggest the results of a randomized, placebo-controlled study.

Malignant pleural effusion, which is usually caused by the spread of metastatic cancer, is typically treated by inducement of pleurodesis. Talc is probably the most effective agent for achieving this result, but there are drawbacks to using talc to induce pleurodesis. Patients who receive this treatment often need to stay in the hospital for 4-7 days, according to Rahul Bhatnagar, PhD, and the coauthors of a study published in the New England Journal of Medicine). Indwelling pleural catheters provide an “ambulatory alternative” for fluid management, they noted. In a noncomparative series of 22 patients, administering talc through such a catheter produced high rates of pleurodesis, they added.

In the new study, Dr. Bhatnagar of the Academic Respiratory Unit, University of Bristol, England, and his coauthors evaluated the use of an indwelling catheter, with or without talc, in patients with malignant pleural effusion recruited at 18 centers in the United Kingdom over 4 years.

“Our primary-outcome results, which were backed up by robust sensitivity analyses, strongly suggest that the administration of talc through an indwelling pleural catheter was significantly more efficacious than the use of an indwelling pleural catheter alone among patients without substantial lung entrapment,” the authors wrote.

A total of 154 patients underwent randomization to the talc or placebo group, and 139 had sufficient data to evaluate the primary outcome of successful pleurodesis at 35 days after randomization. The researchers excluded patients with evidence of lung entrapment, or nonexpandable lung, according to the study report.

In the talc group, pleurodesis was successful at day 35 in 30 of 69 patients (43%) versus 16 of 70 patients (23%) in the placebo group (P = .008).

At day 70, the success rate was 51% for the talc group vs. 27% for the placebo group, respectively.

The rate of pleurodesis was significantly higher when talc was administered through an indwelling pleural catheter, Dr. Bhatnagar and his colleagues noted.

“Success rates at day 70 suggested that pleurodesis was maintained to a point that is clinically relevant for patients with short median survival,” they added.

No excess of side effects or catheter blockages were associated with talc vs. placebo administration through a catheter. Additionally, no differences were seen between the talc and placebo groups in the number of adverse events, number of inpatient days, mortality, or other outcomes tracked by the researchers.

Dr. Bhatnagar reported he had no disclosures related to the study. Study coauthors reported disclosures related to Becton Dickinson – CareFusion, Rosetrees Trust, GE Medical, and Rocket Medical. Becton Dickinson supported the trial with an unrestricted research grant and supplied catheters and drainage bottles for the study’s participants.

SOURCE: Bhatnagar R et al. N Engl J Med. 2018;378:1313-22.

The oral immunomodulatory drug lenalidomide is active and may provide prolonged responses in certain patients with a rare and aggressive subtype of primary cutaneous lymphoma, according to results of a phase 2 study.

In the study, which comprised 19 patients with primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), 5 patients (26.3%) had a response at 6 months, and there were still 3 patients in response at 12 months. The findings were reported in the Journal of Investigative Dermatology.

In an exploratory analysis, reducing the dose of lenalidomide was associated with prolonged response and improved survival, noted lead author Marie Beylot-Barry, MD, of the dermatology department, Hôpital Saint-André, CHU Bordeaux, France, and her colleagues.

“Lenalidomide at reduced doses may allow prolonged responses in few patients, and represents a therapeutic option in relapsing/refractory PCDLBCL, LT,” the researchers wrote.

Found mostly on the lower limbs of elderly patients, PCDLBCL, LT exhibits aggressive behavior and is associated with a high rate of skin recurrences. First-line therapy for the cutaneous lymphoma is typically rituximab and chemotherapy, regardless of clinical stage or patient age, the researchers wrote, though primary resistance or recurrence after treatment occurs in about half of patients. “In such relapsing or refractory cases, no treatment has demonstrated a sustained benefit thus far,” they noted.

Lenalidomide has already demonstrated efficacy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and it induces inhibition of cell signaling, engaging NF-kappaB signaling. PCDLBCL, LT is marked by genetic alterations leading to the NF-kappaB pathway, which represents a therapeutic target.

Dr. Beylot-Barry and her colleagues initiated a multicenter, single-arm, phase 2 trial of 19 patients refractory/relapsing PCDLBCL, LT. Median progression-free survival in the trial was 4.9 months. The 6-month overall response rate – the primary endpoint of the trial – was 26.3%, which was not significantly superior to a prespecified 20% minimal response rate, according to the researchers.

SOURCE: Beylot-Barry M et al. J Invest Dermatol. 2018 Mar 26. doi: 10.1016/j.jid.2018.03.1516.

The oral immunomodulatory drug lenalidomide is active and may provide prolonged responses in certain patients with a rare and aggressive subtype of primary cutaneous lymphoma, according to results of a phase 2 study.

In the study, which comprised 19 patients with primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), 5 patients (26.3%) had a response at 6 months, and there were still 3 patients in response at 12 months. The findings were reported in the Journal of Investigative Dermatology.

In an exploratory analysis, reducing the dose of lenalidomide was associated with prolonged response and improved survival, noted lead author Marie Beylot-Barry, MD, of the dermatology department, Hôpital Saint-André, CHU Bordeaux, France, and her colleagues.

“Lenalidomide at reduced doses may allow prolonged responses in few patients, and represents a therapeutic option in relapsing/refractory PCDLBCL, LT,” the researchers wrote.

Found mostly on the lower limbs of elderly patients, PCDLBCL, LT exhibits aggressive behavior and is associated with a high rate of skin recurrences. First-line therapy for the cutaneous lymphoma is typically rituximab and chemotherapy, regardless of clinical stage or patient age, the researchers wrote, though primary resistance or recurrence after treatment occurs in about half of patients. “In such relapsing or refractory cases, no treatment has demonstrated a sustained benefit thus far,” they noted.

Lenalidomide has already demonstrated efficacy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and it induces inhibition of cell signaling, engaging NF-kappaB signaling. PCDLBCL, LT is marked by genetic alterations leading to the NF-kappaB pathway, which represents a therapeutic target.

Dr. Beylot-Barry and her colleagues initiated a multicenter, single-arm, phase 2 trial of 19 patients refractory/relapsing PCDLBCL, LT. Median progression-free survival in the trial was 4.9 months. The 6-month overall response rate – the primary endpoint of the trial – was 26.3%, which was not significantly superior to a prespecified 20% minimal response rate, according to the researchers.

SOURCE: Beylot-Barry M et al. J Invest Dermatol. 2018 Mar 26. doi: 10.1016/j.jid.2018.03.1516.

The oral immunomodulatory drug lenalidomide is active and may provide prolonged responses in certain patients with a rare and aggressive subtype of primary cutaneous lymphoma, according to results of a phase 2 study.

In the study, which comprised 19 patients with primary cutaneous diffuse large B-cell lymphoma, leg type (PCDLBCL, LT), 5 patients (26.3%) had a response at 6 months, and there were still 3 patients in response at 12 months. The findings were reported in the Journal of Investigative Dermatology.

In an exploratory analysis, reducing the dose of lenalidomide was associated with prolonged response and improved survival, noted lead author Marie Beylot-Barry, MD, of the dermatology department, Hôpital Saint-André, CHU Bordeaux, France, and her colleagues.

“Lenalidomide at reduced doses may allow prolonged responses in few patients, and represents a therapeutic option in relapsing/refractory PCDLBCL, LT,” the researchers wrote.

Found mostly on the lower limbs of elderly patients, PCDLBCL, LT exhibits aggressive behavior and is associated with a high rate of skin recurrences. First-line therapy for the cutaneous lymphoma is typically rituximab and chemotherapy, regardless of clinical stage or patient age, the researchers wrote, though primary resistance or recurrence after treatment occurs in about half of patients. “In such relapsing or refractory cases, no treatment has demonstrated a sustained benefit thus far,” they noted.

Lenalidomide has already demonstrated efficacy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and it induces inhibition of cell signaling, engaging NF-kappaB signaling. PCDLBCL, LT is marked by genetic alterations leading to the NF-kappaB pathway, which represents a therapeutic target.

Dr. Beylot-Barry and her colleagues initiated a multicenter, single-arm, phase 2 trial of 19 patients refractory/relapsing PCDLBCL, LT. Median progression-free survival in the trial was 4.9 months. The 6-month overall response rate – the primary endpoint of the trial – was 26.3%, which was not significantly superior to a prespecified 20% minimal response rate, according to the researchers.

SOURCE: Beylot-Barry M et al. J Invest Dermatol. 2018 Mar 26. doi: 10.1016/j.jid.2018.03.1516.

In order to distinguish neurogenic from nonneurogenic causes of orthostatic hypotension, looking at the change in heart rate (cHR) in relation to the change in systolic blood pressure (cSBP) may be superior to looking at heart rate alone.

A cHR/cSBP ratio of 0.492 beats per minute (bpm)/mm Hg had the best sensitivity and specificity to distinguish neurogenic from nonneurogenic causes, according to results of a prospective study published in Annals of Neurology.

Accordingly, Dr. Norcliffe-Kaufmann and her colleagues conducted a study of consecutive adult patients referred for autonomic evaluation at sites of the U.S. Autonomic Consortium.

The analysis was based on 402 patients with orthostatic hypotension who had normal sinus rhythm at the time of evaluation. Of that group, 378 had neurogenic orthostatic hypotension and were diagnosed with Parkinson disease, dementia with Lewy bodies, pure autonomic failure, or multiple system atrophy.

Patients with neurogenic orthostatic hypotension had twice the fall in SBP versus those with nonneurogenic causes (–43 vs. –21 mm Hg; P less than .0001), yet only about a third of the HR increase (8 vs. 25 bpm; P less than .0001), researchers reported.

They found the cHR/cSBP ratio of 0.492 bpm/mm Hg had the best sensitivity (91.3%) and specificity (88.4%) to distinguish between patients with neurogenic and nonneurogenic orthostatic hypertension.

By contrast, orthostatic HR increase by itself was a poor discriminator, according to the researchers, who reported that an HR increase of less than 17 bpm had just moderate sensitivity (79%) and specificity (87%).

“Using this simple bedside test of how much the blood pressure falls and heart rate increases can help in screening these patients,” Dr. Norcliffe-Kaufmann said of the results. “Then they can be sent to an autonomic clinic to really confirm the diagnosis with a sophisticated autonomic function test.”

The researchers also sought to determine whether the differences in heart rate could distinguish between central and peripheral causes of neurogenic orthostatic hypotension. They found that heart rate increased more in patients with multiple system atrophy, but noted “considerable overlap” with patients with Lewy body disorders, according to the findings.

“It didn’t really pan out as a way to distinguish the two forms from one another with enough sensitivity or specificity,” Dr. Norcliffe-Kaufmann said.

The findings do suggest, however, that looking at the cHR/cSBP ratio could help identify neurogenic orthostatic hypotension earlier, reducing delays in treatment and decreasing the need for expensive testing, the researchers said.

“I think there will be a place for genuine, solid autonomic function tests, but many patients cannot get referred to these services, or they don’t have these specialist medical centers on their doorstep, particularly in rural communities,” Dr. Norcliffe-Kaufmann said in the interview.

The study was supported by the National institutes of Health Rare Disease Clinical Research Network. Dr. Norcliffe-Kaufmann and her coauthors reported no potential conflicts of interest.

SOURCE: Norcliffe-Kaufmann L et al. Ann Neurol. 2018 Mar;83(3):522-31.

In order to distinguish neurogenic from nonneurogenic causes of orthostatic hypotension, looking at the change in heart rate (cHR) in relation to the change in systolic blood pressure (cSBP) may be superior to looking at heart rate alone.

A cHR/cSBP ratio of 0.492 beats per minute (bpm)/mm Hg had the best sensitivity and specificity to distinguish neurogenic from nonneurogenic causes, according to results of a prospective study published in Annals of Neurology.

Accordingly, Dr. Norcliffe-Kaufmann and her colleagues conducted a study of consecutive adult patients referred for autonomic evaluation at sites of the U.S. Autonomic Consortium.

The analysis was based on 402 patients with orthostatic hypotension who had normal sinus rhythm at the time of evaluation. Of that group, 378 had neurogenic orthostatic hypotension and were diagnosed with Parkinson disease, dementia with Lewy bodies, pure autonomic failure, or multiple system atrophy.

Patients with neurogenic orthostatic hypotension had twice the fall in SBP versus those with nonneurogenic causes (–43 vs. –21 mm Hg; P less than .0001), yet only about a third of the HR increase (8 vs. 25 bpm; P less than .0001), researchers reported.

They found the cHR/cSBP ratio of 0.492 bpm/mm Hg had the best sensitivity (91.3%) and specificity (88.4%) to distinguish between patients with neurogenic and nonneurogenic orthostatic hypertension.

By contrast, orthostatic HR increase by itself was a poor discriminator, according to the researchers, who reported that an HR increase of less than 17 bpm had just moderate sensitivity (79%) and specificity (87%).

“Using this simple bedside test of how much the blood pressure falls and heart rate increases can help in screening these patients,” Dr. Norcliffe-Kaufmann said of the results. “Then they can be sent to an autonomic clinic to really confirm the diagnosis with a sophisticated autonomic function test.”

The researchers also sought to determine whether the differences in heart rate could distinguish between central and peripheral causes of neurogenic orthostatic hypotension. They found that heart rate increased more in patients with multiple system atrophy, but noted “considerable overlap” with patients with Lewy body disorders, according to the findings.

“It didn’t really pan out as a way to distinguish the two forms from one another with enough sensitivity or specificity,” Dr. Norcliffe-Kaufmann said.

The findings do suggest, however, that looking at the cHR/cSBP ratio could help identify neurogenic orthostatic hypotension earlier, reducing delays in treatment and decreasing the need for expensive testing, the researchers said.

“I think there will be a place for genuine, solid autonomic function tests, but many patients cannot get referred to these services, or they don’t have these specialist medical centers on their doorstep, particularly in rural communities,” Dr. Norcliffe-Kaufmann said in the interview.

The study was supported by the National institutes of Health Rare Disease Clinical Research Network. Dr. Norcliffe-Kaufmann and her coauthors reported no potential conflicts of interest.

SOURCE: Norcliffe-Kaufmann L et al. Ann Neurol. 2018 Mar;83(3):522-31.

In order to distinguish neurogenic from nonneurogenic causes of orthostatic hypotension, looking at the change in heart rate (cHR) in relation to the change in systolic blood pressure (cSBP) may be superior to looking at heart rate alone.

A cHR/cSBP ratio of 0.492 beats per minute (bpm)/mm Hg had the best sensitivity and specificity to distinguish neurogenic from nonneurogenic causes, according to results of a prospective study published in Annals of Neurology.

Accordingly, Dr. Norcliffe-Kaufmann and her colleagues conducted a study of consecutive adult patients referred for autonomic evaluation at sites of the U.S. Autonomic Consortium.

The analysis was based on 402 patients with orthostatic hypotension who had normal sinus rhythm at the time of evaluation. Of that group, 378 had neurogenic orthostatic hypotension and were diagnosed with Parkinson disease, dementia with Lewy bodies, pure autonomic failure, or multiple system atrophy.

Patients with neurogenic orthostatic hypotension had twice the fall in SBP versus those with nonneurogenic causes (–43 vs. –21 mm Hg; P less than .0001), yet only about a third of the HR increase (8 vs. 25 bpm; P less than .0001), researchers reported.

They found the cHR/cSBP ratio of 0.492 bpm/mm Hg had the best sensitivity (91.3%) and specificity (88.4%) to distinguish between patients with neurogenic and nonneurogenic orthostatic hypertension.

By contrast, orthostatic HR increase by itself was a poor discriminator, according to the researchers, who reported that an HR increase of less than 17 bpm had just moderate sensitivity (79%) and specificity (87%).

“Using this simple bedside test of how much the blood pressure falls and heart rate increases can help in screening these patients,” Dr. Norcliffe-Kaufmann said of the results. “Then they can be sent to an autonomic clinic to really confirm the diagnosis with a sophisticated autonomic function test.”

The researchers also sought to determine whether the differences in heart rate could distinguish between central and peripheral causes of neurogenic orthostatic hypotension. They found that heart rate increased more in patients with multiple system atrophy, but noted “considerable overlap” with patients with Lewy body disorders, according to the findings.

“It didn’t really pan out as a way to distinguish the two forms from one another with enough sensitivity or specificity,” Dr. Norcliffe-Kaufmann said.

The findings do suggest, however, that looking at the cHR/cSBP ratio could help identify neurogenic orthostatic hypotension earlier, reducing delays in treatment and decreasing the need for expensive testing, the researchers said.

“I think there will be a place for genuine, solid autonomic function tests, but many patients cannot get referred to these services, or they don’t have these specialist medical centers on their doorstep, particularly in rural communities,” Dr. Norcliffe-Kaufmann said in the interview.

The study was supported by the National institutes of Health Rare Disease Clinical Research Network. Dr. Norcliffe-Kaufmann and her coauthors reported no potential conflicts of interest.

SOURCE: Norcliffe-Kaufmann L et al. Ann Neurol. 2018 Mar;83(3):522-31.

Most adult patients with psoriatic arthritis who newly initiate biologic therapy with a tumor necrosis factor (TNF) inhibitor or anti–interleukin-12/23 inhibitor discontinued the treatment before a year is up, according to a recent analysis of a U.S. claims database.

Over a 12-month follow-up period, 27% of psoriatic arthritis (PsA) patients discontinued the index biologic, 23% switched to a different biologic, and 6% discontinued the index biologic but later restarted it, according to the results, which were published in the Journal of Managed Care & Specialty Pharmacy.

Mitchel L. Zoler/Frontine Medical News

SOURCE: Walsh JA et al. J Manag Care Spec Pharm. 2018 Mar 20. doi: 10.18553/jmcp.2018.17388.

Most adult patients with psoriatic arthritis who newly initiate biologic therapy with a tumor necrosis factor (TNF) inhibitor or anti–interleukin-12/23 inhibitor discontinued the treatment before a year is up, according to a recent analysis of a U.S. claims database.

Over a 12-month follow-up period, 27% of psoriatic arthritis (PsA) patients discontinued the index biologic, 23% switched to a different biologic, and 6% discontinued the index biologic but later restarted it, according to the results, which were published in the Journal of Managed Care & Specialty Pharmacy.

Mitchel L. Zoler/Frontine Medical News

SOURCE: Walsh JA et al. J Manag Care Spec Pharm. 2018 Mar 20. doi: 10.18553/jmcp.2018.17388.

Most adult patients with psoriatic arthritis who newly initiate biologic therapy with a tumor necrosis factor (TNF) inhibitor or anti–interleukin-12/23 inhibitor discontinued the treatment before a year is up, according to a recent analysis of a U.S. claims database.

Over a 12-month follow-up period, 27% of psoriatic arthritis (PsA) patients discontinued the index biologic, 23% switched to a different biologic, and 6% discontinued the index biologic but later restarted it, according to the results, which were published in the Journal of Managed Care & Specialty Pharmacy.

Mitchel L. Zoler/Frontine Medical News

SOURCE: Walsh JA et al. J Manag Care Spec Pharm. 2018 Mar 20. doi: 10.18553/jmcp.2018.17388.

Contrary to prior reports, certolizumab pegol may not be associated with an increased risk of serious infections versus other biologics used in the treatment of rheumatoid arthritis, according to results of a recent U.K. registry study.

Certolizumab pegol (Cimzia) actually had a lower risk of serious infections, compared with etanercept in the primary analysis, according to a report on the study recently published in Annals of the Rheumatic Diseases.

In sensitivity analyses, though, the result in favor of certolizumab pegol was no longer significant, according to lead author Andrew I. Rutherford, MBBS, of King’s College London, and his coauthors.

“From these results, it would be wrong to conclude that certolizumab pegol has a lower rate of [serious infection] than other biologics,” Dr. Rutherford and his colleagues said in their report. “However, the risk does not appear to be significantly higher as has previously been suggested.”

The prospective, observational cohort study, based on data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA), represented 19,282 patients with 46,771 years of follow-up, according to the authors.

For the entire cohort, the incidence of serious infections was 5.51 cases per 100 patient-years (95% confidence interval, 5.29-5.71), and the 30-day mortality after serious infection was 10.4% (95% CI, 9.2%-11.6%), the report said. Compared with etanercept, the risk of serious infections was lower for certolizumab pegol (adjusted hazard ratio, 0.75; 95% CI, 0.58-0.97). Etanercept was used as the reference arm for comparison since it was the most widely prescribed drug in the registry.

That finding is in “direct contradiction” to a 2011 Cochrane review finding that certolizumab pegol was associated with an infection rate three to four times higher than other anti–tumor necrosis factor (anti-TNF) drugs (Cochrane Database Syst Rev. 2011;2:Cd008794), the authors noted.

SOURCE: Rutherford AI et al. Ann Rheum Dis. 2018 Mar 28. doi: 10.1136/annrheumdis-2017-212825.

Contrary to prior reports, certolizumab pegol may not be associated with an increased risk of serious infections versus other biologics used in the treatment of rheumatoid arthritis, according to results of a recent U.K. registry study.

Certolizumab pegol (Cimzia) actually had a lower risk of serious infections, compared with etanercept in the primary analysis, according to a report on the study recently published in Annals of the Rheumatic Diseases.

In sensitivity analyses, though, the result in favor of certolizumab pegol was no longer significant, according to lead author Andrew I. Rutherford, MBBS, of King’s College London, and his coauthors.

“From these results, it would be wrong to conclude that certolizumab pegol has a lower rate of [serious infection] than other biologics,” Dr. Rutherford and his colleagues said in their report. “However, the risk does not appear to be significantly higher as has previously been suggested.”

The prospective, observational cohort study, based on data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA), represented 19,282 patients with 46,771 years of follow-up, according to the authors.

For the entire cohort, the incidence of serious infections was 5.51 cases per 100 patient-years (95% confidence interval, 5.29-5.71), and the 30-day mortality after serious infection was 10.4% (95% CI, 9.2%-11.6%), the report said. Compared with etanercept, the risk of serious infections was lower for certolizumab pegol (adjusted hazard ratio, 0.75; 95% CI, 0.58-0.97). Etanercept was used as the reference arm for comparison since it was the most widely prescribed drug in the registry.

That finding is in “direct contradiction” to a 2011 Cochrane review finding that certolizumab pegol was associated with an infection rate three to four times higher than other anti–tumor necrosis factor (anti-TNF) drugs (Cochrane Database Syst Rev. 2011;2:Cd008794), the authors noted.

SOURCE: Rutherford AI et al. Ann Rheum Dis. 2018 Mar 28. doi: 10.1136/annrheumdis-2017-212825.

Contrary to prior reports, certolizumab pegol may not be associated with an increased risk of serious infections versus other biologics used in the treatment of rheumatoid arthritis, according to results of a recent U.K. registry study.

Certolizumab pegol (Cimzia) actually had a lower risk of serious infections, compared with etanercept in the primary analysis, according to a report on the study recently published in Annals of the Rheumatic Diseases.

In sensitivity analyses, though, the result in favor of certolizumab pegol was no longer significant, according to lead author Andrew I. Rutherford, MBBS, of King’s College London, and his coauthors.

“From these results, it would be wrong to conclude that certolizumab pegol has a lower rate of [serious infection] than other biologics,” Dr. Rutherford and his colleagues said in their report. “However, the risk does not appear to be significantly higher as has previously been suggested.”

The prospective, observational cohort study, based on data from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA), represented 19,282 patients with 46,771 years of follow-up, according to the authors.

For the entire cohort, the incidence of serious infections was 5.51 cases per 100 patient-years (95% confidence interval, 5.29-5.71), and the 30-day mortality after serious infection was 10.4% (95% CI, 9.2%-11.6%), the report said. Compared with etanercept, the risk of serious infections was lower for certolizumab pegol (adjusted hazard ratio, 0.75; 95% CI, 0.58-0.97). Etanercept was used as the reference arm for comparison since it was the most widely prescribed drug in the registry.

That finding is in “direct contradiction” to a 2011 Cochrane review finding that certolizumab pegol was associated with an infection rate three to four times higher than other anti–tumor necrosis factor (anti-TNF) drugs (Cochrane Database Syst Rev. 2011;2:Cd008794), the authors noted.

SOURCE: Rutherford AI et al. Ann Rheum Dis. 2018 Mar 28. doi: 10.1136/annrheumdis-2017-212825.

Laws covering medical or recreational use of marijuana are associated with reduced rates of opioid prescribing among federal health care program enrollees, results of two recently published investigations show.

In one study, researchers investigated whether medical cannabis access affected opioid prescribing in Medicare Part D, the federal program that subsidizes cost of prescription drugs and drug insurance premiums.

©rozmarina/Thinkstock

However, adult-use marijuana laws were associated with “even-lower” opioid prescribing rates, something that had not been investigated previously, according to Dr. Wen, who is with the University of Kentucky, Lexington, and Dr. Hockenberry of Emory University, Atlanta.

“Medical and adult-use marijuana laws have the potential to lower opioid prescribing for Medicaid enrollees, a high-risk population for chronic pain, opioid use disorder, and opioid overdose,” Dr. Wen and Dr. Hockenberry wrote in their report on the study, a cross-sectional analysis including all Medicaid fee-for-service and managed care enrollees during 2011-2016.

The rate of opioid prescribing in the study was –5.88% lower (95% confidence interval, –11.55% to approximately –0.21%) in association with medical marijuana laws, and –6.38% lower (95% CI, –12.20% to approximately –0.56%) for adult-use laws, they reported.

Based on those findings, policy discussions about the opioid epidemic should include the potential for liberalization of marijuana policies to reduce prescription opioid use and consequences in Medicaid enrollees, Dr. Wen and Dr. Hockenberry concluded.

However, legal marijuana alone won’t solve the opioid epidemic, they cautioned.

“As with other policies evaluated in the previous literature, marijuana liberalization is but one potential aspect of a comprehensive package to tackle the epidemic,” they said in the article.

None of the study authors reported conflicts of interest.

SOURCES: Bradford AC et al. JAMA Intern Med. 2018 Apr 2. doi: 10.1001/jamainternmed.2018.0266; Wen H, Hockenberry JM. JAMA Intern Med. 2018 Apr 2. doi: 10.1001/jamainternmed.2018.1007.

Laws covering medical or recreational use of marijuana are associated with reduced rates of opioid prescribing among federal health care program enrollees, results of two recently published investigations show.

In one study, researchers investigated whether medical cannabis access affected opioid prescribing in Medicare Part D, the federal program that subsidizes cost of prescription drugs and drug insurance premiums.

©rozmarina/Thinkstock

However, adult-use marijuana laws were associated with “even-lower” opioid prescribing rates, something that had not been investigated previously, according to Dr. Wen, who is with the University of Kentucky, Lexington, and Dr. Hockenberry of Emory University, Atlanta.

“Medical and adult-use marijuana laws have the potential to lower opioid prescribing for Medicaid enrollees, a high-risk population for chronic pain, opioid use disorder, and opioid overdose,” Dr. Wen and Dr. Hockenberry wrote in their report on the study, a cross-sectional analysis including all Medicaid fee-for-service and managed care enrollees during 2011-2016.

The rate of opioid prescribing in the study was –5.88% lower (95% confidence interval, –11.55% to approximately –0.21%) in association with medical marijuana laws, and –6.38% lower (95% CI, –12.20% to approximately –0.56%) for adult-use laws, they reported.

Based on those findings, policy discussions about the opioid epidemic should include the potential for liberalization of marijuana policies to reduce prescription opioid use and consequences in Medicaid enrollees, Dr. Wen and Dr. Hockenberry concluded.

However, legal marijuana alone won’t solve the opioid epidemic, they cautioned.

“As with other policies evaluated in the previous literature, marijuana liberalization is but one potential aspect of a comprehensive package to tackle the epidemic,” they said in the article.

None of the study authors reported conflicts of interest.

SOURCES: Bradford AC et al. JAMA Intern Med. 2018 Apr 2. doi: 10.1001/jamainternmed.2018.0266; Wen H, Hockenberry JM. JAMA Intern Med. 2018 Apr 2. doi: 10.1001/jamainternmed.2018.1007.

Laws covering medical or recreational use of marijuana are associated with reduced rates of opioid prescribing among federal health care program enrollees, results of two recently published investigations show.

In one study, researchers investigated whether medical cannabis access affected opioid prescribing in Medicare Part D, the federal program that subsidizes cost of prescription drugs and drug insurance premiums.

©rozmarina/Thinkstock

However, adult-use marijuana laws were associated with “even-lower” opioid prescribing rates, something that had not been investigated previously, according to Dr. Wen, who is with the University of Kentucky, Lexington, and Dr. Hockenberry of Emory University, Atlanta.

“Medical and adult-use marijuana laws have the potential to lower opioid prescribing for Medicaid enrollees, a high-risk population for chronic pain, opioid use disorder, and opioid overdose,” Dr. Wen and Dr. Hockenberry wrote in their report on the study, a cross-sectional analysis including all Medicaid fee-for-service and managed care enrollees during 2011-2016.

The rate of opioid prescribing in the study was –5.88% lower (95% confidence interval, –11.55% to approximately –0.21%) in association with medical marijuana laws, and –6.38% lower (95% CI, –12.20% to approximately –0.56%) for adult-use laws, they reported.

Based on those findings, policy discussions about the opioid epidemic should include the potential for liberalization of marijuana policies to reduce prescription opioid use and consequences in Medicaid enrollees, Dr. Wen and Dr. Hockenberry concluded.

However, legal marijuana alone won’t solve the opioid epidemic, they cautioned.

“As with other policies evaluated in the previous literature, marijuana liberalization is but one potential aspect of a comprehensive package to tackle the epidemic,” they said in the article.

None of the study authors reported conflicts of interest.

SOURCES: Bradford AC et al. JAMA Intern Med. 2018 Apr 2. doi: 10.1001/jamainternmed.2018.0266; Wen H, Hockenberry JM. JAMA Intern Med. 2018 Apr 2. doi: 10.1001/jamainternmed.2018.1007.

For women with ovarian cancer, an oncologist-led BRCA1/2 (BRCAm) counseling process is associated with favorable waiting times for test results and high levels of satisfaction, according to results of a prospective observational study.

The median turnaround time from initial counseling to receiving a test result was 9.1 weeks, investigators reported in the Journal of Clinical Oncology.

“Following a pathway similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer,” said lead author Nicoletta Colombo, MD, of European Institute of Oncology, University of Milan-Bicocca, Italy, and her associates.

Establishing an ovarian cancer patient’s BRCAm status provides useful prognostic information and helps identify patients most likely to benefit from therapy with poly(ADP-ribose) polymerase (PARP) inhibitors, Dr. Colombo and her colleagues wrote.

However, despite guideline recommendations, many patients with an ovarian cancer diagnosis are currently not receiving BRCAm testing, they added.

“Given the high volume of BRCAm tests now being ordered, a new, more streamlined testing approach is needed to shorten testing turnaround times and to ease the pressure on genetic counselors,” the authors said.

In a pilot study from the United Kingdom, a streamlined, oncologist-led BRCAm testing model reduced a 20-week average turnaround time by fourfold, Dr. Colombo and her colleagues said.

op@mdedge.com

SOURCE: Colombo N et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.76.278.

For women with ovarian cancer, an oncologist-led BRCA1/2 (BRCAm) counseling process is associated with favorable waiting times for test results and high levels of satisfaction, according to results of a prospective observational study.

The median turnaround time from initial counseling to receiving a test result was 9.1 weeks, investigators reported in the Journal of Clinical Oncology.

“Following a pathway similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer,” said lead author Nicoletta Colombo, MD, of European Institute of Oncology, University of Milan-Bicocca, Italy, and her associates.

Establishing an ovarian cancer patient’s BRCAm status provides useful prognostic information and helps identify patients most likely to benefit from therapy with poly(ADP-ribose) polymerase (PARP) inhibitors, Dr. Colombo and her colleagues wrote.

However, despite guideline recommendations, many patients with an ovarian cancer diagnosis are currently not receiving BRCAm testing, they added.

“Given the high volume of BRCAm tests now being ordered, a new, more streamlined testing approach is needed to shorten testing turnaround times and to ease the pressure on genetic counselors,” the authors said.

In a pilot study from the United Kingdom, a streamlined, oncologist-led BRCAm testing model reduced a 20-week average turnaround time by fourfold, Dr. Colombo and her colleagues said.

op@mdedge.com

SOURCE: Colombo N et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.76.278.

For women with ovarian cancer, an oncologist-led BRCA1/2 (BRCAm) counseling process is associated with favorable waiting times for test results and high levels of satisfaction, according to results of a prospective observational study.

The median turnaround time from initial counseling to receiving a test result was 9.1 weeks, investigators reported in the Journal of Clinical Oncology.

“Following a pathway similar to the one used in this study could allow faster treatment decisions and better use of resources in the management of patients with ovarian cancer,” said lead author Nicoletta Colombo, MD, of European Institute of Oncology, University of Milan-Bicocca, Italy, and her associates.

Establishing an ovarian cancer patient’s BRCAm status provides useful prognostic information and helps identify patients most likely to benefit from therapy with poly(ADP-ribose) polymerase (PARP) inhibitors, Dr. Colombo and her colleagues wrote.

However, despite guideline recommendations, many patients with an ovarian cancer diagnosis are currently not receiving BRCAm testing, they added.

“Given the high volume of BRCAm tests now being ordered, a new, more streamlined testing approach is needed to shorten testing turnaround times and to ease the pressure on genetic counselors,” the authors said.

In a pilot study from the United Kingdom, a streamlined, oncologist-led BRCAm testing model reduced a 20-week average turnaround time by fourfold, Dr. Colombo and her colleagues said.

op@mdedge.com

SOURCE: Colombo N et al. J Clin Oncol. 2018 Mar 20. doi: 10.1200/JCO.2017.76.278.

In mantle cell lymphoma (MCL), ibrutinib plus venetoclax significantly improved the complete response rate, compared with what has been previously reported for ibrutinib alone, according to results of a phase 2 study.

Clinical outcomes with the combination seem superior to previously reported results for either treatment alone, said lead investigator Constantine S. Tam, MBBS, MD, of the Peter MacCallum Cancer Centre, Melbourne, and his coinvestigators.

“The results of our study, which used a historical cohort as a control, are consistent with the notion that the combination of ibrutinib and venetoclax is highly effective in mantle-cell lymphoma,” the investigators wrote in the New England Journal of Medicine.

The BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are two of the most active agents for this B-cell cancer, investigators reported. The rationale for combining the agents is “compelling” because they affect different critical pathways in the malignant B cell.

Both agents have demonstrated complete response rates of 21% in previous studies of relapsed or refractory MCL, and preclinical studies suggest the combination of ibrutinib and venetoclax would be synergistic.

In the present single-group, phase 2 study, 24 patients with MCL (23 relapsed or refractory, 1 previously untreated) started ibrutinib 560 mg daily; at 4 weeks, venetoclax was started at a low dose and increased to 400 mg daily.

The study primary end point – complete response rate at week 16 assessed by CT – was 42%, compared with 9% for ibrutinib monotherapy in the phase 2 PCYC-1104-CA study (P less than .001).

Computed tomography assessment was used for the primary end point to allow comparison to the ibrutinib monotherapy study, which did not use positron emission tomography for restaging. “Our study was designed to have 80% power to reject a complete response rate of 9% (at a one-sided alpha level of 0.05) if the rate of complete response was at least 30%,” the investigators noted.

Complete response rate assessed by positron emission tomography at week 16 was 62%, and was 71% overall.

In all, 67% of patients had absence of minimal residual disease by flow cytometry. At 15 months, 78% of the responses were ongoing, and at 18 months, 57% of patients were alive and progression free.

“Such outcomes appear to be substantially better than those that have been reported for ibrutinib or venetoclax monotherapy,” the investigators wrote.

The combination had side effects that are “acceptable to both patients and physicians,” investigators wrote. Side effects, usually low grade, included diarrhea in 83% of patients, fatigue in 75%, and nausea or vomiting in 71%. Tumor lysis syndrome was seen in two patients.

Whether ibrutinib plus venetoclax is superior to ibrutinib alone is being formally evaluated in an ongoing phase 3 study.

Janssen and AbbVie partially funded the current phase 2 study. Dr. Tam reported financial ties to Janssen, AbbVie, and Pharmacyclics. Other study authors reported financial ties to various pharmaceutical companies.

SOURCE: Tam C et al. N Engl J Med. 2018;378:1211-23.

In mantle cell lymphoma (MCL), ibrutinib plus venetoclax significantly improved the complete response rate, compared with what has been previously reported for ibrutinib alone, according to results of a phase 2 study.

Clinical outcomes with the combination seem superior to previously reported results for either treatment alone, said lead investigator Constantine S. Tam, MBBS, MD, of the Peter MacCallum Cancer Centre, Melbourne, and his coinvestigators.

“The results of our study, which used a historical cohort as a control, are consistent with the notion that the combination of ibrutinib and venetoclax is highly effective in mantle-cell lymphoma,” the investigators wrote in the New England Journal of Medicine.

The BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are two of the most active agents for this B-cell cancer, investigators reported. The rationale for combining the agents is “compelling” because they affect different critical pathways in the malignant B cell.

Both agents have demonstrated complete response rates of 21% in previous studies of relapsed or refractory MCL, and preclinical studies suggest the combination of ibrutinib and venetoclax would be synergistic.

In the present single-group, phase 2 study, 24 patients with MCL (23 relapsed or refractory, 1 previously untreated) started ibrutinib 560 mg daily; at 4 weeks, venetoclax was started at a low dose and increased to 400 mg daily.

The study primary end point – complete response rate at week 16 assessed by CT – was 42%, compared with 9% for ibrutinib monotherapy in the phase 2 PCYC-1104-CA study (P less than .001).

Computed tomography assessment was used for the primary end point to allow comparison to the ibrutinib monotherapy study, which did not use positron emission tomography for restaging. “Our study was designed to have 80% power to reject a complete response rate of 9% (at a one-sided alpha level of 0.05) if the rate of complete response was at least 30%,” the investigators noted.

Complete response rate assessed by positron emission tomography at week 16 was 62%, and was 71% overall.

In all, 67% of patients had absence of minimal residual disease by flow cytometry. At 15 months, 78% of the responses were ongoing, and at 18 months, 57% of patients were alive and progression free.

“Such outcomes appear to be substantially better than those that have been reported for ibrutinib or venetoclax monotherapy,” the investigators wrote.

The combination had side effects that are “acceptable to both patients and physicians,” investigators wrote. Side effects, usually low grade, included diarrhea in 83% of patients, fatigue in 75%, and nausea or vomiting in 71%. Tumor lysis syndrome was seen in two patients.

Whether ibrutinib plus venetoclax is superior to ibrutinib alone is being formally evaluated in an ongoing phase 3 study.

Janssen and AbbVie partially funded the current phase 2 study. Dr. Tam reported financial ties to Janssen, AbbVie, and Pharmacyclics. Other study authors reported financial ties to various pharmaceutical companies.

SOURCE: Tam C et al. N Engl J Med. 2018;378:1211-23.

In mantle cell lymphoma (MCL), ibrutinib plus venetoclax significantly improved the complete response rate, compared with what has been previously reported for ibrutinib alone, according to results of a phase 2 study.

Clinical outcomes with the combination seem superior to previously reported results for either treatment alone, said lead investigator Constantine S. Tam, MBBS, MD, of the Peter MacCallum Cancer Centre, Melbourne, and his coinvestigators.

“The results of our study, which used a historical cohort as a control, are consistent with the notion that the combination of ibrutinib and venetoclax is highly effective in mantle-cell lymphoma,” the investigators wrote in the New England Journal of Medicine.

The BTK inhibitor ibrutinib and the BCL2 inhibitor venetoclax are two of the most active agents for this B-cell cancer, investigators reported. The rationale for combining the agents is “compelling” because they affect different critical pathways in the malignant B cell.

Both agents have demonstrated complete response rates of 21% in previous studies of relapsed or refractory MCL, and preclinical studies suggest the combination of ibrutinib and venetoclax would be synergistic.

In the present single-group, phase 2 study, 24 patients with MCL (23 relapsed or refractory, 1 previously untreated) started ibrutinib 560 mg daily; at 4 weeks, venetoclax was started at a low dose and increased to 400 mg daily.

The study primary end point – complete response rate at week 16 assessed by CT – was 42%, compared with 9% for ibrutinib monotherapy in the phase 2 PCYC-1104-CA study (P less than .001).

Computed tomography assessment was used for the primary end point to allow comparison to the ibrutinib monotherapy study, which did not use positron emission tomography for restaging. “Our study was designed to have 80% power to reject a complete response rate of 9% (at a one-sided alpha level of 0.05) if the rate of complete response was at least 30%,” the investigators noted.

Complete response rate assessed by positron emission tomography at week 16 was 62%, and was 71% overall.

In all, 67% of patients had absence of minimal residual disease by flow cytometry. At 15 months, 78% of the responses were ongoing, and at 18 months, 57% of patients were alive and progression free.

“Such outcomes appear to be substantially better than those that have been reported for ibrutinib or venetoclax monotherapy,” the investigators wrote.

The combination had side effects that are “acceptable to both patients and physicians,” investigators wrote. Side effects, usually low grade, included diarrhea in 83% of patients, fatigue in 75%, and nausea or vomiting in 71%. Tumor lysis syndrome was seen in two patients.

Whether ibrutinib plus venetoclax is superior to ibrutinib alone is being formally evaluated in an ongoing phase 3 study.

Janssen and AbbVie partially funded the current phase 2 study. Dr. Tam reported financial ties to Janssen, AbbVie, and Pharmacyclics. Other study authors reported financial ties to various pharmaceutical companies.

SOURCE: Tam C et al. N Engl J Med. 2018;378:1211-23.

A standardized frankincense extract was safe, well tolerated, and potentially efficacious as an oral treatment in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a small, nonrandomized study.

Patients receiving the herbal treatment had significantly fewer contrast-enhancing lesions on MRI versus baseline in the study, which was published in the Journal of Neurology, Neurosurgery & Psychiatry.

designer491/Thinkstock

Patients underwent observation for 4 months, then were treated with the extract for up to 8 months plus an optional extension phase of up to 36 months. A total of 28 patients completed the initial treatment period, and 18 participated in the extension period, according to the study results.

The median number of monthly contrast-enhancing lesions was significantly reduced from 1.00 at baseline to 0.50 during the initial treatment period (P less than .0001). In addition, significantly less brain atrophy was noted after the treatment phase as compared with the baseline observation phase (P = .0081).

Adverse events, mainly infections or gastrointestinal symptoms, were mild (57.7%) or moderate (38.6%), investigators added.

Treatment significantly increased regulatory CD4-positive T cell markers and decreased interleukin-17A–producing CD8-positive T cells, according to results of mechanistic studies that were also reported.

Other anti-inflammatory drugs that have been licensed act broadly on the immune system, according to investigators, and so those agents require careful monitoring for side effects.

“The right balance between efficacy and safety profile becomes increasingly more important for a young patient population, who require long-term treatment,” Dr. Stürner and her coauthors wrote. “The results of the SABA trial are promising from this perspective.”

The study was funded in part by Alpinia Laudanum Institute, which supplied the standardized frankincense extract at no charge. Individual authors reported competing interests with Alpinia Laudanum, Biogen, Sanofi Genzyme, Novartis, Merck Serono, and others.

SOURCE: Stürner KH et al. J Neurol Neurosurg Psychiatry. 2018 Apr;89(4):330-8.

A standardized frankincense extract was safe, well tolerated, and potentially efficacious as an oral treatment in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a small, nonrandomized study.

Patients receiving the herbal treatment had significantly fewer contrast-enhancing lesions on MRI versus baseline in the study, which was published in the Journal of Neurology, Neurosurgery & Psychiatry.

designer491/Thinkstock

Patients underwent observation for 4 months, then were treated with the extract for up to 8 months plus an optional extension phase of up to 36 months. A total of 28 patients completed the initial treatment period, and 18 participated in the extension period, according to the study results.

The median number of monthly contrast-enhancing lesions was significantly reduced from 1.00 at baseline to 0.50 during the initial treatment period (P less than .0001). In addition, significantly less brain atrophy was noted after the treatment phase as compared with the baseline observation phase (P = .0081).

Adverse events, mainly infections or gastrointestinal symptoms, were mild (57.7%) or moderate (38.6%), investigators added.

Treatment significantly increased regulatory CD4-positive T cell markers and decreased interleukin-17A–producing CD8-positive T cells, according to results of mechanistic studies that were also reported.

Other anti-inflammatory drugs that have been licensed act broadly on the immune system, according to investigators, and so those agents require careful monitoring for side effects.

“The right balance between efficacy and safety profile becomes increasingly more important for a young patient population, who require long-term treatment,” Dr. Stürner and her coauthors wrote. “The results of the SABA trial are promising from this perspective.”

The study was funded in part by Alpinia Laudanum Institute, which supplied the standardized frankincense extract at no charge. Individual authors reported competing interests with Alpinia Laudanum, Biogen, Sanofi Genzyme, Novartis, Merck Serono, and others.

SOURCE: Stürner KH et al. J Neurol Neurosurg Psychiatry. 2018 Apr;89(4):330-8.

A standardized frankincense extract was safe, well tolerated, and potentially efficacious as an oral treatment in patients with relapsing-remitting multiple sclerosis (RRMS), according to results of a small, nonrandomized study.

Patients receiving the herbal treatment had significantly fewer contrast-enhancing lesions on MRI versus baseline in the study, which was published in the Journal of Neurology, Neurosurgery & Psychiatry.

designer491/Thinkstock

Patients underwent observation for 4 months, then were treated with the extract for up to 8 months plus an optional extension phase of up to 36 months. A total of 28 patients completed the initial treatment period, and 18 participated in the extension period, according to the study results.

The median number of monthly contrast-enhancing lesions was significantly reduced from 1.00 at baseline to 0.50 during the initial treatment period (P less than .0001). In addition, significantly less brain atrophy was noted after the treatment phase as compared with the baseline observation phase (P = .0081).

Adverse events, mainly infections or gastrointestinal symptoms, were mild (57.7%) or moderate (38.6%), investigators added.

Treatment significantly increased regulatory CD4-positive T cell markers and decreased interleukin-17A–producing CD8-positive T cells, according to results of mechanistic studies that were also reported.

Other anti-inflammatory drugs that have been licensed act broadly on the immune system, according to investigators, and so those agents require careful monitoring for side effects.

“The right balance between efficacy and safety profile becomes increasingly more important for a young patient population, who require long-term treatment,” Dr. Stürner and her coauthors wrote. “The results of the SABA trial are promising from this perspective.”

The study was funded in part by Alpinia Laudanum Institute, which supplied the standardized frankincense extract at no charge. Individual authors reported competing interests with Alpinia Laudanum, Biogen, Sanofi Genzyme, Novartis, Merck Serono, and others.

SOURCE: Stürner KH et al. J Neurol Neurosurg Psychiatry. 2018 Apr;89(4):330-8.

High-dose oral ibuprofen may be most likely to result in closure of hemodynamically significant patent ductus arteriosus (PDA) in preterm infants, compared with other pharmacological treatments, according to results of a recent systematic review and meta-analysis.

However, using placebo or no treatment at all did not increase the odds of mortality, necrotizing enterocolitis, or intraventricular hemorrhage in the study, published in JAMA.

herjua/Thinkstock

They found that closure of hemodynamically significant PDA was significantly more likely with high-dose oral ibuprofen, compared with the two of the most widely used treatments, namely standard-dose intravenous ibuprofen (odds ratio, 3.59) and standard-dose intravenous indomethacin (odds ratio, 2.35).

Despite that finding, there was no significant difference in the odds of mortality, necrotizing enterocolitis, or intraventricular hemorrhage for use of placebo or no treatment, compared with any of the treatment modalities, the investigators added.

“With increasing emphasis on conservative management of PDA, these results may encourage researchers to revisit placebo-controlled trials against newer pharmacotherapeutic options,” they said.

Study authors reported no relevant potential conflicts of interest.

SOURCE: Mitra S et al. JAMA. 2018;319(12):1221-38.

High-dose oral ibuprofen may be most likely to result in closure of hemodynamically significant patent ductus arteriosus (PDA) in preterm infants, compared with other pharmacological treatments, according to results of a recent systematic review and meta-analysis.

However, using placebo or no treatment at all did not increase the odds of mortality, necrotizing enterocolitis, or intraventricular hemorrhage in the study, published in JAMA.

herjua/Thinkstock

They found that closure of hemodynamically significant PDA was significantly more likely with high-dose oral ibuprofen, compared with the two of the most widely used treatments, namely standard-dose intravenous ibuprofen (odds ratio, 3.59) and standard-dose intravenous indomethacin (odds ratio, 2.35).

Despite that finding, there was no significant difference in the odds of mortality, necrotizing enterocolitis, or intraventricular hemorrhage for use of placebo or no treatment, compared with any of the treatment modalities, the investigators added.

“With increasing emphasis on conservative management of PDA, these results may encourage researchers to revisit placebo-controlled trials against newer pharmacotherapeutic options,” they said.

Study authors reported no relevant potential conflicts of interest.

SOURCE: Mitra S et al. JAMA. 2018;319(12):1221-38.

High-dose oral ibuprofen may be most likely to result in closure of hemodynamically significant patent ductus arteriosus (PDA) in preterm infants, compared with other pharmacological treatments, according to results of a recent systematic review and meta-analysis.

However, using placebo or no treatment at all did not increase the odds of mortality, necrotizing enterocolitis, or intraventricular hemorrhage in the study, published in JAMA.

herjua/Thinkstock

They found that closure of hemodynamically significant PDA was significantly more likely with high-dose oral ibuprofen, compared with the two of the most widely used treatments, namely standard-dose intravenous ibuprofen (odds ratio, 3.59) and standard-dose intravenous indomethacin (odds ratio, 2.35).

Despite that finding, there was no significant difference in the odds of mortality, necrotizing enterocolitis, or intraventricular hemorrhage for use of placebo or no treatment, compared with any of the treatment modalities, the investigators added.

“With increasing emphasis on conservative management of PDA, these results may encourage researchers to revisit placebo-controlled trials against newer pharmacotherapeutic options,” they said.

Study authors reported no relevant potential conflicts of interest.

SOURCE: Mitra S et al. JAMA. 2018;319(12):1221-38.