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LISBON – Adding methotrexate to etanercept in patients with moderate to severe plaque psoriasis brings a bump in efficacy with no increase in serious adverse events, according to a large, double-blind, randomized clinical trial.
The multicenter trial included 478 patients on etanercept (Enbrel) at 50 mg twice weekly for 12 weeks, followed by once-weekly treatment thereafter. Participants were randomized to methotrexate or placebo from the outset. Methotrexate was dosed at 7.5 mg/week for the first 2 weeks, 10 mg/week for the next 2 weeks, and 15 mg/week after that.
The primary study end point was the proportion of patients attaining a PASI 75 response – that is, at least a 75% improvement over baseline scores on the Psoriasis Area and Severity Index – at week 24. The PASI 75 rate was 77.3% with dual therapy, significantly better than the 60.3% rate with etanercept alone, Dr. Alice B. Gottlieb reported at the annual congress of the European Academy of Dermatology and Venereology.
These results with combination therapy are in line with the enhanced efficacy seen with ustekinumab (Stelara) and other biologics targeting interleukin-23/Th17. But the combination therapy relies upon familiar medications that have been around a long time and have well-understood safety profiles, she noted.
The 24-week PASI 90 rate was also markedly better with dual therapy: 53.8%, compared with 34.2%. Seventy-two percent of patients on methotrexate plus etanercept were rated clear or almost clear on Physician’s Global Assessment, as were 53% on etanercept alone, according to Dr. Gottlieb, professor and chair of dermatology at Tufts Medical Center, Boston.
Adding methotrexate accelerated the time course of improvement. By week 12, 70% of patients on methotrexate plus etanercept had achieved a PASI 75 response, compared with 54% of those on etanercept alone.
Three serious adverse events occurred in each study arm. In the dual-therapy arm, there was one case each of bacterial pneumonia, lumbar spinal stenosis, and synovial cyst. In the etanercept-only arm, there was a case of acute MI, cholecystitis, and asthma.
Dr. Gottlieb disclosed that she serves as a consultant to Amgen, which sponsored the trial. In addition, she is a consultant and/or advisory board member for numerous other pharmaceutical companies.
LISBON – Adding methotrexate to etanercept in patients with moderate to severe plaque psoriasis brings a bump in efficacy with no increase in serious adverse events, according to a large, double-blind, randomized clinical trial.
The multicenter trial included 478 patients on etanercept (Enbrel) at 50 mg twice weekly for 12 weeks, followed by once-weekly treatment thereafter. Participants were randomized to methotrexate or placebo from the outset. Methotrexate was dosed at 7.5 mg/week for the first 2 weeks, 10 mg/week for the next 2 weeks, and 15 mg/week after that.
The primary study end point was the proportion of patients attaining a PASI 75 response – that is, at least a 75% improvement over baseline scores on the Psoriasis Area and Severity Index – at week 24. The PASI 75 rate was 77.3% with dual therapy, significantly better than the 60.3% rate with etanercept alone, Dr. Alice B. Gottlieb reported at the annual congress of the European Academy of Dermatology and Venereology.
These results with combination therapy are in line with the enhanced efficacy seen with ustekinumab (Stelara) and other biologics targeting interleukin-23/Th17. But the combination therapy relies upon familiar medications that have been around a long time and have well-understood safety profiles, she noted.
The 24-week PASI 90 rate was also markedly better with dual therapy: 53.8%, compared with 34.2%. Seventy-two percent of patients on methotrexate plus etanercept were rated clear or almost clear on Physician’s Global Assessment, as were 53% on etanercept alone, according to Dr. Gottlieb, professor and chair of dermatology at Tufts Medical Center, Boston.
Adding methotrexate accelerated the time course of improvement. By week 12, 70% of patients on methotrexate plus etanercept had achieved a PASI 75 response, compared with 54% of those on etanercept alone.
Three serious adverse events occurred in each study arm. In the dual-therapy arm, there was one case each of bacterial pneumonia, lumbar spinal stenosis, and synovial cyst. In the etanercept-only arm, there was a case of acute MI, cholecystitis, and asthma.
Dr. Gottlieb disclosed that she serves as a consultant to Amgen, which sponsored the trial. In addition, she is a consultant and/or advisory board member for numerous other pharmaceutical companies.
LISBON – Adding methotrexate to etanercept in patients with moderate to severe plaque psoriasis brings a bump in efficacy with no increase in serious adverse events, according to a large, double-blind, randomized clinical trial.
The multicenter trial included 478 patients on etanercept (Enbrel) at 50 mg twice weekly for 12 weeks, followed by once-weekly treatment thereafter. Participants were randomized to methotrexate or placebo from the outset. Methotrexate was dosed at 7.5 mg/week for the first 2 weeks, 10 mg/week for the next 2 weeks, and 15 mg/week after that.
The primary study end point was the proportion of patients attaining a PASI 75 response – that is, at least a 75% improvement over baseline scores on the Psoriasis Area and Severity Index – at week 24. The PASI 75 rate was 77.3% with dual therapy, significantly better than the 60.3% rate with etanercept alone, Dr. Alice B. Gottlieb reported at the annual congress of the European Academy of Dermatology and Venereology.
These results with combination therapy are in line with the enhanced efficacy seen with ustekinumab (Stelara) and other biologics targeting interleukin-23/Th17. But the combination therapy relies upon familiar medications that have been around a long time and have well-understood safety profiles, she noted.
The 24-week PASI 90 rate was also markedly better with dual therapy: 53.8%, compared with 34.2%. Seventy-two percent of patients on methotrexate plus etanercept were rated clear or almost clear on Physician’s Global Assessment, as were 53% on etanercept alone, according to Dr. Gottlieb, professor and chair of dermatology at Tufts Medical Center, Boston.
Adding methotrexate accelerated the time course of improvement. By week 12, 70% of patients on methotrexate plus etanercept had achieved a PASI 75 response, compared with 54% of those on etanercept alone.
Three serious adverse events occurred in each study arm. In the dual-therapy arm, there was one case each of bacterial pneumonia, lumbar spinal stenosis, and synovial cyst. In the etanercept-only arm, there was a case of acute MI, cholecystitis, and asthma.
Dr. Gottlieb disclosed that she serves as a consultant to Amgen, which sponsored the trial. In addition, she is a consultant and/or advisory board member for numerous other pharmaceutical companies.
FROM THE ANNUAL CONGRESS OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY
Major Finding: Adding methotrexate to etanercept resulted in a 77% PASI 75 response rate at 24 weeks, compared with 60% with etanercept alone.
Data Source: A double-blind, randomized, placebo-controlled clinical trial involving 478 patients with moderate to severe plaque psoriasis.
Disclosures: Dr. Gottlieb disclosed that she serves as a consultant to Amgen, which sponsored the trial. In addition, she is a consultant and/or advisory board member for numerous other pharmaceutical companies.