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Phase 3 data support etanercept monotherapy for PsA
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CHICAGO — Phase 3 data from the SEAM-PsA study presented at the ACR/ARHP 2018 Annual Meeting showed that etanercept alone or in combination with methotrexate was effective against psoriatic arthritis and superior to methotrexate alone.
The trial is the first head-to-head comparison of methotrexate and a TNF inhibitor and addresses “fundamental questions” about PsA management, according to Philip J. Mease, MD, lead investigator and clinical professor at the University of Washington.
“These results provide information of practical value for PsA patients and their physicians to optimally manage the disease while addressing potential challenges associated with combination therapy,” he said in a press release.
For the trial, Mease and colleagues randomly assigned 851 patients with early PsA disease who were not previously treated with biologics and methotrexate to one of three treatment groups for 48 weeks: 50 mg of etanercept (Enbrel, Amgen) plus 20 mg of methotrexate each week (n = 283); 50 mg of etanercept plus oral placebo each week (n = 284); or 20 mg of methotrexate plus injectable placebo each week (n = 284). The primary endpoint was ACR20 response at week 24. Secondary endpoints included Minimal Disease Activity (MDA), ACR50 and ACR70 responses.
According to the results, 60.9% of patients in the etanercept monotherapy arm and 65% in the etanercept plus methotrexate combination therapy arm achieved ACR20 responses at week 24 compared with 50.7% of patients in the methotrexate monotherapy arm. In addition, significantly more patients in the etanercept monotherapy arm and etanercept combination arm achieved an MDA response compared with patients in the methotrexate monotherapy arm (35.9% and 35.7% vs. 22.9%).
Patients who received etanercept monotherapy or combination therapy also had greater ACR50 responses (44.4% and 45.7% vs. 30.6%) and ACR70 responses (29.2% and 27.7% vs. 13.8%).
The incidence of adverse events was similar across the treatment groups, with no new safety signals identified. Adverse events that occurred in 5% or more of patients receiving etanercept were nausea, nasopharyngitis, upper respiratory tract infection, headache and bronchitis.
There was no prespecified analysis comparing etanercept monotherapy and combination therapy with methotrexate. However, Mease said in the release that both regimens had “generally similar efficacy.”
“Addition of methotrexate to etanercept did not appear to improve efficacy,” Mease and colleagues wrote in the abstract. “These results support the use of etanercept as monotherapy for PsA.” – by Stephanie Viguers
References:
Amgen. First Head-to-Head Trial of a TNF Inhibitor Versus Methotrexate Monotherapy in Psoriatic Arthritis Shows ENBREL® (Etanercept) Monotherapy and Combination Therapy Both Superior to Methotrexate. https://www.amgen.com/media/news-releases/2018/10/first-headtohead-trial-of-a-tnf-inhibitor-versus-methotrexate-monotherapy-in-psoriatic-arthritis-shows-enbrel-etanercept-monotherapy-and-combination-therapy-both-superior-to-methotrexate/. Accessed Dec. 11, 2018.
Mease PJ, et al. Abstract L11. Presented at: ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.
Disclosure: Mease reports receiving research grants from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Novartis, Pfizer, SUN and UCB; consulting fees or other payments from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, SUN and UCB; and speakers’ bureau fees from Abbvie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer and UCB.