No significant differences were found between patients with psoriatic arthritis (PsA) who were given etanercept and methotrexate combination therapy or etanercept monotherapy, according to results published in Arthritis & Rheumatology.
Researchers conducted a phase 3, randomized, double-blind, multicenter study of 851 patients with PsA. Study patients were randomly assigned to receive weekly doses of etanercept 50 mg plus placebo (n=284), oral methotrexate 20 mg plus etanercept 50 mg (n=283), or oral methotrexate 20 mg plus placebo (n=284) for a total of 48 weeks. The primary outcome measured was the minimal disease activity (MDA) and American College of Rheumatology 20% (ACR20) responses after 24 weeks.
After analysis, the researchers found that response scores at week 24 were significantly higher for etanercept monotherapy compared with methotrexate monotherapy (ACR20, 60.9% vs 50.7%; P =.029; MDA, 35.9% vs 22.9%; P =.005). In addition, they saw similar results for etanercept plus methotrexate combination therapy compared with methotrexate monotherapy (ACR20, 65.0% vs 50.7%; P =.005; MDA, 35.7% vs 22.9%; P =.005).
The primary limitation of the study was the lack of a placebo group, which limits the generalizability of the results.
“These results provide information that [is] of practical value for clinical practice about the relative efficacy of methotrexate and etanercept and the impact of combining methotrexate and etanercept across a broad range of PsA clinical manifestations,” the researchers wrote.
“Overall, combining methotrexate and etanercept did not improve etanercept efficacy,” they concluded.
Mease PJ, Gladman DD, Collier DH, et al. Etanercept and methotrexate as monotherapy or in combination for psoriatic arthritis: primary results from a randomized, controlled phase 3 trial [published online February 12, 2019]. Arthritis Rheumatol. doi: 10.1002/art.40851