Etanercept is effective as monotherapy or in combination with methotrexate in rheumatoid arthritis: subanalysis of an observational study

Abstract

Approximately 30% of patients with rheumatoid arthritis receiving biological disease-modifying antirheumatic drugs (bDMARDs) take them as monotherapy. Although etanercept (ETN) monotherapy has been evaluated in clinical trials, data in the real-world setting are sparse. We compared the efficacy and safety of ETN, given alone or in combination with methotrexate (MTX), in routine clinical practice. This was a subanalysis of patients who received either ETN alone or ETN + MTX during a 52-week prospective, observational study conducted at 329 German centers. The primary endpoint was "Funktionsfragebogen Hannover" (Hannover Functional Ability Questionnaire [FFbH]; low FFbH = worse function) functional remission at week 26 and week 52. Secondary endpoints included the 28-joint count Disease Activity Score (DAS28), DAS28 remission (DAS28 < 2.6), and adverse events (AEs). Participating centers applied ETN monotherapy in 43.1% of patients and ETN + MTX in 56.9%. A smaller proportion of patients achieved FFbH functional remission with ETN vs ETN + MTX (31.9%, 95% confidence interval [CI] 29.1-34.9% vs 39.8%, 37.2-42.5%, respectively; p < 0.001) at 26 weeks and at 52 weeks (38.4%, 35.1-41.7% vs 44.3%, 41.5-47.2%, respectively; p = 0.007). After 52 weeks, the mean DAS28 (±SD) decreased from 5.5 ± 1.3 to 3.4 ± 1.4 (ETN) vs 5.3 ± 1.3 to 3.2 ± 1.3 (ETN + MTX) and DAS28 remission was achieved by 32.5% (95% CI 29.0-36.1%) of patients with ETN vs 38.8% (35.8-41.9%; p = 0.007) with ETN + MTX. Overall, 20.6 (ETN) and 19.7% (ETN + MTX) of patients reported treatment-related AEs. Patients received ETN monotherapy almost as often as ETN + MTX. ETN + MTX appeared marginally more effective than ETN monotherapy in some, but not all, outcomes measured.

Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany

“…They were higher compared to a recent large observational study in RA with another biologic which used the FFbH as primary endpoint (mean score at 1 year was approximately 65 points) [33]. …”

“…The FFbH has been shown earlier to be a reliable and valid instrument for measuring functional disability in a German-speaking population with RA [ 24 ] In all groups in GO-NICE, scores increased in a clinically relevant manner by the end of the study. They were higher compared to a recent large observational study in RA with another biologic which used the FFbH as primary endpoint (mean score at 1 year was approximately 65 points) [ 33 ].…”

Effectiveness of Etanercept in Rheumatoid Arthritis: Real-World Data from the German Non-interventional Study ADEQUATE with Focus on Treat-to-Target and Patient-Reported Outcomes

“…While clinical trials like COMET are paramount in investigating the efficacy and safety of treatments in a controlled manner, real-world studies and registry data analyses (e.g., RABBIT [ 7 ]) offer insight into patient outcomes in routine practice [ 8 , 9 ]. The non-interventional ADEQUATE study evaluated the effectiveness of ETN over a period of 12 months in the routine treatment of patients with rheumatic diseases and plaque psoriasis, with particular attention to patients who attained their desired treatment goal after more than 12 weeks of treatment.…”

Current Therapeutic Options in the Treatment of Rheumatoid Arthritis

“…Only certolizumab, adalimumab, and etanercept are approved as monotherapy as well as in combination with methotrexate [27,28,29,30,31].…”