Review: Biologic Monotherapy Compared to Traditional DMARDs for RA
According to data from a Cochrane review in patients with rheumatoid arthritis (RA) who had previously tried and failed treatment with methotrexate/other disease-modifying anti-rheumatic drugs (DMARDs), biologic monotherapy improved American College of Rheumatology score (ACR50) function and RA remission rates vs. placebo or methotrexate/other DMARDs.
Researchers conducted a systematic review, a standard meta-analysis, and network meta-analysis (NMA) as an update to the 2009 Cochrane Overview "Biologics for rheumatoid arthritis." The analysis focused on comparing the benefits and risks of biologic monotherapy, which included anti-tumor necrosis factor (TNF) agents (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab) or non-TNF agents (eg, abatacept, anakinra, rituximab, tocilizumab) or tofacitinib monotherapy vs. placebo or methotrexate/other DMARDs. A total of 46 randomized controlled trials were identified, 41 of which provided data (n=14,049). For 16 trials, the comparator was placebo; for 13 trials, methotrexate/other DMARDs; and for 12 trials, another biologic.
Biologic monotherapy without concomitant methotrexate/other DMARDs was associated with a clinically meaningful and statistically significant improvement in the ACR50 (risk ratio [RR] 4.68, 95% CI: 2.93–7.48) and physical function, as measured by the Health Assessment Questionnaire (HAQ) vs. placebo (mean difference [MD] -0.32, 95% CI: -0.42 to -0.23). This was based on moderate-quality direct evidence.
Biologic monotherapy was also tied to a clinically meaningful and statistically significant greater proportion of disease remission vs. placebo (RR 1.12, 95% CI: 1.03–1.22). This was based on moderate-quality direct evidence.
Biologic monotherapy without concomitant methotrexate/other DMARDs was associated with a clinically meaningful and statistically significant improvement in ACR50 and HAQ scores vs. methotrexate/other DMARDs (RR 1.54, 95% CI: 1.14–2.08). Direct and NMA estimates for TNF monotherapy and NMA estimate for non-TNF biologic monotherapy for ACR50 showed comparable results. This was based on moderate-quality evidence.
Study authors found no statistically significant or clinically meaningful differences for direct estimates of biologic monotherapy vs. active comparator for RA disease remission. A statistically significant and clinically meaningful difference vs. active comparator for TNF monotherapy (absolute improvement 7%) and non-TNF monotherapy (absolute improvement 19%) was seen in NMA estimates. This was based on moderate-quality evidence.
One study found a statistically significant reduction in radiographic progression in patients on biologic monotherapy vs. active comparator (mean difference -4.34, 95% CI: -7.56 to -1.12) though the absolute reduction was small (-0.97%, 95% CI: -1.69% to -0.25%).
Results were inconclusive as to whether biologic monotherapy was linked to increased withdrawals due to adverse events, serious adverse events, or cancer compared to placebo or methotrexate/other DMARDs.
The review, based primarily on 6- to 12-month randomized controlled trials, found that biologic monotherapy improved ACR50, function and RA remission rates vs. placebo or methotrexate/other DMARDs in patients with RA who previously failed treatment with methotrexate/other DMARDs.
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