medwireNews: Treatment with biologic DMARDs may increase the likelihood of remission almost fourfold in patients with axial spondyloarthritis (axSpA) relative to placebo, but more trials assessing remission-like outcomes are needed, say researchers.
In their systematic review and meta-analysis, Ana Rita Cruz-Machado (Hospital de Santa Maria, Lisbon, Portugal) and colleagues identified 22 randomized controlled trials (RCTs) and 28 long-term extension studies that used ASAS partial remission (ASAS-PR) and/or ASDAS inactive disease (ASDAS-ID) as surrogate markers for remission.
The studies included 5352 adults with radiographic or nonradiographic axSpA who received any biologic DMARD versus placebo and/or a comparator drug.
The researchers found that ASAS-PR was the most commonly used outcome, reported in 20 of the 22 RCTs and defined as a score of 2 points or less on each of the four domains. ASDAS-ID (score <1.3 points) was used as an outcome in four studies, two as an exclusive measure and two in conjunction with ASAS-PR. The majority (n=21) of the trials used these endpoints as secondary outcome measures.
Tumor necrosis factor (TNF) inhibitors were the most common drugs evaluated, comprising 17 trials (most commonly etanercept and adalimumab). Four trials involved interleukin (IL)-17A inhibitors (three secukinumab, one ixekizumab) and one trial assessed the IL-6 receptor inhibitor sarilumab.
As reported in Rheumatology, the majority (82.4%) of TNF inhibitor trials showed evidence of treatment efficacy in terms of achieving remission for radiographic or non-radiographic axSpA. At 12 weeks the ASAS-PR rate ranged from 16.0% to 31.6%, at 16 weeks it was 33.0% to 55.6%, at 24 weeks it was 17.0% to 22.4%, and in the one trial that reported data for 28 weeks the ASAS-PR rate was 61.9%.
The three 12-week trials that reported ASDAS-ID had remission rates of 24.0–40.2%.
The limited data for IL-17A inhibitors showed 16-week remission rates of 15.0–21.1% for ASAS-PR, all with secukinumab, and 11.0–16.0% for ASDAS-ID with ixekizumab. ASAS-PR was not reached in the only trial involving sarilumab.
The researchers then conducted a meta-analysis of 15 studies with similar duration (12, 16, or 24 weeks), which showed that individuals in the active treatment group were a significant 3.9 times more likely to achieve ASAS-PR than those in the placebo group.
They also calculated that the number needed to treat to achieve ASAS-PR in one patient ranged from 2.5 to 9.0 for TNF inhibitors and from 8.4 to 12.3 for IL-17A inhibitors.
In addition, Cruz-Machado and co-authors comment that the “RCT extensions provided evidence for the sustained efficacy of [biologic] DMARDs in achieving remission, although long-term data concerning ixekizumab, recently approved by the [US] FDA , are needed.”
The team concludes: “Our meta-analysis showed that [biologic] DMARDs have a clear impact in axSpA remission evaluated by ASAS-PR.
“Nevertheless, considering currently aimed treatment targets, these data show an unmet need for improved reporting of remission-like outcomes and treatment options favouring optimized remission rates in axSpA patients.”
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