Tofacitinib is associated with rapid and sustained improvements across multiple pain measures in patients with inflammatory rheumatic and musculosketal diseases, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS), according to study results published in RMD Open.
In this post hoc analysis of randomized controlled trials, researchers used data from double-blind placebo-controlled studies that evaluated the effect of twice-daily 5 mg or 10 mg tofacitinib on pain reported by patients with diagnoses of active RA, PsA, or AS at screening (n=3330). There were 4 studies that lasted for 6 to 24 months in RA, 2 that lasted for 6 to 12 months in PsA, and a phase 2 study for AS that lasted for 12 weeks. Patients from all randomized controlled trials were grouped into 5 analysis populations according to their disease and inadequate response to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), tumor necrosis factor inhibitors (TNFi), or nonsteroidal anti-inflammatory drugs (NSAIDs). Assessment of arthritis pain score was used to record patient-reported pain.
In the RA and PsA analysis populations, most patients were receiving methotrexate, and in the AS population, most patients were receiving concomitant NSAIDs. Results showed significant reductions in least squares mean change from baseline to the earliest time points assessed in evaluating arthritis pain scores in patients with RA and PsA who had an inadequate response to csDMARDs and TNFis. In patients with AS who had an inadequate response to NSAIDs, the least squares mean change was significantly greater with either the 5 mg or 10 mg dose of tofacitinib compared with placebo at week 12 (both P <.01).
Study limitations included difficulty in measuring pain that incorporates both inflammatory and noninflammatory concepts. The comparison and interpretation of these results was limited by the lack of confirmation of axial spondyloarthropathy in patients with PsA, the small AS population, and differing time points across study populations. Researchers focused on statistical significance of patient-reported pain improvements rather than assessing similarities between levels of improvement across diseases. A more formal meta-analysis was not feasible or practical because of the varying study designs included in this analysis.
The findings of this study demonstrated that tofacitinib was associated with consistent alleviation of pain in patients with RA, PsA, and AS. The improvements appeared to continue irrespective of tofacitinib dose or previous unsuccessful treatment with csDMARDs, TNFi, or NSAIDs. “The experience of pain may be different between patients with RA, PsA or AS, [because of] the distinctive phenotypes and clinical pattern of presentation,” the researchers noted. “Specific to the AS population, it remains a challenge to confirm inflammatory back pain, as this is assessed solely based on patient input. Further studies are needed to understand the mechanisms of pain in rheumatic diseases, how they differ between these diseases, and how best to treat pain.”
Disclosure: This study was supported in part by Pfizer, Inc. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Ogdie A, de Vlam K, McInnes IB, et al. Efficacy of tofacitinib in reducing pain in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis [published online February 3, 2020]. RMD Open. doi:10.1136/rmdopen-2019-001042