Abstract
To assess the efficacy and safety of jakinibs for the treatment of active rheumatoid arthritis (RA) in patients with an inadequate response or intolerance to conventional synthetic or biologic disease-modifying antirheumatic drugs (DMARDs). A systematic search was conducted in PubMed, Embase, and the Cochrane Library. Randomized placebo-controlled trials (RCTs) of jakinibs in RA patients were eligible. The effective outcome was RA improvement to reach an American College of Rheumatology 20%/50%/70% (ACR20/50/70) response rate at weeks 12 and 24 after treatment. The safety outcomes included treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuations due to adverse events, infections, and serious infections. Twenty-eight randomized, double-blind, controlled trials including 14,500 patients were included. At both weeks 12 and 24, the pooled analysis suggested effective treatment with jakinibs, represented as an increased clinical response of ACR20, ACR50, and ACR70. Subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12. Jakinibs were associated with an increased incidence of infections at week 12 and TEAEs and infections at week 24. No increase in the risk of SAEs, discontinuations due to adverse events, or serious infections was observed in comparisons between treatment with jakinibs and treatment with placebo in these patients. Jakinibs are efficacious and well tolerated in RA patients up to 24 weeks, although they are associated with an increased risk of infectious complications. Key Points • ACR20/50/70 in patients treated with jakinibs was significantly higher than those in patients treated with placebo. • No difference in ACR50/70 was observed in patients with RA treated with peficitinib and placebo. • Jakinibs are beneficial and well tolerated in RA treatment.
Highlights
Rheumatoid arthritis (RA) is a systemic, chronic and progressive inflammatory disease with a prevalence of approximately 5 per 1000 adults worldwide [1]
Twenty-eight randomized, double-blind, controlled trials including 14500 patients were included. Both at week 12 and 24, the pooled analysis was suggestive of an effective treatment with jakinibs, represented as the increased clinical response of American College of Rheumatology 20% improvement criterion (ACR20), ACR50 and ACR70
The subgroup analysis based on different types of jakinibs demonstrated that only peficitinib treatment had no impact on the clinical response of ACR50 or ACR70 at week 12
Summary
Rheumatoid arthritis (RA) is a systemic, chronic and progressive inflammatory disease with a prevalence of approximately 5 per 1000 adults worldwide [1]. RA primarily affects peripheral joints, leading to synovitis as well as cartilage damage and bone erosion, and increases disability and mortality for affected patients [2]. The treatment of RA is based on conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), especially the anchor drug, methotrexate [3]. During the past two decades, various options, especially biologic DMARDs (bDMARDs), such as tumor necrosis factor (TNF) inhibitors available for the treatment of RA, have been developed [4]. Current studies have demonstrated that an American College of Rheumatology 20% improvement criterion (ACR20) cannot be achieved in up to 40% of RA patients treated with TNF inhibitors in a long-term follow-up [6]. It seems necessary to explore more options with mechanisms of action that are different from those of the currently used csDMARDs and biologics
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