A retrospective chart review to explore the efficacy and safety of switching to peficitinib in Japanese patients with rheumatoid arthritis and inadequate response to biologic disease-modifying antirheumatic drugs.

OBJECTIVES

This retrospective, observational study examined the safety and efficacy of the Janus kinase inhibitor peficitinib in Japanese patients with rheumatoid arthritis who switched to peficitinib due to inadequate response to biologic disease-modifying antirheumatic drugs.

METHODS

We included patients aged ≥ 20 years with rheumatoid arthritis who switched to peficitinib between 10 July 2019 and 31 March 2022 and were enrolled in peficitinib post-marketing surveillance. The primary endpoint was change in disease activity score in 28 joints with erythrocyte sedimentation rate (DAS28-ESR) from index date to 24 weeks. Secondary endpoints included change in Clinical Disease Activity Index and adverse event incidence.

RESULTS

Of 76 enrolled patients, efficacy data were available for 67; 56 completed 24 weeks of treatment. One-quarter (19/76) of patients reported adverse events; 16 (21.1%) had drug-related adverse events with one (streptococcal infection) considered serious. From index date to 24 weeks, mean (standard deviation) change in DAS28-ESR was -0.95 (1.24) (95% confidence interval [CI]: -1.26, -0.65; P < .0001) and in Clinical Disease Activity Index was -7.82 (8.52) (95% CI: -9.90, -5.74; P < .0001). Improvements in DAS28-ESR and Clinical Disease Activity Index by 12 and 24 weeks were statistically significant regardless of prior number of biologic disease-modifying antirheumatic drugs.

CONCLUSIONS

Peficitinib could be an effective treatment option for patients with rheumatoid arthritis refractory to biologic disease-modifying antirheumatic drugs.