Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis (RA): A Retrospective Study From Two Centers in Jeddah, Saudi Arabia.

Background: Tofacitinib is the first Janus kinase (JAK) inhibitor approved for treating rheumatoid arthritis (RA). Several clinical trials have evaluated the safety and effectiveness of tofacitinib in adult patients with moderately to severely active RA. Real-world studies provide invaluable insights into routine clinical practice. We aim to assess the clinical efficacy and safety of RA patients.

Methods: Over a period of two years, we included 50 consecutive RA patients who were treated with tofacitinib. Clinical disease activity, assessed by disease activity score (DAS) 28 - erythrocyte sedimentation rate (ESR), as well as adverse events (AEs) were evaluated.

Results: A total of 50 patients (84% female) were enrolled in the study. The mean age at initiation of tofacitinib was 48.54 ± 15.97 years. The mean time of treatment with tofacitinib was 18.06 ± 2.04 months. Patients were treated with tofacitinib 5 mg BID with 32% receiving tofacitinib as monotherapy. A total of 74% of the patients had been prescribed at least one biological treatment. The treatment target was achieved in 42 patients (82%). Baseline characteristics and previous treatment regimens did not predict clinical response to tofacitinib. Fifteen patients discontinued the treatment: seven due to ineffectiveness, four due to pregnancy, and five due to adverse events. The most common infectious adverse event was herpes zoster (4%) while the most common observed laboratory abnormalities were elevation in low density lipoprotein (LDL) and high density lipoprotein (HDL) in 6% and 8% of the patients, respectively.

Conclusion: Our results indicate that tofacitinib is effective in real-world settings even as monotherapy. The treatment target was attained by 82% of the patients on tofacitinib. The safety profile of tofacitinib was generally consistent with previous studies.