Tofacitinib is a Janus kinase inhibitor that is taken orally and is used to treat rheumatoid arthritis (RA). Researchers conducted a thorough analysis of phase 3 trials of tofacitinib 5 mg twice daily (BID) (an authorized dosage in several countries) in patients with moderate to severe RA who had previously failed to respond to disease-modifying antirheumatic medications. A PubMed and ClinicalTrials.gov search yielded five studies: ORAL Solo (NCT00814307), ORAL Sync (NCT00856544), ORAL Standard (including adalimumab 40 mg once every two weeks; NCT00853385), ORAL Scan (NCT00847613), and ORAL Step (NCT00847613) (NCT00960440). Tofacitinib 5 mg BID, placebo, and adalimumab efficacy and safety data were examined.
In the five investigations, 1,216 patients were given tofacitinib 5 mg BID, 681 were given a placebo, and 204 were given adalimumab. At month 3, Tofacitinib demonstrated significantly higher 20%, 50%, and 70% improvement in American College of Rheumatology response criteria (ACR20, ACR50, and ACR70, respectively) response rates, greater improvement in Health Assessment Questionnaire-Disability Index, and a higher proportion of Disease Activity Score-defined remission than placebo. At month 3, the frequency of adverse events (AEs), severe AEs, and discontinuations due to AEs were comparable for tofacitinib and placebo; serious infection events were more common for tofacitinib. Tofacitinib 5 mg and adalimumab exhibited numerically equivalent effectiveness and AEs in ORAL Standard, although not being powered for formal comparisons; severe AEs and serious infection events were more common with tofacitinib.
Tofacitinib 5 mg BID decreased RA symptoms and improved physical performance compared to placebo in individuals who had previously failed to respond to disease-modifying antirheumatic medications. Tofacitinib 5 mg BID demonstrated a similar, manageable safety profile across studies, with no new safety signals discovered.
Reference:journals.lww.com/jclinrheum/Fulltext/2019/04000/Tofacitinib_5_mg_Twice_Daily_in_Patients_with.1.aspx
