The most common non-serious side effects in patients taking tofacitinib were a headache and diarrhea. A similar number of patients with RA or PsA taking tofacitinib or placebo had non-serious side effects. Here we looked at patients with RA or PsA who were taking tofacitinib or placebo (no medicine) during clinical trials, to find out how often they had certain non-serious side effects, how long they lasted, and whether they caused the patients to stop taking their medication. Serious side effects that might occur in patients taking tofacitinib are more frequently discussed than the mild, non-serious side effects that patients might consider to be more of a ‘nuisance’, which often occur shortly (< 3 months) after starting treatment. Tofacitinib is a medicine that can be taken by patients to treat rheumatoid arthritis (RA) or psoriatic arthritis (PsA). Most events were mild or moderate and generally resolved within 4 weeks. Non-serious AE incidence was generally similar in patients with RA or PsA receiving tofacitinib or placebo. The most frequent cause of temporary discontinuation across all groups was gastric discomfort (0.3–0.8%). Permanent discontinuations due to non-serious AEs were not observed in patients with PsA, and were < 1.0% in patients with RA across treatment groups. Most events were mild or moderate in severity, lasting ≤ 4 weeks. The most frequent non-serious AEs were headache and diarrhea with tofacitinib, and dyspepsia, nausea, and headache with placebo. Incidence of non-serious AEs to month 3 was generally similar with tofacitinib and placebo. We analyzed 3871 and 710 patients with RA and PsA, respectively. Select all-causality, non-serious AEs, reported to month 3 (placebo-controlled period), were headache, diarrhea, nausea, vomiting, and gastric discomfort (including dyspepsia, gastritis, epigastric discomfort, and abdominal discomfort or pain) incidence rates (unique patients with events per 100 patient-years of follow-up), duration of, and discontinuations due to these non-serious AEs were reported. Methodsĭata were pooled from five phase 3 and one phase 3b/4 studies in patients with moderate-to-severe RA, and two phase 3 studies in patients with active PsA. This post hoc analysis assessed frequency or duration of early select non-serious adverse events (AEs excluding infections), and their impact on treatment discontinuation, in patients with RA or PsA treated with tofacitinib 5 or 10 mg twice daily, or placebo. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
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