The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
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Researchers compared the risk for serious infections in offspring of mothers with chronic inflammatory diseases who received non-TNFi biologics or tofacitinib during pregnancy vs offspring who were unexposed, but exposed to TNFi in utero.
The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen. The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).
Case reports describe repigmentation of vitiligo with facial involvement in Hispanic woman, white man
Tofacitinib is superior for patients with inadequate response to TNF inhibitors or conventional DMARDs
The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.
The researchers found that significantly more patients receiving tofacitinib 5mg and tofacitinib 10mg versus placebo achieved a ≥50% reduction in the Nail Psoriasis Severity Index (NAPSI) score from baseline (NAPSI50)
A total of 18.5% patients taking tofacitinib experienced a remission of their condition in 8 weeks compared to just 8.2% of patients receiving placebo.