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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In patients with ulcerative colitis (UC), tofacitinib, a Janus kinase inhibitor, was associated with improved short-term efficacy, when compared with vedolizumab, an integrin receptor antagonist. Findings were presented at the Advances in Inflammatory Bowel Disease (AIBD) 2019 meeting in Orlando, Florida.
Treatment with tofacitinib appears to have little impact on extraintestinal manifestations (EIMs) in patients with moderate to severe ulcerative colitis (UC) and might even improve them, according to an analysis of the OCTAVE program. Findings were presented at the 2019 AIBD Annual Meeting in Orlando, Florida.
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).
The clinical benefits of tofacitinib in combination with methotrexate are sustained over 2 years among patients with rheumatoid arthritis (RA), according to a study published online January 22 in Arthritis & Rheumatology.
Although the incidence rate of venous thromboembolism was numerically higher in patients treated with tofacitinib vs TNF inhibitors, the risk was not statistically significant.
The results support combination therapy with intra-articular steroid injections and tofacitinib to achieve clinical and radiographic remission in patients with early rapid radiographic progression RA.