News
Tofacitinib vs TNFi for RA: Safety Study Results Announced
The randomized phase 3b/4 ORAL Surveillance study included 4362 RA patients who were taking methotrexate without adequate control of symptoms.
Your search for tofacitinib returned 39 results
News
Xeljanz Approved for Active Polyarticular Course Juvenile Idiopathic Arthritis
Patients treated with tofacitinib experienced significantly fewer disease flares compared with placebo.
News
Successful Treatment of Long-Term Eosinophilic Esophagitis With JAK Inhibitor
Several treatments were attempted but failed to manage the patient’s conditions, including proton pump inhibitors, topical steroids, a restricted diet, and infliximab (3 doses) for arthritis.
News
Xeljanz XR Approved for Ulcerative Colitis
The FDA has approved Xeljanz XR (tofacitinib extended-release; Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis.
Safety Alerts and Recalls
Boxed Warning Added to Tofacitinib Prescribing Information
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…
Drugs in the Pipeline, News
Tofacitinib Ext-Rel Monotherapy Effective for Moderate to Severe RA After Methotrexate Withdrawal
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
News
JAK Inhibitors Evaluated for Crohn Disease, Ulcerative Colitis Treatment
Although found to increase the risk of infectious complications, janus kinase (JAK) inhibitors effectively induce clinical remission in patients with Crohn disease (CD) and clinical and endoscopic remission in patients with ulcerative colitis (UC), according to results of a recently published systematic review and meta-analysis.
Safety Alerts and Recalls
Increased Risk of Pulmonary Embolism, Death in RA Patients Reported in Tofacitinib Postmarketing Study
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).
Drugs in the Pipeline
Upadacitinib Gets FDA’s Priority Review for Treatment of Moderate to Severe RA
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for upadacitinib (AbbVie), an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis (RA).
News
FDA Approves New Treatment Option for Ulcerative Colitis
The expanded FDA approval was based on results from two 8-week placebo-controlled induction trials and a 52-week maintenance study.
