A recently published report presented at the 2019 AIBD Annual Meeting in Orlando, FL, discussed the case of a patient who developed ulcerative colitis (UC) following treatment with Secukinumab for her psoriatic arthritis and highlighted a novel approach for the management of both of her conditions simultaneously.
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An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.
Researchers from the University of Calgary found moderate to high quality evidence that triple therapy with methotrexate + sulfasalazine + hydroxycholoroquine or combining methotrexate + most biologic disease-modifying antirheumatic drug (DMARDs) or tofacitinib demonstrated similar efficacy in controlling disease activity in methotrexate-naive patients or after an inadequate response to methotrexate.
The FDA has approved Xeljanz XR (tofacitinib extended-release; Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis.
Pfizer announced that the Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib citrate) extended-release tablets for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).
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.
Tocilizumab is known to raise LDL cholesterol levels but it is unclear whether the drug raises CV risk in RA patients.
The new PsA approval was based on data from the Phase 3 OPAL Broaden, OPAL Beyond, and OPAL Balance studies.
The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting. Combination biologic therapy may…
Pfizer announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Xeljanz (tofacitinib citrate) 11mg once daily modified release tablets for the treatment of moderate to severe rheumatoid arthritis in patients with inadequate response or intolerance to methotrexate.