Tofacitinib Has Positive Results in Phase 3 for Psoriatic Arthritis
The OPAL (Oral Psoriatic Arthritis triaL) Broaden study is a Phase 3 clinical trial evaluating tofacitinib for treating psoriatic arthritis.1 This study evaluated the safety and efficacy of 5 mg tofacitinib and 10 mg tofacitinib twice daily in adults with active psoriatic arthritis who had an inadequate response to at least one conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) and who had not yet tried a tumor necrosis factor inhibitor (TNFi-naive).
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At Month 3, primary efficacy endpoint measures were demonstrated for both active dosing regimens and were superior to placebo. These endpoints included the ACR20 response and the Health Assessment Questionnaire Disability Index (HAQ-DI) score. The study evaluated improvement in physical functioning. During the study, patients were allowed to continue background csDMARDs at a stable dose. An active control arm in the study was 40 mg adalimumab administered subcutaneously every two weeks. Overall, 422 patients were randomized in a 2:2:2:1:1 ratio to one of the following treatment arms: 5 mg tofacitinib twice daily, 10 mg tofacitinib twice daily, 40 mg adalimumab every two weeks, placebo to 5 mg tofacitinib twice daily, and placebo to 10 mg tofacitinib twice daily.
During this 12-month study, safety results were consistent with those previously described. All treatment groups had similar rates of treatment emergent adverse events, serious adverse events and adverse events leading to therapy discontinuation. Observed serious adverse events were consistent with events seen in other tofacitinib clinical trials.
FDA Updates Warning for Saxagliptin & Alogliptin Diabetes Medications
Following a safety review, the U.S. Food and Drug Administration (FDA) has updated the Feb. 11, 2014, Drug Safety Communication related to an increased risk of heart failure, particularly in patients who already have heart or kidney disease, in individuals taking saxagliptin and alogliptin.2 New warnings are, therefore, being added to the drugs’ labels.
The FDA evaluated two large clinical trials conducted in patients with heart disease that showed that more patients who received medicines containing saxagliptin or alogliptin were hospitalized for heart failure compared with patients who received placebo. Saxagliptin-treated patients had a 3.5% heart failure hospitalization rate compared with 2.8% of placebo-treated patients. This finding equates to 35 of every 1,000 patients vs. 28 of every 1,000 patients. Alogliptin-treated patients had a 3.9% heart failure hospitalization rate compared with 3.3% of placebo-treated patients, which equates to 39 of every 1,000 patients vs. 33 of every 1,000 patients.
Healthcare professionals who identify patients who develop heart failure symptoms while taking alogliptin or saxagliptin should consider discontinuing these medications and seek other medications for glucose control.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to medication use to FDA’s MedWatch Adverse Event Reporting Program.
Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Pfizer Inc. News release: Pfizer announces positive top-line results from the first phase 3 trial of investigational tofacitinib in adults with psoriatic arthritis. 2016 Apr 5.
- U.S. Food and Drug Administration. Safety alert: Diabetes medications containing aaxagliptin and slogliptin: drug safety communication—risk of heart failure. 2016 Apr 5.