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Risk characterization approach enables safety comparisons between Xeljanz, TNF inhibitors
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Use of a risk characterization approach served as an indirect way to contextualize the safety profile of Xeljanz, a Janus kinase inhibitor, in patients with rheumatoid arthritis vs. the safety profile of tumor necrosis factor-alpha inhibitors, according to research presented at the European League Against Rheumatism Annual European Congress of Rheumatology.
Based on Poisson distribution, Jeffrey R. Curtis, MD, MS, MPH, of the University of Alabama at Birmingham, Division of Clinical Immunology and Rheumatology, and colleagues conducted power calculations to estimate minimum number of patient years (PY) of exposure needed to produce a probability of 90% for the lower boundary confidence interval greater than 1 for Xeljanz (tofacitinib citrate, Pfizer) minus tumor necrosis factor-alpha (TNF-a) inhibitor, for a rate of tofacitinib exposure of 1.2-, 1.5- or 2-times the comparator rates.
Jeffrey R. Curtis
TNF-a inhibitor rates of exposure and adverse events were acquired from published clinical trials, observational studies and other sources to create similarity with the tofacitinib clinical trial database for baseline patient characteristics, duration of study and average length of patient follow-up.
According to study projections, approximately 18,000 PY of exposure to tofactinib will be accumulated within the rheumatoid arthritis (RA) clinical development program, in which patients receive two doses of tofacitinib daily. Most of the data will come from patients who were treated for at least 3 years, according to the researchers.
“For new therapies, it is important to contextualize safety with established therapies such as TNF inhibitors,” the researchers wrote. “Ongoing and planned prospective active surveillance complement the data generated from clinical trials.” – by Monica Jaramillo
Reference:
Curtis JR, et al. Paper #SAT0346. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.
Disclosures: Curtis reports grant and research support from Pfizer. Please see the full study for a list of all other authors’ relevant financial disclosures.