Abstract
Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs. Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Worldwide tofacitinib PMS data received in the Pfizer safety database from November 6, 2012 (first marketing authorization of tofacitinib) to November 5, 2015 were analyzed. Serious AEs (SAEs) of interest were reviewed and reporting rates (RRs) were calculated by dividing the number of SAEs by the estimated 100 patient-years of exposure. Patient exposure was calculated based on estimated worldwide sales and an estimated daily regimen of tofacitinib 5mg twice daily. During the 3-year reporting period, worldwide post-marketing exposure to tofacitinib since approval was estimated to be 34,223 patient-years. In total, 9291 case reports (82.9% non-serious) were received and 25,417 AEs, 102 fatal cases, and 4352 SAEs were reported. The RRs (per 100 patient-years) for SAEs of interest by Medical Dictionary for Regulatory Activities System Organ Class were 2.57 for infections, 0.91 for gastrointestinal disorders, 0.60 for respiratory disorders, 0.45 for neoplasms, 0.43 for cardiac disorders, and 0.12 for hepatobiliary disorders. Although there are limitations to these data, no new safety risks were revealed in this real-world setting compared with the safety profile identified in the tofacitinib RA clinical development program. Any risks identified through the tofacitinib development program and PMS will continue to be monitored through pharmacovigilance surveillance. Pfizer Inc.
Highlights
Post-marketing surveillance (PMS) is an integral part of monitoring adverse events (AEs) following approval of new drugs.Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)
We aimed to evaluate the safety of tofacitinib in the post-marketing setting using spontaneous/non-interventional solicited PMS reports and non-study literature cases during the 3 years following first marketing authorization
The most recorded SAEs by System Organ Class (SOC) related to loss of efficacy of tofacitinib, followed by serious infections; the reporting rates (RRs) of these events decreased over time
Summary
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). An analysis of PMS reports was conducted to evaluate the safety of tofacitinib in a post-marketing setting. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. Tofacitinib received first marketing authorization in the United States (US) on November 6, 2012 for the treatment of adults with moderately to severely active RA and an inadequate response/intolerance to methotrexate. As of November 2015 (data-cut for analysis), tofacitinib was approved in 46 countries and marketed in 29 countries. Tofacitinib has since received marketing authorization in the European Union and is currently approved in over 80 countries worldwide. The approved tofacitinib dose for RA is 5 mg twice daily (BID); a 10 mg BID dose is approved in Botswana, Switzerland, and Russia. An extended-release formulation, dosed at 11 mg once daily, has been approved in the US for the same indication
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