Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis

Abstract

Introduction The safety of tofacitinib in psoriatic arthritis (PsA) and rheumatoid arthritis (RA) has been demonstrated in clinical studies of ≤ 4 and 9.5 years, respectively. Post-marketing surveillance (PMS) data for tofacitinib from spontaneous and voluntary adverse event (AE) reports have been published for RA, but not PsA. To inform the real-world safety profile of tofacitinib in PsA, we evaluated AE reports submitted to the Pfizer safety database (including RA data for context). Methods Endpoints included AEs, serious AEs (SAEs), AEs of special interest (AESIs; serious infections, herpes zoster, cardiovascular events, malignancies, venous thromboembolism), and fatal cases. Exposure was estimated using IQVIA global commercial sales data. Number, frequency, and reporting rates (RRs; number of events/100 patient-years’ [PY] exposure) were summarized by indication and formulation (immediate release [IR] 5 or 10 mg twice daily], modified release [MR] 11 mg once daily, or all tofacitinib). The data-collection period differed by indication (PsA: 14 December 2017 [US approval, IR/MR] to 6 November 2021; RA: 6 November 2012 [US approval, IR] to 6 November 2021; MR approval, 24 February 2016). Results A total of 73,525 case reports were reviewed (PsA = 5394/RA = 68,131), with 20,706/439,370 PY (PsA/RA) of exposure. More AEs were reported for IR versus MR (IR/MR: PsA = 8349/7602; RA = 137,476/82,153). RRs for AEs (IR/MR: PsA = 59.6/113.4; RA = 44.0/64.8) and SAEs (PsA = 8.1/13.6; RA = 8.0/9.5) were higher with MR versus IR. AE RRs (RA) in the first 4 years after IR approval were 95.9 (IR; 49,439 PY) and 147.0 (MR; 2000 PY). Frequency of SAEs, AESIs, and fatal cases was mostly similar across formulations and indications. The most frequently-reported AE Preferred Terms (PsA/RA) included drug ineffective (20.0%/17.8%), pain (9.7%/10.6%), condition aggravated (9.9%/10.5%), headache (8.8%/7.9%) and, for PsA, off-label use (10.5%/3.4%). Conclusions Tofacitinib PMS safety data from submitted AE reports were consistent between PsA and RA, and aligned with its known safety profile. Exposure data (lower MR versus IR; estimation from commercial sales data), reporting bias, reporter identity, and regional differences in formulation use limit interpretation. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-023-00576-8.

The temporal association between adverse drug reactions and antirheumatic drugs utilisation in Western Australia: a retrospective study from real-world data (1995–2015)

“…This highlights the importance of healthcare professionals being aware of and actively managing the ADRs of DMARDs. This includes comprehensive assessment [ 36 ], safe prescribing [ 37 ], risk communications [ 36 ], monitoring [ 35 ], education [ 36 ], post-marketing surveillance [ 38 ], and reporting ADRs to the relevant authorities.…”

Efficacy of tofacitinib in psoriatic arthritis: literature review and case report

“…Чтобы получить информацию о реальном профиле безопасности ТОФА при ПсА, были оценены отчеты о НЯ, представленные в базу данных безопасности компании-производителя (конечными точками были НЯ, серьезные НЯ, НЯ, представляющие особый интерес (серьезные инфекции, опоясываю щий герпес, сердечно-сосудистые события, злокачественные новообразования, венозная тромбоэмболия) и фатальные случаи. Полученные результаты анализа рисков при применении ТОФА из представленных отчетов о НЯ не раз личались по частоте среди больных ПсА и РА и соответствовали уже известному при лечении РА профилю безопасности [44]. L.E.…”