The aim of a study was to describe the long-term safety and efficacy profile of Tofacitinib ( Xeljanz ) in patients with moderate to severe active rheumatoid arthritis.
Data were pooled from 2 open-label studies ( NCT00413699, NCT00661661 ) involving patients who had participated in qualifying phase I, II, or III index studies of Tofacitinib.
Safety data included over 60 months of observation; efficacy data are reported up to Month 48. Treatment was initiated with Tofacitinib 5 or 10 mg twice daily.
Primary endpoints were adverse events and laboratory safety data. Secondary endpoints included American College of Rheumatology ( ACR ) response rates, and Disease Activity Score ( 28 joints ) ( DAS28 )-4[ erythrocyte sedimentation rate ( ESR ) ] and Health Assessment Questionnaire-Disability Index ( HAQ-DI ) assessments.
Overall, 4102 patients were treated for 5963 patient-years; mean ( maximum ) treatment duration was 531 ( 1844 ) days; 20.8% of patients discontinued treatment over 60 months.
The most common adverse effects were nasopharyngitis ( 12.7% ) and upper respiratory tract infection ( 10.5% ). Serious adverse reactions were reported in 15.4% of patients with an exposure-estimated incidence rate of 11.1 events/100 patient-years.
Serious infections were reported in 4.5% of patients with an exposure-estimated incidence rate of 3.1 events/100 patient-years ( 95% CI: 2.66-3.55 ).
Mean values for laboratory variables were stable over time and consistent with phase II and III studies.
Persistent efficacy was demonstrated through Month 48, as measured by ACR response rate ( ACR20/50/70 ) DAS28-4-ESR, and HAQ-DI.
Safety and efficacy were similar for patients receiving Tofacitinib as monotherapy or with background nonbiologic disease-modifying antirheumatic drugs.
In conclusion, Tofacitinib has demonstrated consistent safety and persistent efficacy over 48 months in patients with rheumatoid arthritis. ( Xagena )
Wollenhaupt J et al, J Rheumatol 2014; Epub ahead of print