Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis
Rheumatol Ther. 2023 doi: 10.1007/s40744-023-00576-8 Epub ahead of print
The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.
Safety Profile of Upadacitinib over 15 000 Patient-years Across Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis
RMD Open. 2023;9(1):e002735 doi: 10.1136/rmdopen-2022-002735
Integrated analysis of the safety profile of upadacitinib demonstrates that it was generally well-tolerated in RA, PsA, AS and AD, with no new safety risks identified, compared with previous reports.
Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
Rheumatol Ther. 2022. Epub ahead of print doi: 10.1007/s40744-022-00507-z
This post-hoc analysis of 31 clinical trials in ulcerative colitis, rheumatoid arthritis and psoriatic arthritis concludes that combined influenza adverse event incidence rates were highest in ulcerative colitis, while in each indication they were generally similar across tofacitinib, placebo, and comparator groups.
Nat Rev Rheumatol. 2022. Epub ahead of print doi: 10.1038/s41584-022-00767-7Putting the data into context, Winthrop, et al. conclude that the ORAL Surveillance data are not dissimilar to those from the original developmental programme, which suggested additional safety concerns at the 10 mg dosage and that resulted in the 5 mg twice daily dosage as the approved dose for RA.Following the recent results of the ORAL Surveillance (ORALSURV) study, and the consequent changes to the utilisation of JAKinibs, made by the regulatory authorities, Winthrop, et al. aim to put the O...
Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel)
Clin Rheumatol. 2022 Jan 1. Epub ahead of print doi: 10.1007/s10067-021-05908-zPost-hoc analysis shows that dosing up from tofacitinib 5 to 10 mg BID is associated with improved efficacy for up to 12 months, versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID is not generally associated with a significant loss of efficacy.Although clinical trials have generally shown no significant differences, in terms of efficacy and safety, when switching tofacitinib dose up or down, these per-protocol switches are not directly informative for clinical decision-making in dai...
Safety Profile of Upadacitinib in Rheumatoid Arthritis: Integrated Analysis from the SELECT Phase III Clinical Programme
Ann Rheum Dis 2020 DOI:10.1136/annrheumdis-2020-218510This integrated Phase III safety analysis of UPA showed that UPA had a similar profile to ADA and MTX for serious infections, malignancies, and thromboembolic events. Patients receiving UPA had increased risk of HZ and creatine phosphokinase elevation versus ADA.This integrated Phase III safety analysis of UPA examined >3500 RA patients and 4000 patient-years of exposure. Data were pooled from 3834 patients in SELECT-NEXT, SELECT-BEYOND, SELECT-MONOTHERAPY, SELECT-COMPARE and SELECT-EARLY studie...