Tofacitinib Efficacy and Safety in Patients With Ankylosing Spondylitis by Prior Biologic Disease-Modifying Antirheumatic Drug Use: A Post Hoc Analysis
ACR Open Rheumatol. 2023 Sep 29 doi 10.1002/acr2.11601 Epub ahead of print
In this post hoc analysis by Deoodhar, et al., the authors found that tofacitinib demonstrated greater efficacy than placebo in bDMARD-naïve and TNFi-IR AS patients. They also found that safety event rates for tofacitinib therapy were numerically higher in the TNFi-IR subgroup than the bDMARD-naïve subgroup.
Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial
Rheumatol Ther. 2023 doi 10.1007/s40744-023-00564-y Epub ahead of print
Tofacitinib treatment is associated with a significant improvement in CANDEN MRI scores of spinal inflammation in axSpA patients. This study by Østergaard, et al. also validates the CANDEN MRI scoring system as an approach for measuring axSpA-associated inflammatory lesions.
Malignancy Risk with Tofacitinib versus TNF Inhibitors in Rheumatoid Arthritis: Results from the Open-Label, Randomised Controlled Oral Surveillance Trial
Ann Rheum Dis. 2023;82(3):331–343 doi: 10.1136/ard-2022-222543
Results from the open-label, randomised controlled ORAL Surveillance trial find increased risk of malignancies with tofacitinib versus TNFi, highlighting the highest incidence in patients with a history of atherosclerotic cardiovascular disease or increasing cardiovascular risk.
Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme
Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-223406 Epub ahead of print
Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).
Risk of MACE with Tofacitinib Versus TNFi in Patients with RA With or Without a History of Atherosclerotic CV: A Post Hoc Analysis from ORAL Surveillance
Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222259
Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).
Effect of Tofacitinib on Pain, Fatigue, Health-related Quality of Life and Work Productivity in Patients with Active Ankylosing Spondylitis: Results from A Phase III, Randomised, Double-blind, Placebo-controlled Trial
RMD Open 2022 doi:10.1136/rmdopen-2022-002253
Navarro-Compán et al, determined the effectiveness of tofacitinib in patients with active ankylosing spondylitis in a Phase III, randomised, double-blind, placebo-controlled trial.
Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study
Ann Rheum Dis. 2021 Apr 27;80(8):1004–13.A Phase 3 study assesses the efficacy and safety of tofacitinib in adults with active AS.Deodhar, et al. found that ASAS20 and ASAS40 response rate significantly increased with tofacitinib 5 mg BID versus placebo at Week 16, with improvements maintained to Week 48.There were no new safety signals detected over the course of the study....
Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized Phase 3 studies
J Eur Acad Dermatol Venereol 2020;34:2809–2820.Considering the multi-domain nature of PsA, effective treatments must demonstrate efficacy across a range of clinical and patient-reported outcomes. Dermatologic symptoms often precede rheumatic manifestations in people with PsA, typically by 10 years. Tofacitinib demonstrated significant improvements across a range of outcomes including burdensome dermatologic symptoms. This post hoc analysis included data from two double-blind, Phase 3 studies in patients with active PsA and an inadequate resp...
Safety and Efficacy of Tofacitinib in Patients with Active Psoriatic Arthritis: Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study
Rheumatol Ther 2020 doi.org/10.1007/s40744-020-00209-4This 3-year, open-label, LTE study follows PsA patients previously treated in pivotal studies OPAL Broaden and OPAL Beyond. It demonstrates maintained safety and efficacy of tofacitinib up to 36 and 30 months, respectively. No new safety concerns are highlighted. Previous P3 studies, OPAL Broaden and OPAL Beyond, demonstrated safety and efficacy of 5mg and 10mg tofacitinib BID in PsA. These patients rolled over to OPAL Balance for a period of 36 months. 686 participants were used in this interim...