Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

Summary

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

Timeline

Start

2018-06-07

Primary completion

2019-12-19

Completion

2020-08-20

Outcome

Met primary endpoint

paper At week 16, the ASAS20 response rate was significantly (p<0.0001) greater with tofacitinib (56.4%, 75 of 133) versus placebo (29.4%, 40 of 136) PMID 33906853 ↗

Publications

• Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2.
• Deodhar A, Akar S, Curtis JR, El-Zorkany B, Magrey M, Wang C, Wu J, Makgoeng SB, Vranic I, Menon S, Fleishaker DL, Diehl AM, Fallon L, Yndestad A, Landewe RBM. Integrated safety analysis of tofacitinib from Phase 2 and 3 trials of patients with ankylosing spondylitis. Adv Rheumatol. 2024 Dec 18;64(1):87. doi: 10.1186/s42358-024-00402-x.
• Gossec L, Walsh JA, Sengupta R, Bushmakin AG, Cappelleri JC, Yndestad A, Dina O, Cella D. Improvement of Fatigue in Patients with Ankylosing Spondylitis Receiving Tofacitinib: Analyses of a Phase 3 Randomized Controlled Trial. Rheumatol Ther. 2025 Feb;12(1):85-98. doi: 10.1007/s40744-024-00727-5. Epub 2024 Dec 13.
• Norton H, Sliwinska-Stanczyk P, Hala T, El-Zorkany B, Stockert L, Mundayat R, Wang L, Ritchlin CT. Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials. Rheumatol Ther. 2025 Feb;12(1):67-84. doi: 10.1007/s40744-024-00726-6. Epub 2024 Dec 5.
• Ogdie A, Kristensen LE, Soriano ER, Akar S, Sun Y, Gruben D, Fallon L, Kinch CD, Gladman DD. Efficacy and Safety of Tofacitinib in Patients with Psoriatic Arthritis or Ankylosing Spondylitis by Cigarette Smoking Status. Rheumatol Ther. 2024 Dec;11(6):1649-1664. doi: 10.1007/s40744-024-00711-z. Epub 2024 Sep 25.
• Deodhar A, Baraliakos X, Magrey M, Gensler LS, Thorat AV, Pemmaraju SK, Cadatal MJ, Nash P. Efficacy and Safety of Tofacitinib in Ankylosing Spondylitis by Baseline C-Reactive Protein Level: Post Hoc Analysis of Phase II and Phase III Clinical Trials. J Rheumatol. 2024 Aug 1;51(8):772-780. doi: 10.3899/jrheum.2023-1198.
• Navarro-Compan V, Deodhar A, Bahiri R, Bushmakin AG, Cappelleri JC, Rammaoui J. Time to improvement of pain, morning stiffness, fatigue, and disease activity in patients with ankylosing spondylitis treated with tofacitinib: a post hoc analysis. Arthritis Res Ther. 2024 May 24;26(1):105. doi: 10.1186/s13075-024-03313-w.
• Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2.
• Magrey M, Wei JC, Yndestad A, Bushmakin AG, Cappelleri JC, Dina O, Deodhar A. Relationships of Work Productivity and Activity Impairment With Patient-Reported Outcomes in Ankylosing Spondylitis: Results From Two Trials. Arthritis Care Res (Hoboken). 2024 Mar;76(3):359-365. doi: 10.1002/acr.25267. Epub 2024 Jan 5.
• Cella D, Lenderking WR, Chongpinitchai P, Bushmakin AG, Dina O, Wang L, Cappelleri JC, Navarro-Compan V. Functional Assessment of Chronic Illness Therapy-Fatigue is a reliable and valid measure in patients with active ankylosing spondylitis. J Patient Rep Outcomes. 2022 Sep 23;6(1):100. doi: 10.1186/s41687-022-00508-0.
• Navarro-Compan V, Wei JC, Van den Bosch F, Magrey M, Wang L, Fleishaker D, Cappelleri JC, Wang C, Wu J, Dina O, Fallon L, Strand V. 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 Jun;8(2):e002253. doi: 10.1136/rmdopen-2022-002253.
• Deodhar A, Sliwinska-Stanczyk P, Xu H, Baraliakos X, Gensler LS, Fleishaker D, Wang L, Wu J, Menon S, Wang C, Dina O, Fallon L, Kanik KS, van der Heijde D. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021 Aug;80(8):1004-1013. doi: 10.1136/annrheumdis-2020-219601. Epub 2021 Apr 27.

Drugs

Indications