TY - JOUR
T1 - Tofacitinib for the treatment of ankylosing spondylitis
T2 - A phase III, randomised, double-blind, placebo-controlled study
AU - Deodhar, Atul
AU - Sliwinska-Stanczyk, Paula
AU - Xu, Huji
AU - Baraliakos, Xenofon
AU - Gensler, Lianne S.
AU - Fleishaker, Dona
AU - Wang, Lisy
AU - Wu, Joseph
AU - Menon, Sujatha
AU - Wang, Cunshan
AU - Dina, Oluwaseyi
AU - Fallon, Lara
AU - Kanik, Keith S.
AU - Van Der Heijde, Désirée
N1 - Publisher Copyright:
©
PY - 2021/8/1
Y1 - 2021/8/1
N2 - Objective To assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS). Methods This phase III, randomised, double-blind, placebo-controlled study enrolled patients aged ≥18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs, and an inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs. Patients were randomised 1:1 to receive tofacitinib 5 mg two times per day or placebo for 16 weeks. After week 16, all patients received open-label tofacitinib until week 48. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) and ≥40% improvement (ASAS40) responses, respectively, at week 16. Safety was assessed throughout. Results 269 patients were randomised and treated: tofacitinib, n=133; placebo, n=136. 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), and the ASAS40 response rate was significantly (p<0.0001) greater with tofacitinib (40.6%, 54 of 133) versus placebo (12.5%, 17 of 136). Up to week 16, with tofacitinib and placebo, respectively, 73 of 133 (54.9%) and 70 of 136 (51.5%) patients had adverse events; 2 of 133 (1.5%) and 1 of 136 (0.7%) had serious adverse events. Up to week 48, with tofacitinib, 3 of 133 (2.3%) patients had adjudicated hepatic events, 3 of 133 (2.3%) had non-serious herpes zoster, and 1 of 133 (0.8%) had a serious infection; with placebo→tofacitinib, 2 (1.5%) patients had non-serious herpes zoster. There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events or opportunistic infections. Conclusions In adults with active AS, tofacitinib demonstrated significantly greater efficacy versus placebo. No new potential safety risks were identified.
AB - Objective To assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS). Methods This phase III, randomised, double-blind, placebo-controlled study enrolled patients aged ≥18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs, and an inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs. Patients were randomised 1:1 to receive tofacitinib 5 mg two times per day or placebo for 16 weeks. After week 16, all patients received open-label tofacitinib until week 48. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) and ≥40% improvement (ASAS40) responses, respectively, at week 16. Safety was assessed throughout. Results 269 patients were randomised and treated: tofacitinib, n=133; placebo, n=136. 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), and the ASAS40 response rate was significantly (p<0.0001) greater with tofacitinib (40.6%, 54 of 133) versus placebo (12.5%, 17 of 136). Up to week 16, with tofacitinib and placebo, respectively, 73 of 133 (54.9%) and 70 of 136 (51.5%) patients had adverse events; 2 of 133 (1.5%) and 1 of 136 (0.7%) had serious adverse events. Up to week 48, with tofacitinib, 3 of 133 (2.3%) patients had adjudicated hepatic events, 3 of 133 (2.3%) had non-serious herpes zoster, and 1 of 133 (0.8%) had a serious infection; with placebo→tofacitinib, 2 (1.5%) patients had non-serious herpes zoster. There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events or opportunistic infections. Conclusions In adults with active AS, tofacitinib demonstrated significantly greater efficacy versus placebo. No new potential safety risks were identified.
KW - ankylosing
KW - antirheumatic agents
KW - spondylitis
KW - therapeutics
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UR - http://www.scopus.com/inward/citedby.url?scp=85104963716&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2020-219601
DO - 10.1136/annrheumdis-2020-219601
M3 - Article
C2 - 33906853
AN - SCOPUS:85104963716
SN - 0003-4967
VL - 80
SP - 1004
EP - 1013
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 8
ER -