Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study
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  • Published on:
    Rapid response to: Correspondence to: “Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study” by “Deodhar et al.” by James Cheng-Chung Wei et al.
    • Atul Deodhar, Rheumatologist Oregon Health & Science University
    • Other Contributors:
      • Huji Xu, Rheumatologist
      • Xenofon Baraliakos, Rheumatologist
      • Lianne S Gensler, Rheumatologist
      • Dona Fleishaker, Pfizer employee
      • Lisy Wang, Pfizer employee
      • Joseph Wu, Pfizer employee
      • Sujatha Menon, Pfizer employee
      • Cunshan Wang, Pfizer employee
      • Oluwaseyi Dina, Pfizer employee
      • Lara Fallon, Pfizer employee
      • Keith S Kanik, Pfizer employee
      • Désirée van der Heijde, Rheumatologist

    We welcome the correspondence to our article, which reported results of a phase III study (NCT03502616), by James Cheng-Chung Wei and colleagues.1

    Considering the primary endpoint, Assessment of SpondyloArthritis International Society (ASAS) 20 response rates at week 16, significant improvements vs placebo were evident with tofacitinib 5 mg two times per day (BID). The response rate with tofacitinib 5 mg BID did decline very slightly from week 12 to week 16, before continuing to improve through week 48 (figure 2A). A similar pattern was observed in some secondary endpoints (ASAS40 response rates [figure 2B]; change from baseline in Ankylosing Spondylitis Disease Activity Score [ΔASDAS; figure 3A] and high-sensitivity C-reactive protein [ΔhsCRP; figure 3B]; ASAS 5/6 response [supplemental figure 3B]; ASDAS low disease activity [ASDAS LDA; supplemental figure 4C]; and ASDAS inactive disease [supplemental figure 4D]), although for all other endpoints, improvements were steady or increased through week 16.

    We believe that what may be perceived as a ‘dip’ in efficacy at week 16 was likely due to patient variability. Notably, this ‘dip’ was most pronounced for ASAS20 response rates, an endpoint which is often associated with variability, compared with the more conservative endpoints (ASAS40 response rates, ASAS5/6 and ASDAS LDA), for which the differences between week 12 and week 16 were numerically smaller than for ASAS20 response rates. Additionally, for hsCRP,...

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    Conflict of Interest:
    AD has received grant/research support from AbbVie, Boehringer Ingelheim, Eli Lilly, GSK, Novartis, Pfizer Inc and UCB, and is a consultant for AbbVie, Amgen, Boehringer Ingelheim, BMS, Celgene, Eli Lilly, Galapagos, Gilead Sciences, GSK, Janssen, Novartis, Pfizer Inc and UCB. HX has no competing interests to declare. XB is a consultant for AbbVie, Amgen, BMS, Celgene, Eli Lilly, Gilead Sciences, Janssen, MSD, Novartis, Pfizer Inc and UCB. LSG has received grant/research support from Pfizer Inc and UCB, and is a consultant for AbbVie, Eli Lilly, Gilead Sciences, GSK, Novartis and UCB. DF, LW, JW, SM, CW, OD, LF and KSK are employees and shareholders of Pfizer Inc. DvdH is a consultant for AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eli Lilly, Galapagos, Gilead Sciences, GSK, Janssen, Merck, Novartis, Pfizer Inc, Regeneron, Roche, Sanofi, Takeda and UCB, and is Director of Imaging Rheumatology BV.
  • Published on:
    Correspondence to “Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study” by “Deodhar et al.”
    • James Cheng-Chung Wei, rheumatologist Department of Allergy, Immunology & Rheumatology, Chung Shan Medical University Hospital
    • Other Contributors:
      • Amy Ker, student
      • Cheng-Ruei Yang, student
      • Tzu-Hsuan Hsiao, student

    We read with great interest the article of Deodhar et al assessing the efficacy of tofacitinib in adult patients with active ankylosing spondylitis.[1] The study is interesting and the results are provocative, yet some concerns still remain to be discussed.

    Firstly, we have noticed an unexplained pattern in the results of the primary and a few secondary endpoints of the tofacitinib group. In Figure 2A, the ASAS20 response rate increases in the first few weeks but declines at week 16, and then it continues to rise steadily. Also, in Figure 2B, Figure 3, and online supplemental figures, similar counter-trends at week 16 can be found in ASAS40 response rate, ΔASDAS, ΔhsCRP, ASAS 5/6 response, ASDAS LDA, and ASDAS inactive disease. We would like to know the reasons why the results are presented in the current way instead of showing a steady upward trend, and we hope to receive a more detailed explanation of your data.

    Secondly, the drugs combination and drug-drug interaction should be brought into discussion. The enrolled patients in this study were receiving continuous background therapies such as NSAID, methotrexate (MTX), sulfasalazine, and oral corticosteroids respectively. Yet, a previous study has shown that rheumatoid arthritis patients treated with tofacitinib with a combination of MTX achieved better improvements in the clinical outcomes.[2] Therefore, the subgroup analyses are strongly suggested to analyze the combined medication effects to ensure the a...

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    Conflict of Interest:
    None declared.