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  • Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study

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Rheumatoid arthritis
Original research
Long-term safety and efficacy of upadacitinib versus adalimumab in patients with rheumatoid arthritis: 5-year data from the phase 3, randomised SELECT-COMPARE study
  1. Roy Fleischmann1,
  2. Jerzy Swierkot2,
  3. Sara K Penn3,
  4. Patrick Durez4,
  5. Louis Bessette5,
  6. Xianwei Bu3,
  7. Nasser Khan3,
  8. Yihan Li3,
  9. Charles G Peterfy6,
  10. Yoshiya Tanaka7 and
  11. Eduardo Mysler8
  1. 1Metroplex Clinical Research Center, University of Texas Southwestern Med Center, Dallas, Texas, USA
  2. 2Department of Rheumatology and Internal Medicine, Wroclaw Medical University, Wroclaw, Poland
  3. 3Immunology, AbbVie, North Chicago, Illinois, USA
  4. 4Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, UCLouvain Saint-Luc, Brussels, Belgium
  5. 5Rheumatology, Laval University, Quebec, Quebec, Canada
  6. 6Spire Sciences Inc, Boca Raton, Florida, USA
  7. 7The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan
  8. 8Rheumatology, Organización Medica de Investigación, Buenos Aires, Argentina
  1. Correspondence to Dr Roy Fleischmann; rfleischmann{at}arthdocs.com

Abstract

Objectives To assess the safety and efficacy of upadacitinib versus adalimumab from SELECT-COMPARE over 5 years.

Methods Patients with rheumatoid arthritis and inadequate response to methotrexate were randomised to receive upadacitinib 15 mg once daily, placebo or adalimumab 40 mg every other week, all with concomitant methotrexate. By week 26, patients with insufficient response to randomised treatment were rescued; patients remaining on placebo switched to upadacitinib. Patients completing the 48-week double-blind period could enter a long-term extension. Safety and efficacy were assessed through week 264, with radiographic progression analysed through week 192. Safety was assessed by treatment-emergent adverse events (TEAEs). Efficacy was analysed by randomised group (non-responder imputation (NRI)) or treatment sequence (as observed).

Results Rates of TEAEs were generally similar with upadacitinib versus adalimumab, although numerically higher rates of herpes zoster, lymphopenia, creatine phosphokinase elevation, hepatic disorder and non-melanoma skin cancer were reported with upadacitinib. Numerically greater proportions of patients randomised to upadacitinib versus adalimumab achieved clinical responses (NRI); Clinical Disease Activity Index remission (≤2.8) and Disease Activity Score based on C reactive protein <2.6 were achieved by 24.6% vs 18.7% (nominal p=0.042) and 31.8% vs 23.2% (nominal p=0.006), respectively. Radiographic progression was numerically lower with continuous upadacitinib versus adalimumab at week 192.

Conclusion The safety profile of upadacitinib through 5 years was consistent with the known safety profile of upadacitinib, with no new safety risks. Clinical responses were numerically higher with upadacitinib versus adalimumab at 5 years. Upadacitinib demonstrates a favourable benefit–risk profile for long-term rheumatoid arthritis treatment.

Trial registration number NCT02629159.

  • Antirheumatic Agents
  • Arthritis, Rheumatoid
  • Biological Therapy
  • Inflammation

Data availability statement

Data are available on reasonable request. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymised, individual-level and trial-level data (analysis datasets), as well as other information (eg, protocols and clinical study reports), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan, and execution of a Data Sharing Agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/rmdopen-2023-004007

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    Data availability statement

    Data are available on reasonable request. AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymised, individual-level and trial-level data (analysis datasets), as well as other information (eg, protocols and clinical study reports), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan, and execution of a Data Sharing Agreement. Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.

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    Footnotes

    • Contributors RF, YL and CGP contributed to the study conception and design. RF, JS, PD, LB, CGP, YT and EM participated in data acquisition. SKP and NK were involved in the interpretation of the data. XB and YL conducted the statistical analyses. All authors analysed and interpreted the data and contributed to the critical revision of the manuscript. All named authors met the International Committee of Medical Journal Editors criteria for authorship for this article, take responsibility for the integrity of the work as a whole and have given their approval for this version to be published. RF acts as guarantor and accepts full responsibilty for the work, had access to the data, and controlled the decision to publish.

    • Funding This work is supported by AbbVie, who is funding this trial and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review and approval of this publication. No honoraria or payments were made for authorship.

    • Competing interests RF has received consulting fees and/or grant/research support from AbbVie, Amgen, BI, Biosplice, BMS, Flexion, Galapagos, Galvani, Gilead, GSK, Horizon, Janssen, Lilly, Novartis, Pfizer, Sanofi-Aventis, Selecta, UCB, Viela, Vorso and Vyne and has participated on a data safety monitoring board or advisory board for Kiniksa. JS has received speaking fees, consulting fees and grant/research support from AbbVie, Accord, BMS, Janssen, MSD, Pfizer, Roche, Sandoz and UCB. SKP, XB, NK and YL are employees of AbbVie and may hold stock or options. PD has received speaker fees from AbbVie, Galapagos, Lilly, Nordimed and Thermofischer. LB has received speaking fees, consulting fees and grant/research support from AbbVie, Amgen, BMS, Celgene, Lilly, Fresenius Kabi, Gilead, Janssen, Novartis, Organon, Pfizer, Sanofi-Aventis, Teva and UCB. CGP is an employee and shareholder of Spire Sciences and has served as a consultant for Aclaris, AstraZeneca, Daiichi-Sankyo, Five Prime, Genentech, Gilead, GSK, Istesso, Labcorp, Lilly, Pacira, Paradigm, SetPoint, Sorrento, SynOx and UCB. YT has received speaker fees and/or honoraria from AbbVie, Asahikasei, AstraZeneca, BI, BMS, Chugai, Eisai, Gilead, GSK, Lilly, Pfizer, Taiho and Taisho and research grants from Asahikasei, Chugai, Eisai, Mitsubishi-Tanabe and Taisho. EM has received speaking fees, consulting fees and grant/research support from AbbVie, Amgen, AstraZeneca, BMS, Hi-Bio, Janssen, Lilly, Novartis, Pfizer, Roche, Sandoz and Sanofi, and has received payment for expert testimony from AbbVie.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.