Emery, P orcid.org/0000-0002-7429-8482, van Hoogstraten, H, Thangavelu, K et al. (3 more authors) (2020) Subcutaneous Sarilumab in Patients with Rheumatoid Arthritis who Previously Received Subcutaneous Sarilumab or Intravenous Tocilizumab: An Open-Label Extension of a Randomized Clinical Trial. ACR Open Rheumatology, 2 (11). pp. 672-680. ISSN 2578-5745
Abstract
Objective
This post hoc analysis evaluated the safety and efficacy of open‐label sarilumab in patients with rheumatoid arthritis (RA) who completed the phase III double‐blind ASCERTAIN study (NCT01768572) and switched from intravenous (IV) tocilizumab to subcutaneous (SC) sarilumab, or who continued SC sarilumab in the open‐label extension (OLE) study EXTEND (NCT01146652).
Methods
Patients who completed ASCERTAIN were eligible to enroll in EXTEND to receive sarilumab 200 mg SC every 2 weeks (Q2W). Safety and efficacy were reported through 96 weeks in the OLE in patients who switched from tocilizumab IV to sarilumab 200 mg SC Q2W, who switched from sarilumab 150 mg SC Q2W to sarilumab 200 mg SC Q2W, or who continued sarilumab 200 mg SC Q2W.
Results
Of 175 patients who completed ASCERTAIN, 168 (96%) enrolled in EXTEND, and 38 of these patients (23%) discontinued the OLE. Cumulative sarilumab exposure during follow‐up was 273.7 patient‐years. No new safety signals were identified, infections occurred at a rate of 59.9/100 patient‐years, and there were no cases of grade 4 neutropenia. Efficacy—as assessed by Disease Activity Score (28 joints) based on C‐reactive protein, Clinical Disease Activity Index, and Health Assessment Questionnaire‐Disability Index scores—was sustained over 96 weeks of follow‐up when switching to, or continuing, sarilumab 200 mg SC Q2W.
Conclusion
Switching from IV to SC interleukin‐6 receptor inhibitor therapy produced no new safety concerns, and clinical efficacy was sustained over 96 weeks of follow‐up. These findings alleviate potential concerns over switching route of administration with interleukin‐6 receptor inhibitor therapy for RA.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2020 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Institute of Rheumatology & Musculoskeletal Medicine (LIRMM) (Leeds) > Inflammatory Arthritis (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 28 Aug 2020 13:29 |
Last Modified: | 23 Mar 2021 10:14 |
Status: | Published |
Publisher: | Wiley |
Identification Number: | 10.1002/acr2.11188 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:164879 |