Article
Switching from reference etanercept to Sandoz etanercept in patients with rheumatoid arthritis in Germany: An interim analysis of real-world data from the COMPACT study
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Authors
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Marc Schmalzing
- Rheumatology/Clinical Immunology, Department of Internal Medicine II, University Hospital, Würzburg
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Silke Zinke
- Rheumapraxis Berlin-Lichtenberg, Berlin
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Maren Sieburg
- Allied Rheumatology Practice, Magdeburg
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Thomas Alexander Kupka
- Rheumazentrum Kupka, Altenburg
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Charlotte Both
- Sandoz Hexal AG, Holzkirchen
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Fabricio Furlan
- Sandoz Hexal AG, Holzkirchen
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Sohaib Hachaichi
- Sandoz Hexal AG, Holzkirchen
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Herbert Kellner
- Center for Rheumatology and Gastroenterology, Hospital Neuwittelsbach, Munich
| Published: | September 14, 2021 |
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Outline
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Introduction: COMPACT is an ongoing, prospective, non-interventional study to evaluate drug persistence, effectiveness, safety, and quality of life with Sandoz etanercept (SDZ ETN) treatment in patients with rheumatoid arthritis (RA), axial spondyloarthritis or psoriatic arthritis under real-world conditions. An interim analysis of the effectiveness and safety data is reported, focusing on patients with RA who were in clinical remission or low disease activity (LDA) under treatment with reference ETN or biosimilar ETN (other than SDZ ETN [iETN]) and switched to SDZ ETN.
Methods: Patients were categorized under four treatment groups based on prior treatment status: Group A, patients in clinical remission or LDA under treatment with iETN and switched to SDZ ETN; Group B, patients who received targeted therapies and switched to SDZ ETN; Group C, biologic-naïve considered uncontrolled with conventional therapy; Group D, DMARD-naïve with recent diagnosis of RA considered suitable for treatment initiation with a biologic and started on treatment with SDZ ETN. Effectiveness assessment included Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) until Week 24 after enrolment (baseline). Functional disability was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Effectiveness and safety results are reported for the German RA patients who switched from iETN (Group A).
Results: Of the 1437 patients recruited, 457 were from Germany. Of the 285 patients with RA, 65 were switched from iETN (Group A). Comorbidities were frequent in patients with RA (82.1%); musculoskeletal and connective tissue disorders were reported in 39.3% of patients with RA. Among RA patients who switched from iETN, the mean (SD) DAS28-ESR score was 2.2 (0.7) and 2.0 (0.9) at baseline, and Week 24, respectively. The mean (SD) HAQ-DI score was 0.7 (0.6) at baseline, and Week 24. Adverse events (AEs) and serious AEs (SAEs) were reported in 46.2% and 12.3% of patients with RA, respectively (Table 1 [Tab. 1]).
Conclusion: Switch from iETN to SDZ ETN does not impact the effectiveness of ETN in patients with RA, with no new safety signals.
Disclosures: Marc Schmalzing: Speakers bureau: Novartis, AbbVie, Chugai/Roche, Janssen-Cilag, Lilly, Consultant of: AstraZeneca, Chugai/Roche, Hexal/Sandoz, Gilead, AbbVie, Janssen-Cilag, Boehringer/Ingelheim, Grant/research support from: Travel grants: Chugai/Roche, Boehringer/Ingelheim, Celgene, Medac
Silke Zinke: Studies: Biogen, Novartis, Abbvie, Lilly, BMS
Maren Sieburg: Lecturing or consulting activities: Sandoz/Hexal, Novartis, Abbvie, Gilead; Travel expense reimbursement: Boehringer/Ingelheimer, Pfizer; Studies with: Sandoz/Hexal, Novartis, Abbvie, Gilead, BMS, UCB, Lilly, Celltrion, Sanofi-Aventis
Thomas Kupka: Consultant: Amgen, Abbvie, Gilead
Charlotte Both: Employee of Sandoz, Hexal AG
Fabricio Furlan: Employee of Sandoz, Hexal AG
Sohaib Hachaichi: Employee of Sandoz, Hexal AG
Herbert Kellner: None declared
