Article
Effectiveness and safety of GP2015 in patients with rheumatoid arthritis in Germany: Final results of 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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Shrihari Jathanakodi
- Sandoz Hexal AG, Holzkirchen
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Herbert Kellner
- Center for Rheumatology and Gastroenterology, Hospital Neuwittelsbach, Munich
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Silke Zinke
- Rheumapraxis Berlin-Lichtenberg, Berlin
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Charlotte Both
- Sandoz Hexal AG, Holzkirchen
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Thomas Alexander Kupka
- Rheumazentrum Kupka, Altenburg
| Published: | August 30, 2023 |
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Outline
Text
Introduction: COMPACT, a non-interventional study evaluated the persistence, effectiveness, and safety in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial-spondyloarthritis (axSpA) treated with GP2015 (an etanercept [ETN] biosimilar) in real-world conditions. Herein, we report the effectiveness and safety data from the study, focusing on German RA patients who were in clinical remission or had low disease activity (LDA) under treatment with reference ETN or other biosimilar ETN [iETN] or who were biologic-naïve and treated with GP2015.
Methods: Patients (≥18 years) who have been treated with GP2015 were categorized based on prior treatment status (Groups A–D): patients in clinical remission or LDA under treatment with reference ETN or iETN and switched to GP2015, patients who received non-ETN–targeted therapies and switched to GP2015, biologic-naïve patients who started GP2015 after conventional therapy failure and DMARD-naïve RA patients considered suitable for treatment initiation with GP2015 as first line biologic. Effectiveness and patient-reported outcomes assessed through Month 12 included Disease Activity Score 28-joint count Erythrocyte Sedimentation Rate (DAS28-ESR) and Health Assessment Questionnaire Disability Index (HAQ-DI).
Results: A total of 458 patients (RA, n=285; PsA, n=79; axSpA, n=94) were recruited from Germany. Of the 285 patients with RA, 65 were switched from iETN and 189 were biologic-naïve. After 12 months of treatment with GP2015, patients achieved comparable DAS28 scores and HAQ-DI scores when switched from iETN. No major difference was seen in the patients who were biologic naïve and started GP2015 as their first line biologic from baseline to month 12 for DAS28 and HAQ-DI (Table 1 [Tab. 1]). Across patient groups no major differences were observed in the disease activity scores and PRO between baseline and Month 12 that may be explained by the ongoing GP2015 treatment before enrolment. Rate of Injection site reaction was low across the groups (Table 1 [Tab. 1]).
Conclusion: Switch from iETN to GP2015 does not impact the effectiveness and safety of ETN in patients with RA. No new safety signals were reported.These data are consistent with the results reported for the overall population [1].
References
- 1.
- Schmalzing M, Kellner H, Askari A, de Toro Santos J, Vazquez Perez-Coleman JC, Foti R, Jeka S, Haraoui B, Allanore Y, Rahman M, Furlan F, Hachaichi S, Sheeran T. Real-world effectiveness and safety of GP2015 in patients with rheumatic diseases: final results of the compact study. Annals of the Rheumatic Diseases 2022;81:589-90.
