Ayman Askari1, Marc Schmalzing2, Herbert Kellner3, Rafaela Ortega-Castro4, Julio Cesar Vázquez Perez-Coleman5, Foti Rosario6, Sławomir Jeka7, Boulos Haraoui8, Yannick Allanore9, Masiur Rahman10, Fabricio Furlan10, Sohaib Hachaichi11 and Tom Sheeran12, 1The Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry, England, United Kingdom, 2University Hospital Wuerzburg, Wuerzburg, Germany, 3Schwerpunktpraxis für Rheumatologie und Gastroenterologie, Munich, Germany, 4IMIBIC/University of Cordoba/Reina Sofia Hospital, Cordoba, Spain, 5University Hospital Complex of Ferrol, A Coruña, Spain, 6Policlinico G. Rodolico-S.Marco Hospital, Catania, Italy, 7University Hospital No 2 in Bydgoszcz Collegium Medicum UMK, Clinic and Department of Rheumatology and Connective Tissue Diseases, Bydgoszcz, Poland, 8Institut de rhumatologie de Montréal, Montréal, QC, Canada, 9Department of Rheumatology A, Descartes University, APHP, Cochin Hospital, Paris, France, Paris, France, 10Sandoz Hexal AG, Holzkirchen, Germany, 11Hexal AG (A Sandoz company), Holzkirchen, Germany, 12New Cross and Cannock Chase Hospitals, University of Wolverhampton, Cannock, United Kingdom
Background/Purpose: COMPACT is a non-interventional study evaluating the persistence, effectiveness, safety and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA), axial-spondyloarthritis or psoriatic arthritis treated with GP2015 (an etanercept [ETN] biosimilar) in real-world conditions.1 Here we present the PROs and quality of life (QoL) in RA patients treated with GP2015, final results from the COMPACT study.
Methods: Patients with RA aged ≥18 years who initiated treatment with GP2015 were enrolled in this study.1 Patients were categorized based on prior treatment status: patients with clinical remission or low disease activity under treatment with reference ETN or biosimilar ETN (iETN) and switched to GP2015 (Group A) or patients who received non-ETN targeted therapies and switched to GP2015 (Group B) or biologic-naïve patients who started GP2015 after conventional therapy failure (Group C) or disease modifying anti-rheumatic drug (DMARD)-naïve patients with recent diagnosis of RA considered suitable for treatment initiation with a biologic and started on treatment with GP2015 (Group D). PROs and QoL were assessed using health assessment questionnaire-disability index (HAQ-DI), short form health survey 12-item (SF-12)-physical/mental health, EuroQol-5D overall self-rated health status (EQ-5D visual analogue scale [VAS]), functional assessment of chronic illness therapy (FACIT)-fatigue, fatigue VAS, basic pain inventory (BPI)-interference score, pain VAS scores and overall pain (experience of pain during current day) scores.
Results: The recruited patients had an ongoing GP2015 treatment at the time of enrolment for an average of 138 days. A total of 844 RA patients were observed, of whom 73.0% (n = 616) were female. The mean age and BMI of patients enrolled in the study were 57.9 years and 27.1kg/m2, respectively. The total number of patients enrolled to Groups A, B, C and D were 295, 88, 451 and 10, respectively. PRO and QoL for patients in Groups A, B and C were assessed in terms of physical function, health related QoL, fatigue and pain. The results showed comparable scores between Group A (switched patients) and Group C (biologic-naïve patients) through 12 months of treatment with GP2015 in RA patients. Numerically different scores were observed in Group B (patients who received non-ETN targeted therapies and switched to GP2015) (Table). No results were analyzed for patients in Group D due to low number of patients (n = 10). Across all patient groups, no major differences were observed between baseline and Month 12, which may be explained by ongoing GP2015 treatment at the time of enrolment.
Conclusion: This final analysis showed comparable PRO and QoL scores obtained after 12 months of observation in patients with RA who switched from iETN to GP2015 and patients who were biologic-naïve and started GP2015 after conventional therapy failure.
Reference
Schmalzing M, et al. ACR 2019, Atlanta, GA, United States. Poster No. 553.
Table: Summary statistics of various PRO and QoL paraments across treatment groups through Month 12 Disclosures: A. Askari, None; M. Schmalzing, Novartis, AbbVie, AstraZeneca, Chugai/Roche, Janssen, Gilead, Boehringer/Ingelheim, Celgene, Medac, UCB, Sandoz; H. Kellner, Merck/MSD; R. Ortega-Castro, None; J. Perez-Coleman, Sandoz, Abbvie, Sanofi, Fresenius; F. Rosario, Abbivie, Gilead, Lilly, Pfizer, UCB, Roche, Novartis; S. Jeka, None; B. Haraoui, AbbVie, Amgen, Fresenius Kabi, Eli Lilly, Pfizer; Y. Allanore, Boehringer Ingelheim, Sanofi, Janssen, AbbVie, Menarini, Curzion, Medsenic, Prometheus, AstraZeneca; M. Rahman, Sandoz; F. Furlan, Sandoz; S. Hachaichi, Sandoz Hexal AG; T. Sheeran, UCB, Pfizer, Roche, Novartis.
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Table: Summary statistics of various PRO and QoL paraments across treatment groups through Month 12