Full Papers
Real-life golimumab persitence in patients with axial spondyloarthritis: post-hoc results of the prospective observational cohort study, GO-PRACTICE
P. Goupille1, P. Bertin2, F. Tubach3, E. Lespessailles4, N. Harid5, S. Sequeira6, J.-M. Fayette7, B. Fautrel8, R.-M. Flipo9
- Université de Tours, EA 7501, GICC, Service de Rhumatologie, Centre Hospitalier Universitaire de Tours, France.
- Service de Rhumatologie, Centre Hospitalier Universitaire de Limoges, France.
- Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, AP-HP, Sorbonne Université, Hôpital Pitié Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie (Cephepi), Unité de Recherche Clinique PSL-CFX, CIC-1422, Paris, France.
- Service de Rhumatologie, Centre Hospitalier Régional d’Orléans, France.
- MSD France, Puteaux, France. naoual.harid@msd.com
- ClinSearch, Scientific Department, Medical Device and Drug Development, Malakoff, France.
- ClinSearch, Scientific Department, Medical Device and Drug Development, Malakoff, France.
- Sorbonne Université, INSERM, Institut Pierre Louis d’Epidémiologie et de Santé Publique, AP-HP, Sorbonne Université, Hôpital Pitié Salpêtrière, Service de Rhumatologie, Paris, France.
- Université de Lille, Service de Rhumatologie, Hôpital Roger Salengro, Lille, France.
CER14656
2022 Vol.40, N°7
PI 1352, PF 1360
Full Papers
PMID: 34936548 [PubMed]
Received: 24/03/2021
Accepted : 26/07/2021
In Press: 22/12/2021
Published: 04/07/2022
Abstract
OBJECTIVES:
To evaluate in clinical practice the persistence and safety of golimumab, together with the evolution of disease activity and patient reported outcomes, in adult patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis (axSpA). This article focuses on the outcomes of golimumab treatment in axSpA patients.
METHODS:
Golimumab persistence 24 months after initial prescription (primary outcome) was assessed using Kaplan-Meier estimates. Secondary outcomes included evaluations of disease activity evolution (ASDAS and BASDAI), patient-reported outcomes (EQ-5D, SF-12 and HAQ), and golimumab’s safety profile.
RESULTS:
Of 478 axSpA patients, 60.9% were biologic-naïve. Mean age and proportion of females were higher in biologics-pretreated patients (46.8 vs. 40.2 years, p<0.001 and 62.0% vs. 49.8%, p=0.009, respectively). Golimumab persistence at 24 months was 52.6% [95% CI 47.9–57.1%] in the axSpA cohort. It was 59.2% [95% CI 53.1–64.8%] and 42.7% [95% CI 35.3–49.8%] respectively, for biologics-naïve and biologics-pretreated patients (p<0.01), and 65.9% [95% CI 58.9–72.0%] and 41.5% [95% CI 35.2–47.6%], respectively for males and females (p<0.01). Reasons for golimumab discontinuation were primary non-response (37.4%), secondary non-response (24.8%) and intolerance (21.5%). Disease activity and patient reported outcomes improved significantly for those who persisted at 24 months and were higher for biologics-naïve patients.
CONCLUSIONS:
Golimumab persistence at 2 years in axSpA patients was 52.6%. Previous treatment with another biologic and female gender were associated with earlier discontinuation. Golimumab was a well-tolerated therapy for axSpA, with no new safety signals observed.
