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Real-life persistence of golimumab in patients with chronic inflammatory rheumatic diseases: results of the 2-year observational GO-PRACTICE study


1, 2, 3, 4, 5, 6, 7, 8

 

  1. Rheumatology Department, Lille University Hospital, Lille, France.
  2. 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 Pharmacoépidemiologie (Cephepi) CIC-1422, Paris, France.
  3. Rheumatology Department, Tours University Hospital, Tours, France.
  4. Rheumatology Department, Orléans Regional Hospital, Orléans, France.
  5. MSD France, Puteaux, France. naoual.harid@msd.com
  6. ClinSearch, Scientific Department, Medical Device and Drug Development, Malakoff, France.
  7. Rheumatology Department, Limoges University Hospital, Limoges, France.
  8. 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 Pharmacoépidemiologie (Cephepi) CIC-1422, Paris, France.

CER13251
2021 Vol.39, N°3
PI 0537, PF 0545
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PMID: 32896246 [PubMed]

Received: 24/02/2020
Accepted : 18/05/2020
In Press: 03/09/2020
Published: 21/05/2021

Abstract

OBJECTIVES:
GO-PRACTICE aimed to evaluate the persistence, clinical response and safety of golimumab in adult patients with chronic inflammatory rheumatic disease.
METHODS:
Prospective observational study with 24 months of follow-up, involving 134 rheumatologists from public or private health establishments in France. The primary outcome was the persistence of golimumab 24 months after initial prescription. Cumulative persistence probabilities were determined from Kaplan-Meier estimates. Secondary outcomes included an evaluation of disease activity and golimumab safety profile.
RESULTS:
Of 754 consecutively recruited patients, 170 had rheumatoid arthritis (RA) (54.3 years, 74.1% female, 64.7% biologics-naïve), 106 had psoriatic arthritis (PsA) (48.1 years, 70% female, 66.0% biologics-naïve) and 478 had axial spondyloarthritis (axSpA) (42.8 years, 54.6% female, 60.9% biologics-naïve). Golimumab persistence at 2 years was 56.5%, 45.1% and 52.6%, respectively, in RA, PsA and axSpA groups. Persistence was higher in biologics-naïve (58.3%) than in biologics pre-treated patients (42.7%, p<0.01). For 362 patients continuing golimumab at 2 years, disease activity improved significantly from baseline to 2 years: mean 28-joint disease activity score for RA and PsA was lowered by 2.06 and 1.89 points, and mean ankylosing spondylitis disease activity score was lowered by 3.11 points (p<0.0001) for axSpA. Patient appreciation of disease activity also improved; 8.9% of discontinuations were due to intolerance.
CONCLUSIONS:
Golimumab persistence was satisfactory at 2 years and accompanied by improvements in clinical effectiveness in 362 patients continuing golimumab at 2 years. Golimumab was well tolerated and its safety profile was consistent with those reported in previous studies.

Rheumatology Article