gms | German Medical Science

43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Prediction of Remission and Low Disease Activity in DMARD-Refractory Patients with RA Treated with Golimumab

Meeting Abstract

  • Nathan Vastesaeger - Merck Sharp & Dohme Corp., Brüssel, Belgium
  • Patrick Durez - Université Catholique de Louvain, Brüssel, Belgium
  • Bhaskar Dasgupta - Southend University Hospital, Westcliff-on-Sea, United Kingdom
  • Bernard Combe - Montpellier University, Montpellier, France
  • Hendrik Schulze-Koops - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München
  • Ingrid Louw - Panorama Medical Centre, Cape Town, South Africa
  • Jürgen Wollenhaupt - Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und klinische Immunologie, Hamburg
  • Cristiano Zerbini - Centro Paulista de Investigação Clinica, São Paulo, Brazil
  • André Beaulieu - Centre de Rhumatologie, St-Louis, Canada
  • Karel Pavelka - Charles University, Institute of Rheumatology and Clinic of Rheumatology, Prague, Czech Republic
  • Maria Lazaro - IARI Instituto de Asistencia Reumatologica Integral, Buenos Aires, Argentina
  • Abraham Garcia Kutzbach - AGAR Francisco Marroquin University, Guatemala City, Guatemala
  • Robert J. Moots - University Hospital Aintree, Liverpool, United Kingdom
  • Howard Amital - Sheba Medical Center, Tel-Hashomer, Israel
  • Susan Huyck - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • B. Fu - Merck & Co., Inc., Whitehouse Station, NJ, USA
  • Marinella Govoni - Merck Sharp & Dohme Corp., Rom, Italien

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocRA.29

doi: 10.3205/15dgrh197, urn:nbn:de:0183-15dgrh1975

Published: September 1, 2015

© 2015 Vastesaeger et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Introduction: EULAR recommendations for RA therapy suggest addition of a biologic only if poor prognostic factors such as high disease activity are present. However, low baseline disease activity is associated with better biologic treatment outcomes.

Objective: To develop a tool to predict remission/low disease activity (LDA) and aid in selection of patients for anti-TNF treatment.

Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA despite DMARD-therapy. Patients received 50-mg SC golimumab (GLM) once monthly for 6 months along with their background DMARDs. Predictors of DAS28-ESR LDA and remission at 6 months were evaluated with univariate/multivariable regression models and receiver operating characteristic (ROC) analyses. To assess the relationship between predicted disease states and observed amount of improvement, further analyses evaluated associations between final regression model’s predicted rate of remission and observed 6-month improvements in DAS28, Health Assessment Questionnaire (HAQ), and EurolQoL 5-Dimension (EQ-5D).

Results: The analysis included 3280 patients: 82.8% female, mean age 52.3 years, mean disease duration 7.6 years, mean baseline DAS28–ESR 5.97 (standard deviation=1.095). DAS28-ESR remission and LDA were achieved by 23.9% and 37.4% of patients, respectively, after 6 months of GLM-therapy. In multiple regression models, remission at 6 months was associated with male sex, absence of comorbidities, and lower age, HAQ, ESR, and TJC28. The final model included sex, comorbidities, age, HAQ, ESR, and TJC28 as continuous variables and had an area under the ROC curve of 0.71 to predict remission and LDA at 6 months. When CRP replaced ESR or SJC28 replaced TJC28, predictive ability was slightly reduced. Predicted remission rates ranged from 4% to 67% in females (figure) and from 7% to 76% in males. Patients who were predicted to be least likely to reach DAS28 remission (who also had the highest baseline disease activity) had the greatest improvements in DAS28, HAQ, and EQ-5D scores during 6 months of GLM treatment.

Figure1 [Fig. 1]

Conclusion: Baseline sex, age, ESR, HAQ, absence of comorbidities, and TJC28 were predictive of remission and LDA after 6 months of GLM treatment. Patients with lower likelihood of remission still experienced improvements in DAS28, HAQ, and EQ-5D during treatment.