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Reumatol Clin. 2015 May-Jun;11(3):144-50. doi: 10.1016/j.reuma.2014.05.002. Epub 2014 Jul 10.

Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs in rheumatoid arthritis: results of the GO-MORE study in Spain.

Author information

  • 1Departamento de Reumatología, Hospital de Cruces, Barakaldo, Vizcaya, España.
  • 2Departamento de Reumatología, Hospital Universitario Gregorio Marañón, Madrid, España.
  • 3Departamento de Reumatología, Hospital Universitario Central de Asturias, Oviedo, Asturias, España.
  • 4Departamento de Reumatología, Hospital Universitario de Basurto, Bilbao, Vizcaya, España.
  • 5Departamento de Reumatología, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, España.
  • 6Departamento de Reumatología, Hospital Universitario de Valme, Sevilla, España.
  • 7Departamento de Reumatología, Hospital Regional Carlos Haya, Universidad de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, España.
  • 8Departamento de Reumatología, Hospital de Cabueñes, Gijón, Asturias, España.
  • 9Departamento de Medical Affairs, Merck Sharp & Dohme de España. Electronic address: luis.cea@merck.com.
  • 10Departamento de Medical Affairs, Merck Sharp & Dohme de España.
  • 11Hospital Clínic i Provincial, Barcelona, España.

Abstract

OBJECTIVES:

To assess the efficacy and safety of golimumab in the 140 patients included in Spain as the first part of the GO-MORE trial, a multinational study involving patients with active rheumatoid arthritis (RA) despite treatment with different disease-modifying antirheumatic drugs (DMARDs).

PATIENTS AND METHODS:

The patients received subcutaneous golimumab 50mg once a month during 6 months. The primary endpoint was the percentage of individuals with a good or moderate EULAR DAS28-ESR response after 6 months of treatment.

RESULTS:

A total of 140 patients were included. Of these, 76.4% had very active disease (DAS28-ESR>5.1). 76.4% were taking methotrexate, 40.0% other DMARDs in monotherapy or combined, and 65.0% received corticosteroids. After 6 months, 82.9% of the patients showed a good or moderate EULAR response, 41.4% had low disease activity, and 30.7% were in remission. The percentage of responders one month after the first dose was 69.3%. The efficacy was similar in patients treated with methotrexate or other DMARDs, with different methotrexate doses, with or without corticosteroids, or in subjects who had failed one or more DMARDs. The response to golimumab was observed from the first dose. Golimumab was well tolerated and its safety profile was consistent with the findings of previous studies. Serious adverse events were reported in 11 patients (7.9%).

CONCLUSION:

The addition of subcutaneous golimumab 50 mg once a month to different DMARDs in patients with active RA yielded a moderate or good response after 6 months in 82.9% of the cases. The response was observed early, from the start of the second month, after a single dose of golimumab.

Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

KEYWORDS:

Artritis reumatoide; Disease modifying anti-rheumatic drugs; EULAR response; Fármacos antirreumáticos modificadores de la enfermedad; Golimumab; Respuesta EULAR; Rheumatoid arthritis

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