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THU0156 Impact of Golimumab on Physical Function and Employability of Patients with Rheumatoid Arthritis: 5-Year Data from 3 Phase III Clinical Trials
  1. C. Han1,
  2. E. Keystone2,
  3. R. Fleischmann3,
  4. J. Smolen4,
  5. E.L. Matteson5,
  6. P. Emery6,
  7. M. Genovese7,
  8. T. Gathany1,
  9. E.C. Hsia8
  1. 1Johnson & Johnson Pharmaceutical Services, LLC, Malvern, United States
  2. 2University of Toronto, Toronto, Canada
  3. 3University of Texas Southwestern Medical Center at Dallas, Dallas, United States
  4. 4Medical University of Vienna and Hietzing Hospital, Vienna, Austria
  5. 5Mayo Clinic, Rochester, United States
  6. 6Leeds Musculoskeletal Biomedical Research Unit and University of Leeds, Leeds, United Kingdom
  7. 7Stanford University, Palo Alto
  8. 8Janssen Research & Development, LLC/Univ. of Pennsylvania, Spring House/Philadelphia, United States

Abstract

Objectives To assess the impact of golimumab (GLM) on physical function and employability in patients with rheumatoid arthritis (RA) with various prior treatment histories, after 5 years of therapy.

Methods The efficacy and safety of GLM were assessed in methotrexate (MTX)-naïve RA patients (GO-BEFORE, N=637), patients with inadequate response to MTX (GO-FORWARD, N=444), and patients previously treated with TNF-inhibitors (TNFi, GO-AFTER, N=445). Patients with active RA were randomized to placebo (PBO), GLM 100mg+PBO (GO-BEFORE and GO-FORWARD), or GLM (50 or 100mg), q4w. Patients in GO-BEFORE and GO-FORWARD could receive concomitant MTX or no MTX and crossed-over to GLM after wk24 (GO-FORWARD) OR wk52 (GO-BEFORE), while patients in GO-AFTER were on background (with or without) MTX and crossed-over to GLM after wk24. Clinical remission was defined as DAS28 (ESR) <2.6. Physical function was measured using Health Assessment Questionnaire (HAQ) and employability was defined as being employed or being able to work if job was available (Yes/No). 5 year data were presented by 3 patient populations.

Results At baseline, the percent of patients with disability (HAQ-DI score >0.5) in each of 3 RA populations were 90.9% in patients who were MTX-naïve, 87.6% in patients who were MTX-inadequate responders and 92.3% in patients who were TNFi-experienced. Among the analyzed patient population for employability (not retired and age<65 years), the percent of patients unemployable due to their RA at baseline were 9% in MTX-naïve patients, 8.1% in MTX-inadequate responders and 13.1% in TNF-experienced patients. After treatment with GLM, among those who had disability at baseline, 46.8% of MTX-naive patients, 37.5% of MTX-inadequate responders and 27.5% of TNFi-experienced patients had no disability (HAQ-DI score≤0.5) at wk256; among patients unemployable at baseline, 29.5% of MTX-naive patients, 28.6% of MTX-inadequate responders and 5.4% of TNFi-experienced patients regained employability at wk256. Similar trends of better outcomes on disability and employability of MTX-naïve patients were observed among those who achieved remission at wk256: 65.1% in MTX- naive patients, 54.4% in MTX-inadequate responders and 53.1% in TNFi-experienced patients achieved no disability; and 73.3% in MTX-naive patients, 50% in MTX-inadequate responders and 50.0% in TNFi-experienced patients regained employability.

Conclusions This analysis indicates that effective treatment at an early stage may result in reduction in disability and improvement in employability over the long-term.

Disclosure of Interest : C. Han Employee of: Janssen Research & Development, LLC., E. Keystone Grant/research support: Janssen Research & Development, LLC., R. Fleischmann Grant/research support: Janssen Research & Development, LLC., J. Smolen Grant/research support: Janssen Research & Development, LLC., E. Matteson: None declared, P. Emery Grant/research support: Janssen Research & Development, LLC., M. Genovese Grant/research support: Janssen Research & Development, LLC., T. Gathany Employee of: Johnson & Johnson Pharmaceutical Services, LLC, E. Hsia Employee of: Janssen Research & Development, LLC.

DOI 10.1136/annrheumdis-2014-eular.2535

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