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ACR Meeting Abstracts

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Abstract Number: 2495

Impact of Golimumab on Physical Function and Employability of Patients with Rheumatoid Arthritis:   5-Year Data from 3 Phase III Clinical Trials

Chenglong Han1, Edward C. Keystone2, Roy Fleischmann3, Josef Smolen4, Eric L. Matteson5, Paul Emery6, Mark C Genovese7, Timothy A. Gathany1 and Elizabeth C. Hsia8,9, 1Janssen Global Services, LLC., Malvern, PA, 2University of Toronto, Mount Sinai Hospital, Toronto, ON, Canada, 3Southwestern Medical Center, Department of Medicine, Metroplex Clinical Research Center, University of Texas, Dallas, TX, 4Medical University of Vienna and Hietzing Hospital, Vienna, Austria, 5Rheumatology, Mayo Clinic, Rochester, MN, 6Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom, 7Stanford University Medical Center, Palo Alto, CA, 8Janssen Research & Development, LLC., Spring House, PA, 9University of Pennsylvania, Philadelphia, PA

Meeting: ACR/ARHP Annual Meeting 2014

Keywords: ,

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Therapeutic Strategies, Biomarkers and Predictors of Outcomes in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose: 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.

Conclusion: 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:

C. Han,

Janssen Global Services, LLC.,

3;

E. C. Keystone,

Abbott Laboratories, Amgen Inc., AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Janssen Inc, Lilly Pharmaceuticals, Novartis Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, UCB. ,

2,

Abbott Laboratories, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, F. Hoffmann-La Roche Inc, Genentech Inc, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, UCB. ,

5,

Abbott Laboratories, Astrazeneca LP, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Pfizer Pharmaceuticals, UCB, Amgen.,

8;

R. Fleischmann,

AbbVie, Amgen, Ardea, Astra Zeneca, BMS, Celgene, GSK, Janssen, Eli Lilly, Merck, Pfizer, Resolve, Roche, Sanofi Aventis, UCB.,

2,

AbbVie, Akros, Amgen, Antares, Ardea, Astra Zeneca, Augurex, BMS, Celgene, Covagen, Five Prime, GSK, Iroko, Janssen, Eli Lilly, McNeil, Merck, Pfizer, Plexxicon, Resolve, Roche, Sanofi Aventis, Teva, UCB, Vertex. ,

5;

J. Smolen,

Abbott, BMS, Janssen, MSD, Pfizer, Roche, and UCB,

2;

E. L. Matteson,

Janssen Research & Development, LLC.,

2,

Janssen Research & Development, LLC.,

5;

P. Emery,

Janssen Research & Development, LLC.,

2,

Janssen Research & Development, LLC.,

5;

M. C. Genovese,

Janssen Research & Development, LLC.,

2;

T. A. Gathany,

Janssen Global Services, LLC.,

3;

E. C. Hsia,

Janssen Research and Development, LLC.,

3.

ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-golimumab-on-physical-function-and-employability-of-patients-with-rheumatoid-arthritis-5-year-data-from-3-phase-iii-clinical-trials/