Golimumab, a Human Anti-Tumor Necrosis Factor Monoclonal Antibody, Injected Subcutaneously Every 4 Weeks in Patients With Active Rheumatoid Arthritis Who Had Never Taken Methotrexate: 1-Year and 2-Year Clinical, Radiologic, and Physical Function Findings

Emery, Paul, Fleischmann, Roy M., Doyle, Mittie K., Strusberg, Ingrid, Durez, Patrick, Nash, Peter, Amante, Eric, Churchill, Melvin, Park, Won, Pons-Estel, Bernardo, Xu, Weichun, Xu, Stephen, Wu, Zhong and Hsia, Elizabeth C. (2013) Golimumab, a Human Anti-Tumor Necrosis Factor Monoclonal Antibody, Injected Subcutaneously Every 4 Weeks in Patients With Active Rheumatoid Arthritis Who Had Never Taken Methotrexate: 1-Year and 2-Year Clinical, Radiologic, and Physical Function Findings. Arthritis Care and Research, 65 11: 1732-1742. doi:10.1002/acr.22072


Author Emery, Paul
Fleischmann, Roy M.
Doyle, Mittie K.
Strusberg, Ingrid
Durez, Patrick
Nash, Peter
Amante, Eric
Churchill, Melvin
Park, Won
Pons-Estel, Bernardo
Xu, Weichun
Xu, Stephen
Wu, Zhong
Hsia, Elizabeth C.
Title Golimumab, a Human Anti-Tumor Necrosis Factor Monoclonal Antibody, Injected Subcutaneously Every 4 Weeks in Patients With Active Rheumatoid Arthritis Who Had Never Taken Methotrexate: 1-Year and 2-Year Clinical, Radiologic, and Physical Function Findings
Journal name Arthritis Care and Research   Check publisher's open access policy
ISSN 2151-464X
2151-4658
Publication date 2013-11-01
Sub-type Article (original research)
DOI 10.1002/acr.22072
Open Access Status DOI
Volume 65
Issue 11
Start page 1732
End page 1742
Total pages 11
Place of publication Hoboken, NJ, United States
Publisher John Wiley & Sons
Language eng
Formatted abstract
Objective: To assess 2-year golimumab efficacy/safety in patients with active rheumatoid arthritis (RA) who had never taken methotrexate (MTX).

Methods: RA patients who had never taken MTX (n = 637) were randomized (1:1:1:1) to placebo + MTX (group 1), golimumab 100 mg + placebo (group 2), golimumab 50 mg + MTX (group 3), or golimumab 100 mg + MTX (group 4) every 4 weeks. Nonresponders based on week 28 swollen/tender joint counts changed treatment as follows: group 1 added golimumab 50 mg, group 2 added MTX, group 3 increased golimumab to 100 mg, and group 4 had no change. Most group 1 patients (85%) initiated golimumab 50 mg + MTX at week 28 or subsequently at week 52. After the last patient completed week 52 and blinding was broken, the investigator could escalate golimumab to 100 mg and/or adjust MTX. The co-primary end points (week 24 American College of Rheumatology criteria for 50% improvement [ACR50] response and week 52 change in Sharp/van der Heijde score [SHS]) have been published previously. We now detail week 52 major secondary end points (Health Assessment Questionnaire [HAQ] disability index [DI] scores and SHS among patients with a baseline C-reactive protein [CRP] level >1.0 mg/dl) and week 104 findings.

Results: At week 52 for combined groups 3 and 4 versus group 1, the respective proportions of patients achieving ACR20 and ACR50 responses were 63.2% versus 51.9% (P = 0.017) and 45.3% versus 35.6% (P = 0.044). Respective week 52 mean HAQ DI improvements were 0.70 versus 0.58 (P = 0.053); mean SHS changes were 0.41 versus 1.37 (P = 0.006) among all patients and 0.74 versus 2.16 (P = 0.003) in patients with a CRP level >1.0 mg/dl. Improvements were maintained through week 104. Golimumab + MTX for 2 years yielded statistically less radiographic progression than initial MTX or golimumab 100 mg monotherapy. Golimumab safety profiles through weeks 24, 52, and 104 were generally consistent with those observed in other golimumab studies.

Conclusion: In RA patients who had never taken MTX, up to 2 years of golimumab + MTX yielded sustained improvements in clinical signs/symptoms, physical function, and radiographic progression.
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2014 Collection
School of Medicine Publications
 
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