Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To report on sustainability and consistency of ACR component scores with intravenous (IV) golimumab (GLM) 2mg/kg+methotrexate (MTX) through wk52 in pts with active rheumatoid arthritis (RA).
Methods: 592 pts with active RA (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein (CRP) ≥1.0mg/dL, rheumatoid-factor and/or anti-cyclic-citrullinated-peptide-antibody positive at screening) despite MTX ≥3 months (stable 15-25mg/wk, ≥4wks) participated in this multicenter, international, randomized, double-blind, placebo-controlled Phase 3 study. Pts were randomized (2:1) to IV GLM 2mg/kg or placebo (PBO) infusions at wks0&4 and q8w; pts continued stable MTX. PBO pts started GLM 2mg/kg at wk16 (early escape; <10% improvement in tender&swollen joints) or wk24 (crossover by design), so that all patients received GLM between wks 24-52.
Results: Significant and rapid clinical improvement in all ACR component scores was observed through wk24 (Table). Among pts with ≥20% improvement in ACR20 response or who achieved “good” or “moderate” response per 28-joint disease activity score employing CRP (DAS28-CRP) at wk24, approximately 80% maintained response through wk52. GLM+MTX treatment yielded sustained improvement across ACR components, including swollen and tender joint counts, pt assessments of pain and disease activity, physician assessment of disease activity, and the Health Assessment Questionnaire-Disability Index (Table).
Conclusion: In pts with active RA despite MTX, IV GLM+MTX yielded sustained clinical improvement that was consistent across ACR components, with no new safety signals observed through 1-year.
Table. Median improvement in ACR components through 1-year
|
|
PBO→GLM 2mg/kg +MTX |
GLM 2 mg/kg +MTX |
|
Randomized pts |
197 |
395 |
|
Swollen joints (0-66) Baseline, median % improvement at wk14/24/36/52 |
12.0 25.0%/27.3%/66.7%/81.8% |
12.0 68.2%/75.0/77.8%/85.7% |
|
Tender joints (0-68) Baseline, median % improvement at wk14/24/36/52 |
22.0 12.8%/13.6%/57.9%/68.2% |
24.0 61.5%/64.0%/66.7%/70.6% |
|
Pt pain (0-10 cm VAS) Baseline, median % improvement at wk14/24/36/52 |
6.9 7.4%/10.8%/30.0%/34.7% |
6.5 38.1%/42.9%/41.5%/41.4% |
|
Pt disease activity (0-10 cm VAS) Baseline, median % improvement at wk14/24/36/52 |
6.9 7.3%/13.9%/31.1%/37.0% |
6.6 37.1%/40.5%/40.0%/41.5% |
|
Physician disease activity (0-1- cm VAS) Baseline, median % improvement at wk14/24/36/52 |
6.3 14.5%/23.7%/54.0%/57.4% |
6.3 52.1%/54.5%/59.7%/61.1% |
|
HAQ-DI (0-3) Baseline, median % improvement at wk14/24/36/52 |
1.6 6.7%/8.7%/26.7%/25.0% |
1.6 28.6%/30.0%/31.3%/30.0% |
|
Serum CRP (mg/dL) Baseline, median % improvement at wk14/24/36/52 |
1.7 29.3%/21.4%/56.0%/57.3% |
2.0 77.8%/76.8%/64.9%/65.8% |
|
|
|
|
CRP=C-reactive protein, GLM=golimumab, HAQ-DI=Health Assessment Questionnaire-Disability Index, MTX=methotrexate, PBO=placebo
Disclosure:
C. O. Bingham III,
Janssen Pharmaceutica Product, L.P.,
2,
Janssen Pharmaceutica Product, L.P.,
5,
UCB ,
2,
UCB,
5,
Pfizer,
2,
Pfizer Inc,
5,
AbbVie/Abbott,
5,
Amgen,
5,
BMS,
2,
BMS,
5,
Celgene,
5,
Corrona,
2,
Genetech/Roche,
2,
Genetech/rRoche,
5,
Novartis Pharmaceutical Corporation,
5,
Mesoblast,
2;
R. Westhovens,
BMS,
8,
Janssen; Galapagos,
9,
Roche Pharmaceuticals,
2;
A. M. Mendelsohn,
Janssen Research & Development, LLC.,
3;
L. Kim,
Janssen Research & Development, LLC.,
3;
K. H. Lo,
Janssen Research & Development, LLC.,
3;
M. E. Weinblatt,
Janssen Research & Development, LLC.,
5.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/sustained-and-consistent-clinical-benefit-with-intravenous-golimumab-therapy-in-patients-with-active-rheumatoid-arthritis-despite-methotrexate-therapy-results-through-1-year-of-a-phase-3-rando/