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THU0127 Intravenous Golimumab Therapy Improves Hemoglobin, Resulting in Reduced Anemia, Improved Physical Function and Fatigue in Patients with Moderate To Severe Rheumatoid Arthritis: Results from Go-Further Phase III Clinical Trial
  1. C. Han1,
  2. M.E. Weinblatt2,
  3. R. Westhovens3,
  4. L. Kim4,
  5. E.C. Hsia4,
  6. D. Parenti5,
  7. S. Kafka5,
  8. C.O. Bingham III6,
  9. on behalf of the GO-FURTHER Investigators
  1. 1Johnson & Johnson Pharmaceutical Services, Malvern
  2. 2Brigham & Women's Hospital, Boston, United States
  3. 3Rheumatology, UZ KU Leuven, Leuven, Belgium
  4. 4Janssen Research & Development, Spring House
  5. 5Janssen Scientific Affairs, Horsham
  6. 6Johns Hopkins University, Baltimore, United States

Abstract

Background Clinical studies demonstrated that patients with rheumatoid arthritis (RA) experience lower hemoglobin level and higher prevalence of anemia than general population.

Objectives This study was to examine the treatment effect of intravenously administered golimumab on improving hemoglobin (Hgb) level, and relieving anemia and anemia-related outcomes among patients with RA using data from the phase III clinical trial GO-FURTHER.

Methods In the GO-FURTHER trial, adult patients with active RA were randomized to placebo + MTX (PBO group) or GLM (2mg/kg) plus MTX at week 0, 2, and every 8 weeks thereafter (GLM group). Patients in placebo group with <10% improvement in tender and swollen joint count from baseline at week 16 entered early escape (EE) and received a 2 mg/kg golimumab infusion at Weeks 16 and 20. In this post hoc analysis, Hgb was assessed at baseline, week 4, 12, 20, 28, 44. Anemia was defined based on World Health Organization (WHO) criteria as Hgb <12 g/dl in women and <13 g/dl in men. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT fatigue) Scale, SF-36 vitality scale, and Health Assessment Questionnaire (HAQ) were collected. Pearson's correlation and linear regression model were used to test correlation. Comparisons between groups at Week 12 before EE were performed using t-test for numeric variables or Mantel-Haenszel Chi-square test for dichotomous variable.

Results At baseline, mean (SD) of Hgb was 12.1 (1.39) g/dl in female and 13.8 (1.29) g/dl in male, and 40.8% female patients and 23.4% male patients had anemia. Significantly greater improvement in hemoglobin in the GLM-treated patients than patients in the placebo group was observed as early as Week 4. At Week 12, mean improvement in Hgb was 0.34g/dl in male and 0.69g/dl in female in the GLM group, compared to an improvement of 0.01g/dl in male (p<0.001) and 0.07g/dl in female (p<0.001) in the PBO group; and greater proportion of patients in the GLM group achieved an increase of ≥1g/dl in Hgb than PBO group. Among patients who had anemia at baseline, prevalence of anemia at Week 12 was 66.4% in female, and 26.3% in male in the GLM-treated patients, compared to 75% in female and 33.3% in male in placebo-treated patients. After adjusting for baseline anemia and gender difference, GLM-treated patients were more likely to have an improvement of ≥1g/dl in Hgb with a Relative Risk (RR) of 1.87 (p<0.001), and less likely to have anemia (RR =0.73, p<0.001) at Week 12. Improvement in Hgb at Week 12 was correlated with improvement in HAQ-DI (r=0.16, p<0.001), FACIT-fatigue (r=0.10, p<0.001) and SF-36 vitality score (r=0.12, p<0.01). Treatment effect of intravenous golimumab on Hgb was maintained through Week 112.

Conclusions Intravenously administered golimumab therapy improves Hgb, resulting in reduced anemia, improved physical function and fatigue in patients with moderate to severe active RA despite MTX.

Disclosure of Interest C. Han Employee of: Johnson & Johnson Pharmaceutical Services, M. Weinblatt Grant/research support from: Janssen R & D, LLC, R. Westhovens Grant/research support from: Janssen R & D, LLC, L. Kim Employee of: Janssen R & D, LLC, E. Hsia Employee of: Janssen R & D, LLC, D. Parenti Employee of: Janssen Scientific Affairs, LLC, S. Kafka Employee of: Janssen Scientific Affairs, LLC, C. Bingham III Grant/research support from: Janssen R & D, LLC

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