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AB0456 Improvement and maintenance of hemoglobin levels among rheumatoid arthritis, psoriatic arthritis & ankylosing spondylitis patients with anemia of inflammation after treatment with golimumab: 3 yr pooled analysis from golimumab rheumatology clinical program
  1. D.E. Furst1,
  2. T.A. Gathany2,
  3. J. Kay3,
  4. M.C. Wasko4,
  5. E. Keystone5,
  6. A. Kavanaugh6,
  7. A. Deodhar7,
  8. F. Murphy8,
  9. C. Han9,
  10. M.K. Doyle10,11
  1. 1Univ of California, Los Angeles, CA
  2. 2Janssen Global Service, LLC, Malvern, PA
  3. 3UMass Memorial, Worcester, MA
  4. 4West Penn Allegheny, Pittsburgh, PA, United States
  5. 5Mt. Sinai Hosp, Toronto, ON, Canada
  6. 6Univ of California, San Diego, CA
  7. 7Oregon Health and Science Univ, Portland, OR
  8. 8Altoona Center of Clinical Research, Duncansville, PA
  9. 9Janssen Global, Malvern, PA
  10. 10Janssen R&D, Spring House, PA
  11. 11U Penn, Philadelphia, PA, United States

Abstract

Objectives The purpose of this analysis was to determine the long-term effects of golimumab (GLM) on anemia of inflammation (AOI) in patients (pts) with RA, PsA, and AS.

Methods Data through 3 yrs were pooled from 5 studies in the GLM rheumatology clinical program including: 3 RA studies (GO-BEFORE, GO-FORWARD, GO-AFTER), 1 PsA study (GO-REVEAL), and 1 AS study (GO-RAISE). SC placebo (PBO) or GLM (50mg or 100mg) was administered q4wks in the randomized portions of the ongoing Ph3 trials. At 6 months/1 yr, pts remaining in the studies entered long term extensions (LTE) and received GLM 50mg or 100mg q4wks in an unblinded fashion. Dose escalation from 50mg to 100mg was allowed; no dose reduction was permitted.Primary endpoints compared pts treated with GLM±MTX with pts receiving placebo (PBO±MTX). Pts were defined as anemic if their hemoglobin (Hgb) were below the age- and sex-specific normal range of the central laboratory (Quintiles Laboratories, Smyrna, GA, United States). Normal Hgb for the central laboratory was 11.6 to 16.2 g/dL for women aged ≤65 yrs, 11.0 to 16.1 g/dL for women aged ≥66 yrs, 13.0 to 17.5 g/dL for men aged ≤65 yrs, and 12.6 to 17.7 g/dL for men aged ≥66 yrs. A subset of pts with AOI (anemic and ferritin ≥60 ng/mL), at baseline (BL) was analyzed for normalization and improvement of Hgb levels at 6 months; the long-term maintenance of these improvements were analyzed at yrs 1,2, and 3.

Results At 6 months, among pts who had AOI at BL, pts treated with GLM±MTX showed greater Hgb improvements vs pts treated with PBO±MTX (median improvement: 1.45 g/dL vs 0.55 g/dL, p<0.001) at 6 months. More GLM±MTX-treated pts achieved normal Hgb (67.9% vs 42.3%, p=0.020). 93.0% to 96.7% of these pts maintained normal Hgb at 1-, 2- and 3yrs(Table).

Conclusions Among pts with RA, PsA and AS with AOI at BL, pts treated with GLM±MTX achieved greater median improvements in Hgb and greater proportions had normalized Hgb levels at 6 months. Pts who achieved normal levels at 6 months and continued treatment with GLM, maintained the normal Hgb levels through 3 yrs. These improvements in AOI support the hypothesis that AOI responds to suppression of inflammation with GLM.

Disclosure of Interest D. Furst Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, T. Gathany Employee of: Janssen Global Service, LLC, J. Kay Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, M. Wasko Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, E. Keystone Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, A. Kavanaugh Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, A. Deodhar Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, F. Murphy Grant/Research support from: Investigators for Janssen Research & Development, LLC sponsored clinical study, C. Han Employee of: Janssen Global Service, LLC, M. Doyle Employee of: Janssen Research & Development, LLC

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