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FRI0128 Integrated safety data analysis across phase 3 clinical studies for intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis
  1. M.E. Husni1,
  2. S. Schwartzman2,
  3. A. Deodhar3,
  4. S. Kafka4,
  5. S.D. Chakravarty5,
  6. E.C. Hsia6,
  7. D.D. Harrison7,
  8. J.H. Leu8,
  9. Y. Zhou8,
  10. K.H. Lo8,
  11. A. Kavanaugh9
  1. 1Cleveland Clinic, Cleveland
  2. 2Weill Cornell Medical College, New York
  3. 3Oregon Health and Science U, Portland
  4. 4Janssen Scientific Affairs, LLC
  5. 5Janssen Scientific Affairs, LLC/Drexel U College of Med, Horsham
  6. 6Janssen Research and Development, LLC/U Penn, Spring House/Phila
  7. 7Janssen Research and Development, LLC, Horsham
  8. 8Janssen Research and Development, LLC, Spring House
  9. 9UCSD, San Diego, USA


Background Intravenous golimumab (IV GLM) is approved for treatment of adults w/rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

Objectives To present the integrated safety data from three Phase 3 studies of IV GLM in patients (pts) w/RA, PsA and AS up to 24 weeks (wks). Safety outcomes in pts receiving concomitant methotrexate (MTX) and low-dose oral corticosteroids (CS) were assessed when used in treatment of the indicated disease.

Methods Integrated safety data from Phase 3 double-blind placebo-controlled trials (RA [GO-FURTHER], PsA [GO-VIBRANT] and AS [GO-ALIVE]) were analysed up to wk24. In general, pts received either IV PBO or IV GLM (2 mg/kg) at 0, 4, 12, and 20 wks. PBO pts crossed over to GLM at wk24 except RA pts randomised to PBO who met early escape criteria crossed over at wk16 and AS pts randomised to PBO, who crossed-over at wk16. Data before crossover are presented. Infusion reactions, infections, serious infections, serious adverse events (SAEs), death, and antidrug antibodies (ADAs) were evaluated.

Results Overall, 740 and 539 pts were randomised to IV GLM and PBO groups, respectively. The% of IV GLM vs PBO pts reported the following across studies: infusion reactions (2.8 vs 0.2); SAEs (3.8 vs 2.4); infections (23.8 vs 17.3); serious infections (0.8 vs 0.4) and malignancies (0.1 vs 0.4). No deaths occurred in IV GLM group through wk24. Pts on IV GLM (n=574) vs PBO (n=391) w/concomitant MTX had similar proportions of serious infections (0.9 vs. 0.6). In IV GLM (n=349) vs PBO (n=224) pts who received CS, serious infections were 1.1% vs 0.9%; in pts who did not receive CS, serious infections were 0.5% vs 0%. In IV GLM pts w/normal ALT at baseline, 30% had postbaseline ALT elevation w/concomitant MTX vs 28% w/o. CS use had inconsistent effect on ALT elevations. Overall incidence of ADAs via drug tolerant assay was 20% (19% w/ MTX and 25% w/o MTX) through wk20 across RA, PsA and AS studies.

Conclusions IV GLM demonstrates the expected safety profile across RA, PSA and AS clinical trials in the PBO-controlled period. Differences between studies may be related to age, use of concomitant medications and disease indication.

Disclosure of Interest M. Husni: None declared, S. Schwartzman: None declared, A. Deodhar: None declared, S. Kafka Employee of: Janssen Scientific Affairs, LLC, S. Chakravarty: None declared, E. Hsia: None declared, D. Harrison: None declared, J. Leu: None declared, Y. Zhou: None declared, K. Lo: None declared, A. Kavanaugh: None declared

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