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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
Journal article   Open access   Peer reviewed

FRI0128 Integrated safety data analysis across phase 3 clinical studies for intravenous golimumab in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

M.E Husni, S Schwartzman, A Deodhar, S Kafka, S.D Chakravarty, E.C Hsia, D.D Harrison, J.H Leu, Y Zhou, K.H Lo, …
Annals of the rheumatic diseases, v 77(Suppl 2), p608
Jun 2018
DOI: https://doi.org/10.1136/annrheumdis-2018-eular.5425
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https://doi.org/10.1136/annrheumdis-2018-eular.5425View
Published, Version of Record (VoR)Maybe Open Access (Publisher Bronze),  Open

Abstract

BackgroundIntravenous golimumab (IV GLM) is approved for treatment of adults w/rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).ObjectivesTo 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.MethodsIntegrated 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.ResultsOverall, 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.RAPsAASALL IV GLMPBOIV GLMPBOIV GLMPBOIV GLMPBO Treated Pts395197240239105103740539Age in years, Mean (Range)51.9(18–8351.4(19–7845.7(19–6946.7(18–7938.4(19–6439.2(20–67Disease Duration in Years, Mean (SD)6.9 (7.00)7.0 (7.24)6.2 (6.03)5.3 (5.92)5.6 (6.57)5.5 (5.93)Avg duration of follow-up (wks)23.620.923.923.216.116.022.621.0Pts w/≥1 infusion reaction,n (%)14 (3.5)1 (0.5)4 (1.7)03 (2.9)021 (2.8)1 (0.2)Pts w/≥1 SAE,n (%)19 (4.8)5 (2.5)7 (2.9)8 (3.3)2 (1.9)028 (3.8)13 (2.4)Pts w/≥1 infection, n (%)119 (30.1)48 (24.4)45 (18.8)37 (15.5)12 (11.4)8 (7.8)176 (23.8)93 (17.3)Pts w/≥1 serious infection, n (%)4 (1.0)01 (0.4)2 (0.8)1 (1.0)06 (0.8)2 (0.4)Pts w/≥1 malignancy, n (%)1 (0.3)002 (0.8)001 (0.1)2 (0.4)Deaths, n (%)01 (0.5)02 (0.8)0003 (0.6)% ADA positive*21201920*w/drug tolerant assayConclusionsIV 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 InterestM. 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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Rheumatology
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