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SAT0180 Two-year consolidated safety data for abp 501 in patients with moderate to severe rheumatoid arthritis

Annals of the rheumatic diseases, 2018-06, Vol.77 (Suppl 2), p.951 [Peer Reviewed Journal]

2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions ;Copyright: 2018 © 2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions ;ISSN: 0003-4967 ;EISSN: 1468-2060 ;DOI: 10.1136/annrheumdis-2018-eular.6746

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  • Title:
    SAT0180 Two-year consolidated safety data for abp 501 in patients with moderate to severe rheumatoid arthritis
  • Author: Krishnan, E. ; Zhang, N. ; Wang, H.
  • Subjects: Monoclonal antibodies ; Patients ; Rheumatoid arthritis ; Safety ; Stockholders
  • Is Part Of: Annals of the rheumatic diseases, 2018-06, Vol.77 (Suppl 2), p.951
  • Description: Background:Biosimilars are expected to have similar long-term safety profiles as originator products.Objectives:To describe the consolidated, 2-year safety data on ABP 501, an approved biosimilar to adalimumab.Methods:We combined individual patient data from a 26-week randomized controlled head-to-head study (parent study) comparing ABP 501 with adalimumab (NCT01970475) and its 72-week open-label extension (OLE) study (NCT02114931) in which all patients received only ABP 501. Safety data were reported by exposure-adjusted incidence rate as the number of subjects with the specified adverse events *(AEs) per 100 person-years. AEs from the parent and OLE studies were summarized; for each category, patients were included only once based on the 1st event in that AE category. All comparisons were performed descriptively.Results:In the parent study, 264 patients received ABP 501 and 262 patients received adalimumab reference product (RP). Of these, 229 in the ABP 501 arm and 237 in the RP arm entered and were treated in the open-label extension study. The exposure-adjusted incidence rate for treatment-emergent AEs by treatment group are shown in the Table.ABP 501/ABP 501(N = 264)Adalimumab RP/ABP 501(N = 262) Adverse Event CategoryExposure-adjusted incidence rate n/E (r)Any AE187/187.6 (99.7)197/192.2 (102.5)Any grade ≥3 AE32/405.2 (7.9)30/410.6 (7.3)Any treatment-related AE72/345.3 (20.9)79/344.3 (22.9)Any grade ≥3 treatment-related AE6/427.2 (1.4)5/433.6 (1.2)Any serious AE34/407.6 (8.3)32/410.1 (7.8)Any treatment-related serious AE6/427.9 (1.4)2/434.3 (0.5)Any events of interest141/261.5 (53.9)154/254.7 (60.5)Infections and infestations125/289.9 (43.1)130/287.4 (45.2)Liver enzyme elevations25/401.4 (6.2)20/415.6 (4.8)Hypersensitivity19/407.7 (4.7)22/412.2 (5.3)Injection site reactions6/417.9 (1.4)13/418.3 (3.1)Hematological reactions6/421.8 (1.4)7/426.1 (1.6)Malignancies6/423.9 (1.4)3/433.6 (0.7)Heart failure1/428.4 (0.2)2/435.6 (0.5)n = number of subjects with the specified AE; E = total subjects exposure-time (patient-years); r = exposure-adjusted incidence rate per 100 patient-years (100 * n/E).Conclusions:Over the 2-year observation period, there were no meaningful differences in AEs between adalimumab reference product and ABP 501.Disclosure of Interest:E. Krishnan Shareholder of: Amgen Inc., Employee of: Amgen Inc., N. Zhang Shareholder of: Amgen Inc., Employee of: Amgen Inc., H. Wang Shareholder of: Amgen Inc., Employee of: Amgen Inc.
  • Publisher: London: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 0003-4967
    EISSN: 1468-2060
    DOI: 10.1136/annrheumdis-2018-eular.6746
  • Source: ProQuest Central
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