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First-time adverse drug reactions, survival analysis, and the share of adverse drug reactions in treatment discontinuation in real-world rheumatoid arthritis patients: a comparison of first-time treatment with adalimumab and etanercept
被引:2
|作者:
Velthuis, Kimberly
[1
]
Jessurun, Naomi T.
[1
]
Nguyen, Thi D. M.
[1
]
Scholl, Joep
[1
]
Jansen, Jurriaan R. G.
[1
]
van Lint, Jette A.
[1
]
Kosse, Leanne J.
[1
,2
]
ten Klooster, Peter M.
[3
,4
]
Vonkeman, Harald E.
[4
,5
]
机构:
[1] Netherlands Pharmacovigilance Ctr Lareb, Shertogenbosch, Netherlands
[2] Radboud Univ Nijmegen, Radboud Inst Hlth Sci, Dept Pharm, Med Ctr, Nijmegen, Netherlands
[3] Transparency Healthcare BV, Hengelo, Netherlands
[4] Univ Twente, Dept Psychol Hlth & Technol, Enschede, Netherlands
[5] Med Spectrum Twente, Dept Rheumatol & Clin Immunol, Enschede, Netherlands
关键词:
Rheumatoid arthritis;
adverse drug reactions;
bDMARDs;
biologicals;
drug survival;
real-world data;
TRANSMEMBRANE TNF-ALPHA;
RETENTION RATES;
INFLIXIMAB;
AGENTS;
SURVEILLANCE;
DISEASE;
1ST;
D O I:
10.1080/14740338.2023.2172157
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
BackgroundThis study aims to compare nature and frequency of adverse drug reactions (ADRs), time to first ADR, drug survival, and the share of ADRs in treatment discontinuation of first-time treatment with adalimumab (ADA) and etanercept (ETN) in real-world RA patients.Research design and methods: Retrospective, single-center cohort study including naive patients treated between January 2003-April 2020. Time to first ADR and drug survival of first-time treatment were studied using Kaplan-Meier and Cox-regression models up to 10 years, with 2- and 5-year post-hoc sensitivity analysis. Nature and frequencies of first-time ADRs and causes of treatment discontinuation were assessed.ResultsIn total, 416 patients (ADA: 255, ETN: 161, 4865 patient years) were included, of which 92 (22.1%) experienced ADR(s) (ADA: 59, 23.1%; ETN: 33, 20.4%). Adjusted for age, gender and concomitant conventional DMARD use, ADA was more likely to be discontinued than ETN up to 2-, 5- and 10-year follow-up (adjusted HRs 1.63; 1.62; 1.59 (all p<0.001)). ADRs were the second reason of treatment discontinuation (ADA 20.7%, ETN 21.4%).ConclusionsDespite seemingly different nature and frequencies, ADRs are the second reason of treatment discontinuation for both bDMARDs. Furthermore, 2-, 5-, and 10-year drug survival is longer for ETN compared to ADA.
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页码:485 / 492
页数:8
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