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Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis
Author(s) -
Leonardi C.,
Papp K.,
Strober B.,
Thaçi D.,
Warren R.B.,
Tyring S.,
Arikan D.,
Karunaratne M.,
Valdecantos W.C.
Publication year - 2019
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.17084
Subject(s) - adalimumab , medicine , psoriasis , plaque psoriasis , dermatology , clinical trial , term (time) , disease , physics , quantum mechanics
Summary Background Adalimumab (Humira ® , AbbVie Inc., North Chicago, IL , U.S.A.) is a fully human monoclonal antibody specific for tumour necrosis factor‐α that is approved to treat adults with moderate‐to‐severe chronic plaque psoriasis. Objectives To assess long‐term safety for patients with psoriasis receiving adalimumab in clinical studies. Methods Adalimumab safety data from adults with psoriasis who received at least one adalimumab dose in 18 clinical trials were evaluated. Adalimumab was delivered subcutaneously in all treatment regimens. Treatment‐emergent adverse events ( AE s) were collected from the first dose to 70 days after the last dose or cut‐off date (31 December 2015). AE incidence rates were expressed as events per 100 patient‐years (E/100 PY s) of adalimumab exposure. Standardized incidence ratios ( SIR s) for malignancies and standardized mortality ratios ( SMR s) were calculated. Results Cumulative exposure was 5429·7 PY s in 3727 patients. Overall, there were 16 536 AE s (304·6 E/100 PY s). The most common AE s were nasopharyngitis, upper respiratory infection and headache (23·7, 12·9 and 7·9 E/100 PY s, respectively). Incidence rates for serious infections, tuberculosis and opportunistic infections were 1·8, 0·3 and 0·02 E/100 PY s, respectively. Incidence of malignancy excluding nonmelanoma skin cancer ( NMSC ) was 0·8 E/100 PY s [ SIR 0·86, 95% confidence interval ( CI ) 0·58–1·23]. Incidences of NMSC and melanoma were 0·6 and 0·2 E/100 PY s, respectively. The SIR was 1·55 (95% CI 1·10–2·13) for NMSC and 3·04 (95% CI 1·11–6·62) for melanoma. The SMR was 0·34 (95% CI 0·16–0·65). Conclusions AE rates remained stable in this analysis of patients with psoriasis receiving adalimumab; no new safety signals were identified compared with earlier analyses.