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Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries
Author(s) -
Strober B.,
Crowley J.,
Langley R.G.,
Gordon K.,
Menter A.,
Leonardi C.,
Arikan D.,
Valdecantos W.C.
Publication year - 2018
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.15203
Subject(s) - medicine , adalimumab , psoriasis , adverse effect , incidence (geometry) , medline , dermatology , disease , physics , political science , law , optics
Long‐term safety of adalimumab in psoriasis clinical studies has been established. The objective of this research was to review real‐world evidence of adalimumab safety from registries of adult patients with psoriasis treated in clinical practice. Databases ( BIOSIS Previews, Current Contents Search, Derwent Drug File, EMBASE , EMBASE Alert, EMC are, MEDLINE , SciSearch) were searched for psoriasis registries with adalimumab safety data. Eligible papers were English language manuscripts (conference abstracts excluded) from psoriasis registries presenting safety data for adult patients with psoriasis receiving adalimumab. The incidence and rate (events/100 patient‐years [ PY ]) of adverse events ( AE s), serious AE s ( SAE s) and AE s of special interest are reported. Abstracts of 425 publications were screened, and 401 publications excluded (208 conference abstracts; 193 papers). Remaining manuscripts were fully screened; 14 were excluded (no adalimumab data, n = 10; no safety data, n = 2; no on‐treatment data, n = 1; not English, n = 1), and 10 selected. Overall rates of AE s (4273 [22.2/100 PY ]) and SAE s (827 [4.3/100 PY ]) were reported in the ESPRIT registry ( N = 6059). Rates of infections (7.7–14.7/100 PY ) and serious infections (<0.6–2.0/100 PY ) were reported in four studies. Cardiovascular‐related events were reported in three studies: ≤0.1/100 PY per major cardiac event in ESPRIT , <0.5/100 PY major cardiac events in PsoBest and serious cardiovascular events in two patients (<1%) in DERMBIO . Malignancies were reported in three studies (any malignancy, 0.9/100 PY ; malignancies excluding non‐melanoma skin cancer [ NMSC ], <0.6/100 PY ; NMSC , 0.6–<0.5/100 PY ). These findings suggest that real‐world safety of adalimumab is consistent across different psoriasis registries, which supports the existing long‐term safety profile of adalimumab from clinical studies.