PMID- 30169904
OWN - NLM
STAT- MEDLINE
DCOM- 20191120
LR  - 20191120
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 180
IP  - 1
DP  - 2019 Jan
TI  - Comprehensive long-term safety of adalimumab from 18 clinical trials in adult 
      patients with moderate-to-severe plaque psoriasis.
PG  - 76-85
LID - 10.1111/bjd.17084 [doi]
AB  - BACKGROUND: Adalimumab (Humira((R)) , AbbVie Inc., North Chicago, IL, U.S.A.) is a 
      fully human monoclonal antibody specific for tumour necrosis factor-alpha 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 (AEs) 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 PYs) of adalimumab 
      exposure. Standardized incidence ratios (SIRs) for malignancies and standardized 
      mortality ratios (SMRs) were calculated. RESULTS: Cumulative exposure was 5429.7 
      PYs in 3727 patients. Overall, there were 16 536 AEs (304.6 E/100 PYs). The most 
      common AEs were nasopharyngitis, upper respiratory infection and headache (23.7, 
      12.9 and 7.9 E/100 PYs, respectively). Incidence rates for serious infections, 
      tuberculosis and opportunistic infections were 1.8, 0.3 and 0.02 E/100 PYs, 
      respectively. Incidence of malignancy excluding nonmelanoma skin cancer (NMSC) 
      was 0.8 E/100 PYs [SIR 0.86, 95% confidence interval (CI) 0.58-1.23]. Incidences 
      of NMSC and melanoma were 0.6 and 0.2 E/100 PYs, 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.
CI  - (c) 2018 British Association of Dermatologists.
FAU - Leonardi, C
AU  - Leonardi C
AD  - Department of Dermatology, St. Louis University, St. Louis, MO, U.S.A.
FAU - Papp, K
AU  - Papp K
AUID- ORCID: 0000-0001-9557-3642
AD  - Probity Medical Research and K. Papp Clinical Research, Waterloo, ON, Canada.
FAU - Strober, B
AU  - Strober B
AUID- ORCID: 0000-0002-8394-2057
AD  - Department of Dermatology and Probity Medical Research, University of 
      Connecticut, Farmington, CT, U.S.A.
FAU - Thaci, D
AU  - Thaci D
AD  - Comprehensive Center for Inflammation Medicine, University of Lubeck, Lubeck, 
      Germany.
FAU - Warren, R B
AU  - Warren RB
AD  - Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester 
      Biomedical Research Centre, The University of Manchester, Manchester Academic 
      Health Science Centre, Manchester, M13 9PT, U.K.
FAU - Tyring, S
AU  - Tyring S
AD  - Department of Dermatology, University of Texas Health Science Center at Houston, 
      Houston, TX, U.S.A.
FAU - Arikan, D
AU  - Arikan D
AD  - AbbVie Inc., North Chicago, IL, U.S.A.
FAU - Karunaratne, M
AU  - Karunaratne M
AD  - AbbVie Inc., North Chicago, IL, U.S.A.
FAU - Valdecantos, W C
AU  - Valdecantos WC
AD  - AbbVie Inc., North Chicago, IL, U.S.A.
LA  - eng
PT  - Journal Article
DEP - 20181010
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (TNF protein, human)
RN  - 0 (Tumor Necrosis Factor-alpha)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
CIN - Br J Dermatol. 2019 Jan;180(1):14-15. PMID: 30604539
MH  - Adalimumab/administration & dosage/*adverse effects
MH  - Adult
MH  - Anti-Inflammatory Agents/administration & dosage/*adverse effects
MH  - Clinical Trials as Topic
MH  - Datasets as Topic
MH  - Female
MH  - Headache/chemically induced/epidemiology
MH  - Humans
MH  - Incidence
MH  - Injections, Subcutaneous
MH  - *Long-Term Care
MH  - Male
MH  - Middle Aged
MH  - Nasopharyngitis/chemically induced/epidemiology
MH  - Neoplasms/chemically induced/epidemiology
MH  - Opportunistic Infections/chemically induced/epidemiology
MH  - Psoriasis/diagnosis/*drug therapy/immunology
MH  - Severity of Illness Index
MH  - Time Factors
MH  - Tuberculosis/chemically induced/epidemiology
MH  - Tumor Necrosis Factor-alpha/antagonists & inhibitors/immunology
EDAT- 2018/09/01 06:00
MHDA- 2019/11/21 06:00
CRDT- 2018/09/01 06:00
PHST- 2018/08/01 00:00 [accepted]
PHST- 2018/09/01 06:00 [pubmed]
PHST- 2019/11/21 06:00 [medline]
PHST- 2018/09/01 06:00 [entrez]
AID - 10.1111/bjd.17084 [doi]
PST - ppublish
SO  - Br J Dermatol. 2019 Jan;180(1):76-85. doi: 10.1111/bjd.17084. Epub 2018 Oct 10.