PMID- 32885846
OWN - NLM
STAT- MEDLINE
DCOM- 20211027
LR  - 20211027
IS  - 1440-0960 (Electronic)
IS  - 0004-8380 (Linking)
VI  - 62
IP  - 1
DP  - 2021 Feb
TI  - Treatment modalities and risk of adverse events associated with biologic therapy: 
      A 10-year observational review of the Australasian Psoriasis Registry.
PG  - e47-e54
LID - 10.1111/ajd.13450 [doi]
AB  - BACKGROUND: Psoriasis is a chronic inflammatory disease affecting ~2-3% of the 
      Australasian population. Therapeutic options include topical agents, 
      phototherapy, systemic immunomodulators and biologic agents. Biologics present an 
      acceptable short- and medium-term safety profile, derived mainly from randomised 
      controlled trials (RCTs) and, however, may not represent real-world rates of 
      adverse events (AEs). METHODS: A retrospective, observational study of patients 
      enrolled in The Australasian Psoriasis Registry from April 2008 to October 2018 
      was conducted. Data were collected from 104 sites in Australia and New Zealand. 
      Patient characteristics, treatments and AE data were collected. AEs were 
      classified by MedDRA System events. RESULTS: 2094 patients were included (3765 
      patient-treatments), comprising; 1110 phototherapy, 1280 systemic and 1375 
      biologic therapy patient-treatments. Treatment arms were not mutually exclusive. 
      The mean +/- SD from date of diagnosis of psoriasis to commencement of biologic 
      therapy was 8.9 +/- 12.3 years. Methotrexate had the longest exposure time (3740.3 
      patient-years), and ustekinumab had the longest median (95% CI) time on 
      treatment, 4.3 years (2.2, 6.6). AE differences on biologic treatment were 
      present between patients who would have been eligible or ineligible for RCTs. 
      Approximately 29% of registry patients would have been excluded from clinical 
      trials enrolment. Patients ineligible for RCTs had increased adjusted hazard 
      ratios (95% CI) of: infections and infestations (2.3, 1.7-3.1; P < 0.001), 
      cardiac (8.2, 3.5-25.6; P < 0.001), gastrointestinal (3.5, 1.52-8.0; P < 0.001), 
      hepatobiliary (5.6 1.7-19.1; P < 0.001), psychiatric (4.7, 1.5-14.1; P = 0.006) 
      and eye disorders (4.8 1.5-15.6; P = 0.008), compared to those eligible for RCTs. 
      Incidence rates in the trial eligible patients were similar to those reported 
      from RCT rates. CONCLUSIONS: This study establishes treatment modalities in use 
      for severe psoriasis and the clinical rates of AEs associated with biologic 
      therapy.
CI  - (c) 2020 The Australasian College of Dermatologists.
FAU - Doolan, Brent J
AU  - Doolan BJ
AUID- ORCID: 0000-0002-9497-0504
AD  - Department of Dermatology, The Royal Melbourne Hospital, Melbourne, Victoria, 
      Australia.
AD  - Skin Health Institute, Carlton, Victoria, Australia.
AD  - The Skin Hospital, Sydney, New South Wales, Australia.
FAU - Koye, Digsu
AU  - Koye D
AD  - The Melbourne EpiCentre, University of Melbourne and Melbourne Health, Melbourne, 
      Victoria, Australia.
FAU - Ling, Joanna
AU  - Ling J
AD  - The Melbourne EpiCentre, University of Melbourne and Melbourne Health, Melbourne, 
      Victoria, Australia.
FAU - Cains, Geoffrey D
AU  - Cains GD
AD  - Department of Dermatology, Liverpool Hospital, Sydney, New South Wales, 
      Australia.
AD  - School of Medicine, University of New South Wales, Sydney, New South Wales, 
      Australia.
FAU - Baker, Christopher
AU  - Baker C
AD  - Skin Health Institute, Carlton, Victoria, Australia.
AD  - Department of Dermatology and Medicine, St Vincent's Hospital, Melbourne, The 
      University of Melbourne, Fitzroy, Victoria, Australia.
FAU - Foley, Peter
AU  - Foley P
AD  - Skin Health Institute, Carlton, Victoria, Australia.
AD  - Department of Dermatology and Medicine, St Vincent's Hospital, Melbourne, The 
      University of Melbourne, Fitzroy, Victoria, Australia.
FAU - Dolianitis, Con
AU  - Dolianitis C
AD  - Department of Dermatology, The Royal Melbourne Hospital, Melbourne, Victoria, 
      Australia.
AD  - Department of Medicine, The University of Melbourne, Melbourne, Victoria, 
      Australia.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20200904
PL  - Australia
TA  - Australas J Dermatol
JT  - The Australasian journal of dermatology
JID - 0135232
RN  - 0 (Dermatologic Agents)
RN  - FU77B4U5Z0 (Ustekinumab)
RN  - FYS6T7F842 (Adalimumab)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adalimumab/administration & dosage/adverse effects
MH  - Australia/epidemiology
MH  - Dermatologic Agents/administration & dosage/*adverse effects
MH  - Female
MH  - Humans
MH  - Male
MH  - Methotrexate/administration & dosage/adverse effects
MH  - Middle Aged
MH  - New Zealand/epidemiology
MH  - Phototherapy
MH  - Psoriasis/epidemiology/*therapy
MH  - Registries
MH  - Retrospective Studies
MH  - Ustekinumab/administration & dosage/adverse effects
OTO - NOTNLM
OT  - Australia
OT  - adverse events
OT  - biologic therapy
OT  - phototherapy
OT  - psoriasis
OT  - systemic therapy
OT  - treatment
EDAT- 2020/09/05 06:00
MHDA- 2021/10/28 06:00
CRDT- 2020/09/05 06:00
PHST- 2020/07/06 00:00 [received]
PHST- 2020/08/02 00:00 [accepted]
PHST- 2020/09/05 06:00 [pubmed]
PHST- 2021/10/28 06:00 [medline]
PHST- 2020/09/05 06:00 [entrez]
AID - 10.1111/ajd.13450 [doi]
PST - ppublish
SO  - Australas J Dermatol. 2021 Feb;62(1):e47-e54. doi: 10.1111/ajd.13450. Epub 2020 
      Sep 4.