PMID- 37256582
OWN - NLM
STAT- MEDLINE
DCOM- 20230721
LR  - 20231031
IS  - 2168-6084 (Electronic)
IS  - 2168-6068 (Linking)
VI  - 159
IP  - 7
DP  - 2023 Jul 1
TI  - Biosimilars for the Treatment of Psoriasis: A Systematic Review of Clinical 
      Trials and Observational Studies.
PG  - 763-771
LID - 10.1001/jamadermatol.2023.1338 [doi]
AB  - IMPORTANCE: Biosimilars have the potential to reduce costs for the management of 
      moderate-to-severe psoriasis compared with originators. However, the 
      extrapolation of evidence enables the approval of a biosimilar for use in 
      indications held by the originator without directly being studied in clinical 
      trials. Thus, biosimilars can be approved for psoriasis based on extrapolated 
      evidence from other diseases. The availability of evidence for the effectiveness 
      and safety of biosimilars for the treatment of psoriasis is therefore unclear. 
      OBJECTIVE: To compare the efficacy/effectiveness and safety of biosimilars with 
      originator biologics for the treatment of patients with psoriasis. EVIDENCE 
      REVIEW: MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov, and The European 
      Union Clinical Trials Register were searched in August 2022. Eligible studies 
      were appraised using the Cochrane Risk of Bias 2 and ROBINS-I tools. All analyses 
      were conducted from September 2022 to November 2022. FINDINGS: Fourteen trials 
      (10 adalimumab, 2 etanercept, 1 infliximab, and 1 ustekinumab) and 3 cohort 
      studies (1 adalimumab, 1 etanercept, 1 infliximab and etanercept) were included. 
      Twelve trials compared biosimilars with originators in originator-naive patients 
      (starters), and 11 trials compared switching from originator to biosimilar 
      (switchers) with continuous originator treatments. There was no clinically or 
      statistically significant difference in rates of achieving 75% improvement in 
      Psoriasis Area and Severity Index scores and risks of adverse events (AEs) at 
      week 16 and week 52 between the comparators. Two cohort studies showed no 
      difference in effectiveness and safety outcomes between originators and 
      biosimilars, whereas 1 study reported more AEs in patients who switched to 
      biosimilars of adalimumab at 12 months. Three trials showed low risk of bias, 
      whereas 11 trials had moderate risk of bias. All cohort studies had moderate to 
      high risk of bias. CONCLUSIONS AND RELEVANCE: In this systematic review, there 
      was no clinically or statistically significant difference in the efficacy and 
      safety between biosimilars and originators for the treatment of patients with 
      psoriasis. Most of the available evidence was based on randomized clinical 
      trials, although high-quality real-world evidence was lacking. Future studies are 
      needed to examine the long-term effectiveness and safety of biosimilars for the 
      treatment of patients with psoriasis.
FAU - Phan, Duc Binh
AU  - Phan DB
AD  - Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The 
      University of Manchester, Manchester Academic Health Science Centre, NIHR 
      Manchester Biomedical Research Centre, Manchester, United Kingdom.
FAU - Elyoussfi, Sarah
AU  - Elyoussfi S
AD  - Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The 
      University of Manchester, Manchester Academic Health Science Centre, NIHR 
      Manchester Biomedical Research Centre, Manchester, United Kingdom.
FAU - Stevenson, Michael
AU  - Stevenson M
AD  - The University of Manchester Library, The University of Manchester, Manchester, 
      United Kingdom.
FAU - Lunt, Mark
AU  - Lunt M
AD  - Versus Arthritis Epidemiology Unit, The University of Manchester, Manchester, 
      United Kingdom.
FAU - Warren, Richard B
AU  - Warren RB
AD  - Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The 
      University of Manchester, Manchester Academic Health Science Centre, NIHR 
      Manchester Biomedical Research Centre, Manchester, United Kingdom.
FAU - Yiu, Zenas Z N
AU  - Yiu ZZN
AD  - Centre for Dermatology Research, Northern Care Alliance NHS Foundation Trust, The 
      University of Manchester, Manchester Academic Health Science Centre, NIHR 
      Manchester Biomedical Research Centre, Manchester, United Kingdom.
LA  - eng
GR  - NIHR203308/DH_/Department of Health/United Kingdom
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Systematic Review
PL  - United States
TA  - JAMA Dermatol
JT  - JAMA dermatology
JID - 101589530
RN  - OP401G7OJC (Etanercept)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - B72HH48FLU (Infliximab)
RN  - FYS6T7F842 (Adalimumab)
SB  - IM
CIN - JAMA Dermatol. 2023 Jul 1;159(7):697-699. PMID: 37256632
MH  - Humans
MH  - Etanercept/adverse effects
MH  - *Biosimilar Pharmaceuticals/adverse effects
MH  - Infliximab/adverse effects
MH  - Adalimumab/adverse effects
MH  - *Psoriasis/drug therapy/chemically induced
EDAT- 2023/05/31 13:12
MHDA- 2023/07/21 06:42
CRDT- 2023/05/31 11:33
PHST- 2023/07/21 06:42 [medline]
PHST- 2023/05/31 13:12 [pubmed]
PHST- 2023/05/31 11:33 [entrez]
AID - 2805555 [pii]
AID - 10.1001/jamadermatol.2023.1338 [doi]
PST - ppublish
SO  - JAMA Dermatol. 2023 Jul 1;159(7):763-771. doi: 10.1001/jamadermatol.2023.1338.