PMID- 35859228
OWN - NLM
STAT- MEDLINE
DCOM- 20220913
LR  - 20221018
IS  - 1179-1969 (Electronic)
IS  - 1170-229X (Print)
IS  - 1170-229X (Linking)
VI  - 39
IP  - 9
DP  - 2022 Sep
TI  - Drug Survival, Safety, and Effectiveness of Biologics in Older Patients with 
      Psoriasis: A Comparison with Younger Patients-A BioCAPTURE Registry Study.
PG  - 715-727
LID - 10.1007/s40266-022-00961-y [doi]
AB  - BACKGROUND: Psoriasis is a common inflammatory disease in any age group, but also 
      in older patients (>/= 65 years of age). Since older patients are often excluded 
      from clinical trials, limited data specifically on this growing population are 
      available, e.g. regarding the safety and performance of biological treatment. 
      AIMS: We aimed to give insight into this specific population by comparing the 
      drug survival and safety of biologics in older patients with that in younger 
      patients. METHODS: In this real-world observational study, data from 3 academic 
      and 15 non-academic centers in The Netherlands were extracted from the 
      prospective BioCAPTURE registry. Biologics included in this study were tumor 
      necrosis factor (TNF)-alpha, interleukin (IL)-17, IL-12/23, and IL-23 inhibitors. 
      Patients were divided into two age groups: >/= 65 years and < 65 years. The 
      Charlson Comorbidity Index (CCI) was used to measure comorbid disease status, and 
      all adverse events (AEs) that led to treatment discontinuation were classified 
      according to the Medical Dictionary for Regulatory Activities (MedDRA) 
      classification. All AEs that led to treatment discontinuation were studied to 
      check whether they could be classified as serious AEs (SAEs). Kaplan-Meier 
      survival curves for overall 5-year drug survival and split according to reasons 
      of discontinuation (ineffectiveness or AEs) were constructed. Cox regression 
      models were used to correct for possible confounders and to investigate 
      associations with drug survival in both age groups separately. Psoriasis Area and 
      Severity Index (PASI) scores during the first 2 years of treatment and at the 
      time of treatment discontinuation were assessed and compared between age groups. 
      RESULTS: A total of 890 patients were included, of whom 102 (11.4%) were aged 
      >/= 65 years. Body mass index, sex, and distribution of biologic classes (e.g. 
      TNFalpha, IL12/23) were not significantly different between the two age groups. A 
      significantly higher CCI score was found in older patients, indicative of more 
      comorbidity (p < 0.001). The 5-year ineffectiveness-related drug survival was 
      lower for older patients (44.5% vs. 60.5%; p = 0.006), and the 5-year overall 
      (>/= 65 years: 32.4% vs. < 65 years: 42.1%; p = 0.144) and AE-related (>/= 65 years: 
      82.1% vs. < 65 years: 79.5%; p = 0.913) drug survival was comparable between age 
      groups. Of all AEs (n = 155) that led to discontinuation, 16 (10.3%) were 
      reported as SAEs but these only occurred in younger patients. After correcting 
      for confounders, the same trends were observed in the drug survival outcomes. 
      Linear regression analyses on PASI scores showed no statistical differences at 6, 
      12, 18, and 24 months of treatment between age groups. CONCLUSIONS: This study in 
      a substantial, well-defined, prospective cohort provides further support that the 
      use of biologics in older patients seems well-tolerated and effective. Biologic 
      discontinuation due to AEs did not occur more frequently in older patients. Older 
      patients discontinued biologic treatment more often due to ineffectiveness, 
      although no clear difference in PASI scores was observed. More real-world studies 
      on physician- and patient-related factors in older patients are warranted.
CI  - (c) 2022. The Author(s).
FAU - Ter Haar, E L M
AU  - Ter Haar ELM
AUID- ORCID: 0000-0001-9874-4670
AD  - Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 
      9101, 6500 HB, Nijmegen, The Netherlands. Elke.terHaar@radboudumc.nl.
AD  - Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre 
      (Radboudumc), Nijmegen, The Netherlands. Elke.terHaar@radboudumc.nl.
FAU - Thomas, S E
AU  - Thomas SE
AUID- ORCID: 0000-0002-1343-353X
AD  - Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 
      9101, 6500 HB, Nijmegen, The Netherlands.
AD  - Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre 
      (Radboudumc), Nijmegen, The Netherlands.
FAU - van den Reek, J M P A
AU  - van den Reek JMPA
AUID- ORCID: 0000-0002-3642-2673
AD  - Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 
      9101, 6500 HB, Nijmegen, The Netherlands.
AD  - Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre 
      (Radboudumc), Nijmegen, The Netherlands.
FAU - Otero, M E
AU  - Otero ME
AUID- ORCID: 0000-0003-0191-3293
AD  - Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 
      9101, 6500 HB, Nijmegen, The Netherlands.
AD  - Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre 
      (Radboudumc), Nijmegen, The Netherlands.
FAU - Njoo, M D
AU  - Njoo MD
AUID- ORCID: 0000-0003-1424-5722
AD  - Department of Dermatology, Ziekenhuisgroep Twente, Almelo/Hengelo, The 
      Netherlands.
FAU - Ossenkoppele, P M
AU  - Ossenkoppele PM
AUID- ORCID: 0000-0002-7311-7213
AD  - Department of Dermatology, Ziekenhuisgroep Twente, Almelo/Hengelo, The 
      Netherlands.
FAU - Kop, E N
AU  - Kop EN
AD  - Department of Dermatology, Bernhoven Ziekenhuis, Uden, The Netherlands.
FAU - Dodemont, S R P
AU  - Dodemont SRP
AUID- ORCID: 0000-0001-5395-5925
AD  - Department of Dermatology, Catharina Ziekenhuis, Eindhoven, The Netherlands.
FAU - Korver, J E M
AU  - Korver JEM
AD  - Department of Dermatology, Amphia Ziekenhuis, Breda, The Netherlands.
FAU - Kuijpers, A L A
AU  - Kuijpers ALA
AUID- ORCID: 0000-0001-7874-1165
AD  - Department of Dermatology, Maxima Medisch Centrum, Eindhoven, The Netherlands.
FAU - Lindhout, R J
AU  - Lindhout RJ
AD  - Department of Dermatology, Jeroen Bosch Ziekenhuis, 's Hertogenbosch, The 
      Netherlands.
FAU - Tupker, R A
AU  - Tupker RA
AUID- ORCID: 0000-0003-2378-3741
AD  - Department of Dermatology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands.
FAU - Mommers, J M
AU  - Mommers JM
AUID- ORCID: 0000-0002-4930-4107
AD  - Department of Dermatology, Anna Ziekenhuis, Geldrop, The Netherlands.
FAU - Berends, M A M
AU  - Berends MAM
AUID- ORCID: 0000-0003-3851-1407
AD  - Department of Dermatology, Slingeland Ziekenhuis, Doetinchem, The Netherlands.
FAU - Koetsier, M I A
AU  - Koetsier MIA
AUID- ORCID: 0000-0002-7823-8380
AD  - Department of Dermatology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands.
FAU - de Bruin-Weller, M S
AU  - de Bruin-Weller MS
AUID- ORCID: 0000-0002-1249-6993
AD  - Department of Dermatology, Utrecht Medisch Centrum, Utrecht, The Netherlands.
FAU - Visch, M B
AU  - Visch MB
AUID- ORCID: 0000-0001-6265-3830
AD  - Department of Dermatology, Ziekenhuis Rijnstate, Arnhem, The Netherlands.
FAU - Arnold, W P
AU  - Arnold WP
AUID- ORCID: 0000-0002-7267-7825
AD  - Department of Dermatology, Ziekenhuis Gelderse Vallei, Ede, The Netherlands.
FAU - van Lumig, P P M
AU  - van Lumig PPM
AUID- ORCID: 0000-0001-6619-0853
AD  - Department of Dermatology, Maastricht University Medical Centre, Maastricht, The 
      Netherlands.
FAU - Kleinpenning, M M
AU  - Kleinpenning MM
AD  - Department of Dermatology, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The 
      Netherlands.
FAU - Lubeek, S F K
AU  - Lubeek SFK
AUID- ORCID: 0000-0003-2694-6059
AD  - Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 
      9101, 6500 HB, Nijmegen, The Netherlands.
AD  - Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre 
      (Radboudumc), Nijmegen, The Netherlands.
FAU - de Jong, E M G J
AU  - de Jong EMGJ
AUID- ORCID: 0000-0003-3872-5704
AD  - Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 
      9101, 6500 HB, Nijmegen, The Netherlands.
AD  - Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre 
      (Radboudumc), Nijmegen, The Netherlands.
AD  - Radboud University, Nijmegen, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20220721
PL  - New Zealand
TA  - Drugs Aging
JT  - Drugs & aging
JID - 9102074
RN  - 0 (Biological Products)
SB  - IM
MH  - Aged
MH  - *Biological Products/therapeutic use
MH  - Humans
MH  - Prospective Studies
MH  - *Psoriasis/drug therapy
MH  - Registries
MH  - Treatment Outcome
PMC - PMC9300332
COIS- E.L.M. ter Haar has carried out investigator-initiated research with financial 
      support from Almirall and has carried out clinical trials for Novartis. All 
      funding is not personal but goes to the independent research fund of the 
      Department of Dermatology, Radboud University Medical Center Nijmegen 
      (Radboudumc), The Netherlands. S.E. Thomas carries out clinical trials for 
      Janssen and Novartis. All funding is not personal but goes to the independent 
      research fund of the Department of Dermatology, Radboud University Medical Center 
      Nijmegen, The Netherlands. M.E. Otero has acted as a consultant for Eli Lilly. 
      P.P.M. van Lumig has received research funding from Wyeth; has carried out 
      clinical trials for Abbott and Janssen-Cilag; has received speaking and 
      consulting fees from Wyeth and Schering-Plough; has received reimbursement for 
      attending a symposium from Schering-Plough and Pfizer; and has attended advisory 
      boards for Abbvie, Leo Pharma, Novartis and UCB. W.P. Arnold has been a 
      consultant, advisory board member, and/or speaker for AbbVie and UCB. S.R.P. 
      Dodemont has attended advisory boards for Abbvie, Janssen and Leo Pharma, and has 
      received a congress fee from Abbvie. M.S. de Bruin-Weller has been a consultant, 
      advisory board member, and/or speaker for AbbVie, Almirall, Arena, Aslan, Eli 
      Lilly, Galderma, Janssen, Leo Pharma, Pfizer, Regeneron, and Sanofi-Genzyme. R.A. 
      Tupker has attended advisory boards for Leo Pharma, UCB Pharma, and Eli Lilly 
      Netherlands. E.M.G.J. de Jong has received research grants for the independent 
      research fund of the Department of Dermatology, Radboud University Medical Center 
      Nijmegen, The Netherlands, from AbbVie, BMS, Janssen Pharmaceutica, Leo Pharma, 
      Novartis, and UCB for research on psoriasis; has acted as a consultant and/or 
      paid speaker for, and/or participated in research sponsored by, companies that 
      manufacture drugs used for the treatment of psoriasis or eczema, including 
      AbbVie, Amgen, Almirall, Celgene, Galapagos, Janssen Pharmaceutica, Lilly, 
      Novartis, Leo Pharma, Sanofi and UCB. All funding is not personal but goes to the 
      independent research fund of the Department of Dermatology, Radboud University 
      Medical Center Nijmegen, The Netherlands. J.M.P.A. van den Reek has carried out 
      clinical trials for AbbVie, Celgene and Janssen; has received speaking 
      fees/attended advisory boards from AbbVie, Janssen, BMS, Almirall, LEO Pharma, 
      and Eli Lilly; and has received reimbursement for attending a symposium from 
      Janssen, Pfizer, Celgene, and AbbVie. All funding is not personal but goes to the 
      independent research fund of the Department of Dermatology, Radboud University 
      Medical Center Nijmegen, The Netherlands. S.F.K. Lubeek has received research 
      grants for investigator-initiated research by Almirall, and has acted as a 
      consultant and/or paid speaker for Janssen, LEO Pharma, Almirall, Sanofi Genzyme, 
      and Sunpharma. All funding is not personal but goes to the independent research 
      fund of the Department of Dermatology, Radboud University Medical Centre 
      Nijmegen, The Netherlands. M.D. Njoo, P.M. Ossenkoppele, E.N. Kop, J.E.M. Korver, 
      A.L.A. Kuijpers, R.J. Lindhout, J.M. Mommers, M.A.M. Berends, M.I.A. Koetsier, 
      M.B. Visch, and M.M. Kleinpenning have no conflicts of interest to report.
EDAT- 2022/07/22 06:00
MHDA- 2022/09/14 06:00
PMCR- 2022/07/21
CRDT- 2022/07/21 00:02
PHST- 2022/06/08 00:00 [accepted]
PHST- 2022/07/22 06:00 [pubmed]
PHST- 2022/09/14 06:00 [medline]
PHST- 2022/07/21 00:02 [entrez]
PHST- 2022/07/21 00:00 [pmc-release]
AID - 10.1007/s40266-022-00961-y [pii]
AID - 961 [pii]
AID - 10.1007/s40266-022-00961-y [doi]
PST - ppublish
SO  - Drugs Aging. 2022 Sep;39(9):715-727. doi: 10.1007/s40266-022-00961-y. Epub 2022 
      Jul 21.