Drug Survival, Safety, and Effectiveness of Biologics in Older Patients with Psoriasis: A Comparison with Younger Patients-A BioCAPTURE Registry Study.

Autor: Ter Haar ELM; Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 9101, 6500 HB, Nijmegen, The Netherlands. Elke.terHaar@radboudumc.nl.; Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands. Elke.terHaar@radboudumc.nl., Thomas SE; Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 9101, 6500 HB, Nijmegen, The Netherlands.; Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands., van den Reek JMPA; Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 9101, 6500 HB, Nijmegen, The Netherlands.; Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands., Otero ME; Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 9101, 6500 HB, Nijmegen, The Netherlands.; Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands., Njoo MD; Department of Dermatology, Ziekenhuisgroep Twente, Almelo/Hengelo, The Netherlands., Ossenkoppele PM; Department of Dermatology, Ziekenhuisgroep Twente, Almelo/Hengelo, The Netherlands., Kop EN; Department of Dermatology, Bernhoven Ziekenhuis, Uden, The Netherlands., Dodemont SRP; Department of Dermatology, Catharina Ziekenhuis, Eindhoven, The Netherlands., Körver JEM; Department of Dermatology, Amphia Ziekenhuis, Breda, The Netherlands., Kuijpers ALA; Department of Dermatology, Máxima Medisch Centrum, Eindhoven, The Netherlands., Lindhout RJ; Department of Dermatology, Jeroen Bosch Ziekenhuis, 's Hertogenbosch, The Netherlands., Tupker RA; Department of Dermatology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands., Mommers JM; Department of Dermatology, Anna Ziekenhuis, Geldrop, The Netherlands., Berends MAM; Department of Dermatology, Slingeland Ziekenhuis, Doetinchem, The Netherlands., Koetsier MIA; Department of Dermatology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands., de Bruin-Weller MS; Department of Dermatology, Utrecht Medisch Centrum, Utrecht, The Netherlands., Visch MB; Department of Dermatology, Ziekenhuis Rijnstate, Arnhem, The Netherlands., Arnold WP; Department of Dermatology, Ziekenhuis Gelderse Vallei, Ede, The Netherlands., van Lümig PPM; Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands., Kleinpenning MM; Department of Dermatology, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands., Lubeek SFK; Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 9101, 6500 HB, Nijmegen, The Netherlands.; Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands., de Jong EMGJ; Department of Dermatology, Radboud University Medical Centre (Radboudumc), PO Box 9101, 6500 HB, Nijmegen, The Netherlands.; Radboud Institute for Health Sciences (RIHS), Radboud University Medical Centre (Radboudumc), Nijmegen, The Netherlands.; Radboud University, Nijmegen, The Netherlands.
Jazyk: angličtina
Zdroj: Drugs & aging [Drugs Aging] 2022 Sep; Vol. 39 (9), pp. 715-727. Date of Electronic Publication: 2022 Jul 21.
DOI: 10.1007/s40266-022-00961-y
Abstrakt: 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)-α, 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. TNFα, 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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