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

Abstract

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 ineffectivenessrelated 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 dif...

Therapy of PsO in Special Subsets of Patients

“…They include etanercept, adalimumab, infliximab, and certolizumab pegol either as originator or biosimilar drugs, when available. Generally, a similar efficacy in elderly patients undergoing anti-TNF has been reported so far when compared with younger patients [ 55 , 56 , 57 , 58 , 59 ], but a few studies show a lower response rate in elderly patients that were treated for other diseases than psoriasis [ 60 ]. A previous retrospective study positively evaluated the long-term efficacy and safety profile of etanercept and adalimumab in the treatment of elderly patients affected by plaque-type psoriasis and psoriatic arthritis [ 61 ].…”

“…Biologic therapies have become the key drugs in the treatment of moderate-to-severe psoriasis in terms of short- and long-term efficacy and safety. A huge amount of data from clinical trials, post-marketing, and real word experience have been collected; however, their use has not been sufficiently investigated in elderly patients [ 21 , 22 , 23 , 54 , 55 , 56 , 57 ].…”

Comparative Treatment Persistence and Adherence to Endothelin Receptor Antagonists Among Patients with Pulmonary Arterial Hypertension in Japan: A Real-World Administrative Claims Database Study

“…An event was defined as treatment discontinuation or death, with two primary reasons for discontinuation assumed to be adverse events (AEs) and lack of efficacy. The concept of drug persistence (i.e., drug survival) originated from studies evaluating biologics for the treatment of immune-mediated inflammatory diseases (e.g., psoriasis), where drug persistence/survival is frequently a prespecified clinical outcome [24][25][26][27][28][29][30][31]. In the current study, as in many others [24][25][26][27][28][29][30][31], drug persistence includes both treatment discontinuation and death because they both effectively result in the same outcome, end of treatment persistence.…”

“…The concept of drug persistence (i.e., drug survival) originated from studies evaluating biologics for the treatment of immune-mediated inflammatory diseases (e.g., psoriasis), where drug persistence/survival is frequently a prespecified clinical outcome [24][25][26][27][28][29][30][31]. In the current study, as in many others [24][25][26][27][28][29][30][31], drug persistence includes both treatment discontinuation and death because they both effectively result in the same outcome, end of treatment persistence. Furthermore, the MDV database does not capture all deaths, only those within the same DPC hospital, thus precluding the ability to analyze survival separately.…”

Efficacy and Safety of Tildrakizumab in Older Patients: Pooled Analyses of Two Randomized Phase III Clinical Trials (reSURFACE 1 and reSURFACE 2) Through 244 Weeks

“…comorbidities) ( 11 ), and representation of older patients in the available trial literature is low. However, a recent registry reported that discontinuation of biologics due to AEs did not occur more frequently in older compared with younger patients ( 12 ). Older patients tended to have more serious infections, non-melanoma skin cancer (NMSC) and malignancies than younger patients, possibly due to the ageing process and more extensive duration of disease ( 9 , 13 ).…”