Safety Assessment of Conventional and Biological Systemic Therapy in Older Adults with Psoriasis, a Real-world Multicentre Cohort Study

Abstract

Optimal selection of systemic therapy in older adults with psoriasis can be challenging, due to sparse evidence-based guidance. This multicentre retrospective study investigated the safety of systemic therapy with causality assessment in a real-world cohort of older adults (≥ 65 years) with psoriasis. Data from 6 hospitals on (severe) adverse events were collected, causality assessment performed and incidence rate ratios calculated. Potential predictors for adverse events-occurrence were studied using multivariable logistic regression analysis. In total, 117 patients with 176 treatment episodes and 390 patient-years were included, comprising 115 (65.3%) and 61 (34.7%) treatment episodes with conventional systemic therapy and biologics/apremilast, respectively. After causality assessment, 232 of 319 (72.7%) adverse events remained and were analysed further, including 12 severe adverse events. No significant differences in incidence rate ratios were found between the systemic treatment types. In regression analysis, increasing age was associated with causality assessed adverse events-occurrence (odds ratio 1.195; p=0.022). Comorbidity, polypharmacy, and treatment type were not associated with causality assessed adverse events-occurrence. In conclusion, increasing age was associated with a higher causality assessed adverse events-occurrence. Causality assessed severe adverse events were rare, reversible and/or manageable in clinical practice. In conclusion, the safety profile of systemic antipsoriatic therapy within this population is reassuring.

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

“…In terms of infection, both age groups showed a similar profile, sharing the highest incidence of nasopharyngitis and other respiratory tract infection, in line with those of phase II–III trials with biologics ( 38 , 39 ) and available real-world evidence (RWE) registries ( 40 ), with no new safety evidence. However, in terms of TEAEs of special interest, older patients showed proportionally more cases of cardiovascular events, NMSC and other malignancies compared with younger patients, as previously described in the literature ( 13 ), most likely related to the ageing process and the longer psoriatic disease duration, and not due to the psoriatic treatment administered. In general, these results demonstrate the potential benefit of TIL in older patients without affecting their safety profile.…”

“…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 ).…”

Exclusion by age, cardiovascular comorbidity and malignancies are the main factors that impact generalizability of evidence from trials to the real‐world situation in older adults with psoriasis

“…The study setup was previously described. 5 To compare the comorbid disease status of study participants to the general Dutch population, standardized prevalence ratios (SPR) were calculated: the number of observed cases was divided by expected cases based on general population data sources (Table 1), stratified for age. To determine the impact of RCT exclusion criteria on this cohort of older adults with psoriasis, an 'impact statistic' (ranging from 0 to 100) was calculated by multiplying the occurrence of exclusion criteria of RCTs with the actual comorbidity prevalence in this cohort, divided by 100.…”