Effectiveness and safety of anti‐IL‐23 and anti‐IL‐17 biological therapies for psoriasis in elderly patients: Real‐world experience from two Italian hospitals

Dear Editor, Psoriasis is a chronic inflammatory disease affecting 2%–4% of the general population worldwide.1-5 Due to the global increase in life expectancy, older patients with psoriasis constitute a growing group.2, 5 Conventional systemic drugs tend to be avoided in this subpopulation, due to the higher prevalence of comorbidities and drug interactions, whereas recurrent visits for phototherapy may not be suitable for patients with limited mobility or supported by caregivers.4 For these reasons, elderly patients with moderate-to-severe psoriasis are often undertreated.2-5 Few data are available on the use of interleukin (IL) inhibitors in the elderly, as they are often underrepresented in clinical trials.3-5 This study aimed to evaluate the effectiveness and safety of anti-IL-23 and anti-IL-17 biologics for psoriasis in over-65 patients. We collected data from two Italian hospitals' database records, including patients ≥65 years old receiving an anti-IL-23 or anti-IL-17 agent approved for psoriasis for at least 16 weeks. Eligibility for biological therapy was evaluated by using the Italian adaptation of EuroGuiDerm guideline.6 Patients with a cancer diagnosis within the previous 5 years were started on biologics because they had failed other treatments, after a discussion with the oncologist. We used Psoriasis Area and Severity Index (PASI) to assess severity at each visit. Effectiveness was evaluated by registering the percentages of patients that achieved an improvement of 75%, 90% and 100% in PASI (PASI75, PASI90 and PASI100, respectively) and that reached PASI ≤2. Safety was assessed by evaluating the rates of treatment discontinuation and the occurrence of adverse events (AEs) at each timepoint. Multivariate logistic regression was performed to identify predictors of response to different variables. A p-value of <0.05 was considered statistically significant. This study included 205 patients, with a mean age of 72.20 years (Standard Deviation [SD] 6.88). Of note, the patients ≥75 years old were 66 (32.20%). The characteristics of our population are summarized in Table 1. All patients completed 16 weeks of biological treatment, whereas 148 (72.20%) reached 52 weeks and 96 (46.83%) 104 weeks. The results concerning the effectiveness profile and multivariate analysis are shown in Figure 1. PASI 90 and 100 were achieved by 116 (78.38%) and 88 (59.46%) patients at week 52 and by 73 (76.04%) and 55 (57.29%) patients at week 104, respectively. At week 16, a higher PASI 75 response was observed in the bio-naïve subgroup (odds ratio [OR]: 3.13, 95% confidence interval [CI]: 1.19–8.22, p = 0.021) and a lower PASI90 response in patients with involvement of difficult-to-treat areas (OR: 0.28, 95% CI 0.10–0.74, p = 0.011). At week 104, we found that PASI90 response was significantly lower in the obese subgroup (OR: 0.15, 95% CI 0.02–0.94, p = 0.043). Regarding safety, biological treatment was discontinued in 30 patients, mainly due to relapses (13), followed by complete remissions (8), primary failures (6) and AEs (3). No severe AEs or new safety findings were detected. Patients affected by latent tuberculosis infection, viral hepatitis B and C did not develop disease reactivation. No new malignancies or recurrence/progression of previous cancer were found. Our study shows that IL-23 and IL-17 inhibitors were an effective treatment for psoriasis in a large cohort of elderly, also supporting their use in patients with cardiometabolic diseases, which are frequent in this subgroup.7 Despite the higher percentage of comorbidities, the most observed AEs were comparable to those reported in younger patients.3-5 As in previous studies,8-10 no signs of viral hepatitis or latent tuberculosis reactivation were observed, as well as no cancer recurrence/progression or newly diagnosed malignancies. Psoriasis management in older adults may be challenging because of individual factors and the scarce scientific recommendations.2, 4, 5 As our population gets older and the prevalence of psoriasis is increasing in the elderly, specific guidelines are needed to help increase clinician comfort when prescribing biological agents.2, 4 Our experience adds new evidence to the effectiveness and tolerability of anti-IL-23 and anti-IL-17 drugs in this subgroup; however, further studies are needed to evaluate the effectiveness and safety of the latest licensed biologics in older patients. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. M. Valenti has been a consultant and/or speaker for Sanofi, Leo Pharma, Eli Lilly, Novartis, Janssen, AbbVie, UCB-Pharma and Boehringer Ingelheim. A. Costanzo has served as an advisory board member and consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, Leo Pharma, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. A. Narcisi has served on advisory boards and received honoraria for lectures and research grants from Almirall, Abbvie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, Amgen, and Boehringer Ingelheim. L. Gargiulo has been a consultant for Almirall. The other authors have nothing to declare. The patients in this manuscript have given written informed consent to publication of their case details. The data that support the findings of this study are available from the corresponding author upon reasonable request.