Selective IL-23 blocker safe in elderly psoriasis patients

A post-hoc analysis of the reSURFACE 1 and 2 trials showed that tildrakizumab is well tolerated in psoriasis patients >65 years [1].

Tildrakizumab is the second selective IL-23 blocker approved for treatment of patients with moderate-to-severe psoriasis. This was based on the positive results from the phase 3 reSURFACE trial that compared tildrakizumab with placebo and the TNF blocker etanercept. In this trial, tildrakizumab was well tolerated. However, elderly patients often suffer from cardiovascular comorbidity and are a particularly vulnerable group. Therefore, the current post-hoc analysis assessed the safety profile of tildrakizumab in elderly patients ≥65 years. Data for the analysis was derived from the phase 3 reSURFACE 1 (64 weeks) and reSURFACE 2 (52 weeks) trials and their long-term extension periods.

Elderly patients were analysed in 3 groups: patients who received a dose of 100 mg tildrakizumab in at least 1 part of the study, patients who received a dose of 200 mg in at least 1 part of the study, and patients who received etanercept until week 28. Severe infections were defined as any infection meeting the definition of a serious adverse event and/or infections that required intravenous antibiotics. Confirmed extended major adverse cardiovascular events (MACEs) included non-fatal myocardial infarction, non-fatal stroke, unstable angina, coronary revascularisation, resuscitated cardiac arrest, and cardiovascular deaths. For all side effects, exposure-adjusted incidence rates were calculated.

A total of 161 elderly patients were treated with tildrakizumab up to week 148 (159.5 patient years of exposure to 100 mg; 170.8 patient years to 200 mg). Exposure to etanercept was 14.7 patient years. Exposure-adjusted incidence rates of drug-related serious adverse events were 2.5, 1.76, and 6.83 in the group with the high-dose and low-dose tildrakizumab, and the etanercept group. Per 100 years of exposure, the incidence rate of severe infections was 3.76 in the low-dose tildrakizumab group, 2.34 in the high-dose tildrakizumab group, and 6.83 in the etanercept group. The exposure-adjusted incidence rates of MACEs were low in all groups (see Table), as were the exposure incidence rates of malignancies.

The authors concluded that tildrakizumab was well tolerated in patients ≥65 years of age. Drug-related serious adverse events and MACEs were rare. Reassuringly, no dose-related increase in the rate of adverse events was observed in the 200 mg tildrakizumab group.

Table: Exposure-adjusted incidence rates of extended MACE [1]

Data are n, events per 100 patient-years. ETN, etanercept; MACE, major adverse cardiovascular event; TIL, tildrakizumab.

1. Van de Kerkhof PC, et al. P13632, AAD Virtual Meeting Experience, 12-14 June 2020.

Posted on 19 August 202019 November 2021