Tildrakizumab Demonstrates Sustained Efficacy and Safety in Elderly Psoriasis Patients Over Two Years
Key Insights
A multicenter Italian study of 217 elderly patients (≥65 years) with moderate-to-severe psoriasis (search) found tildrakizumab achieved high skin clearance rates, with 75% reaching PASI 90 and 88% achieving PASI ≤2 at two years.
The study revealed no significant differences in treatment outcomes between frail and non-frail elderly patients, with 80% drug survival at 24 months and comparable safety profiles across both groups.
Only 2 of 27 treatment discontinuations were due to adverse events, with most side effects being mild and manageable, supporting tildrakizumab's favorable risk-benefit profile in this vulnerable population.
A comprehensive real-world study has demonstrated that tildrakizumab maintains robust efficacy and safety in elderly patients with moderate-to-severe psoriasis (search) over a two-year treatment period, including those classified as frail. The multicenter Italian study, involving 217 patients aged 65 and older across seven dermatology centers, represents one of the largest analyses of IL-23 (search) inhibitor therapy in this vulnerable population.
High Response Rates Sustained Over Two Years
The study revealed impressive clinical outcomes, with median PASI scores decreasing from 12 at baseline to 3 as early as 16 weeks, ultimately reaching a median PASI of 0 at the two-year mark. By the final assessment, 70% of patients achieved complete skin clearance (PASI 100), 75% reached PASI 90, and 88% maintained minimal disease activity with PASI ≤2.
Quality of life improvements paralleled the clinical response, with median DLQI scores dropping from 15 at baseline to 0 at both the one-year and two-year time points. The proportion of patients achieving DLQI 0/1 increased from 65.6% at one year to 83.3% at two years, indicating sustained improvement in patient-reported outcomes.
Frail Patients Show Comparable Outcomes
A key finding of the study was the comparable effectiveness between frail and non-frail elderly patients. Of the 217 participants, 89 patients (41%) met the study's criteria for frailty, defined as having either two major comorbidities or one major comorbidity plus low economic status, along with at least two indicators of physical decline including weight loss, weakness, sluggishness, low activity level, or exhaustion.
Despite having a higher mean age at enrollment (74 vs 72.3 years, p=0.015) and higher BMI (27.7 vs 26 kg/m², p=0.005), frail patients demonstrated similar or even slightly better response rates across all PASI endpoints. The proportions achieving PASI 90, PASI 100, and PASI ≤2 in the frail population were higher at almost all time points compared to non-frail patients.
Strong Treatment Persistence and Safety Profile
Drug survival analysis revealed an estimated retention rate of 89.6% at 12 months and 80% at 24 months. After a median follow-up of 16 months, only 27 patients (12.4%) permanently discontinued treatment. Secondary failure was the leading cause of discontinuation (44.5%), while only 2 patients (7.4%) stopped treatment due to adverse events.
The safety profile was particularly reassuring in this elderly population with multiple comorbidities. Among the 217 patients, nearly 90% had at least one comorbidity, with hypertension (search) being most common (131 patients), followed by diabetes mellitus (search) (55 patients). Major cardiovascular comorbidities affected 28.1% of patients, yet no treatment-related cardiovascular events were reported.
Only 10 patients experienced mild to moderate side effects that did not require treatment discontinuation, including upper respiratory tract infections, nausea, and minor laboratory abnormalities. Importantly, no substantial differences in adverse event rates were observed between frail and non-frail patients.
Real-World Evidence Supports Clinical Trial Data
The study's findings align with and extend the evidence base from the pivotal reSURFACE clinical trials, demonstrating that tildrakizumab's efficacy translates effectively to real-world elderly populations with complex medical histories. Unlike clinical trial populations, which often exclude older patients with multiple comorbidities, this study included patients with cardiovascular disease (search), diabetes, metabolic syndrome (search), and other age-related conditions.
The researchers noted that 66.8% of patients were biologic-naive at tildrakizumab initiation, and two-thirds used concomitant topical therapy, with nearly half using emollients and 38.2% using calcipotriene plus betamethasone combination therapy. This real-world treatment approach may have contributed to the high response rates observed.
Clinical Implications for Elderly Care
The study addresses a critical gap in psoriasis (search) management, as patients aged 65 and older represent an increasing proportion of those with moderate-to-severe disease, yet are often excluded from clinical trials. The findings suggest that age and frailty status should not be barriers to initiating IL-23 (search) inhibitor therapy in appropriate candidates.
Lead researcher Dr. Mastorino and colleagues concluded that "the presence of severe comorbidities should not be considered as a barrier to the introduction of tildrakizumab in this population." The study also highlighted potential protective effects of tildrakizumab on metabolic syndrome (search) risk factors and suggested the drug may help prevent progression to psoriatic arthritis (search) in elderly patients.
While the retrospective design and lack of a universally accepted frailty definition represent study limitations, the large sample size and two-year follow-up period provide valuable real-world evidence supporting tildrakizumab's use in elderly psoriasis (search) patients, regardless of frailty status.