Clinical Scorecard: FDA approves tildrakizumab for psoriatic arthritis
At a Glance
Category
Detail
Condition
Active psoriatic arthritis in adults
Key Mechanisms
Tildrakizumab-asmn is a subcutaneous biologic that selectively targets the p19 subunit of interleukin-23 (IL-23).
Target Population
Adults with active psoriatic arthritis, including patients with and without prior tumor necrosis factor inhibitor exposure.
Care Setting
Treatment is administered subcutaneously by a health care professional.
Key Highlights
The FDA approved tildrakizumab-asmn (Ilumya) for adults with active psoriatic arthritis.
Approval was supported by the phase 3 INSPIRE-1 and INSPIRE-2 randomized, double-blind, placebo-controlled trials.
In a pooled analysis of 806 participants, week-24 ACR20 responses occurred in 38.8% receiving tildrakizumab and 24.4% receiving placebo.
Among participants with at least 3% body surface area affected by psoriasis, 41.0% receiving tildrakizumab and 10.9% receiving placebo achieved at least 75% improvement in Psoriasis Area and Severity Index scores.
The between-group difference in Health Assessment Questionnaire–Disability Index scores was not statistically significant.
Guideline-Based Recommendations
Diagnosis
Management
According to Sun Pharma prescribing information, tildrakizumab-asmn is administered subcutaneously by a health care professional.
Tildrakizumab-asmn is contraindicated in patients with a history of serious hypersensitivity to tildrakizumab or its excipients.
Avoid live vaccines during treatment.
Monitoring & Follow-up
Evaluate patients for tuberculosis before treatment and treat latent tuberculosis infection before initiation.
Monitor for clinically important infections; consider discontinuing treatment until serious infections resolve.
Risks
Do not administer to patients with active tuberculosis or other clinically important active infections.
The most common adverse reactions reported in patients with psoriatic arthritis, occurring in at least 3%, were upper respiratory tract infections and COVID-19.
According to Sun Pharma, no new safety signals were identified; safety findings were consistent with the established tildrakizumab profile.
Patient & Prescribing Data
Adults with active psoriatic arthritis; the supporting trials included patients with and without prior TNF inhibitor exposure.
The trials evaluated tildrakizumab 100 mg and assessed efficacy at week 24 following 2 doses. It is administered subcutaneously by a health care professional.
Clinical Best Practices
Assess for tuberculosis before starting treatment and treat latent infection before initiation.
Avoid starting or administering treatment in patients with active tuberculosis or other clinically important active infections.
Monitor for clinically important infections and consider holding treatment until serious infections resolve.
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