Clinical Scorecard: FDA approves tildrakizumab for psoriatic arthritis

At a Glance

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.
• Avoid live vaccines during treatment.

Related Resources & Content

• Sun Pharma
• American College of Rheumatology