FDA Approves Tildrakizumab for Psoriatic Arthritis Save

Sun Pharmaceuticals announced Friday that the FDA has approved its IL-23 inhibitor, tildrakizumab  (Ilumya) for use in patients with active psoriatic arthritis. This agent is already FDA approved for plaque psoriasis, and joins guselkumab and risankizumab as the third IL-23 inhibitor approved for use in PsA.

The approval is supported by Phase 3 INSPIRE-1 and INSPIRE-2 52 week, clinical trials that enrolled over 800 adults and showed the efficacy and safety of tildrakizumab in psoriatic arthritis. Safety data from these studies was consistent with the well-documented safety profile of IL-17A inhibitors. The most common adverse reactions were plaque psoriasis (≥1%): upper respiratory infections, injection site reactions, and diarrhea. Psoriatic Arthritis (≥3%): upper respiratory tract infections and COVID-19.

Product label information can be found here:

Tildrakizumab is indicated for the treatment of:

• moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
• active psoriatic arthritis in adult patients.

Dosage in active psoriatic arthritis is 100 mg SC every 12 weeks.

Hypersensitivity: Cases of angioedema and urticaria occurred.

Infection: TILDRA may increase the risk of infection. Evaluate patients for tuberculosis (TB) infection prior to initiating treatment. Avoid the use of live vaccines.

Pregnancy:  The drug (IgG antibody) does cross the placenta, and peaks during the third trimester. The potential clinical impact of tildrakizumab exposure in infants is unknown.  Tildrakizumab has been detected in the breast milk of monkeys.

Geriatrics: A total of 481 psoriatic arthritis were exposed to TILDRA 100 mg during Phase 2 and 3 trials, but only 86 subjects were 65 years and older. No safety or efficacy were observed between older and younger subjects, yet the use in the elder needs further study.

Elimination: The half-life of TILDRA is approximately 23 days.