NEW SCALP PSORIASIS DATA:
SIGNIFICANT REDUCTION AT WEEK 161,2*
Based on the proportion of patients achieving the primary and first key secondary endpoints in a Phase 3 study1,2*
ILUMYA® maintained a consistent safety profile and no new adverse events were detected1
STUDY DESIGN: Trial 4 was a multicenter, randomized, double-blind, placebo-controlled trial of 231 patients with moderate-to-severe psoriasis of the scalp who were treated with ILUMYA® 100 mg (n=117) or placebo (n=114) at Week 0 and 4 and every 12 weeks thereafter. Of the 231 randomized patients, 217 patients completed Part 1 (Day 1 to Week 16). For Week 16 to Week 52, patients randomized to placebo were switched to ILUMYA® receiving 100 mg at Weeks 16, 20, 32, and 44.1
*The primary and key secondary endpoints were analyzed with non-responder imputation. The P value was less than the prespecified α level of 0.0025 and was, therefore, considered highly statistically significant.
†Based on the IGA modified 2011 (scalp) score of 0 or 1 (“clear” or “almost clear”).
‡Based on the safety population in Trial 4 (n=117, ILUMYA® 100 mg; n=114, placebo).
IGA=Investigator Global Assessment; PSSI=Psoriasis Scalp Severity Index.
INDICATION AND IMPORTANT SAFETY INFORMATION
ILUMYA® (tildrakizumab-asmn) is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trials. If a serious allergic reaction occurs, discontinue ILUMYA immediately and initiate appropriate therapy.
ILUMYA may increase the risk of infection. Treatment with ILUMYA should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated.
Consider the risks and benefits of treatment prior to prescribing ILUMYA in patients with a chronic infection or a history of recurrent infection. Instruct patients receiving ILUMYA to seek medical help if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops a clinically important or serious infection, or is not responding to standard therapy, closely monitor and consider discontinuation of ILUMYA until the infection resolves.
Pretreatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with ILUMYA. Do not administer ILUMYA to patients with active TB infection. Initiate treatment of latent TB prior to administering ILUMYA. Consider anti-TB therapy prior to initiation of ILUMYA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Patients receiving ILUMYA should be monitored closely for signs and symptoms of active TB during and after treatment.
Prior to initiating therapy with ILUMYA, consider completion of all age-appropriate immunizations according to current immunization guidelines. Patients treated with ILUMYA should not receive live vaccines.
The most common (≥1%) adverse reactions associated with ILUMYA treatment that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea.
Please see full Prescribing Information.
References: 1. Data on File. Sun Pharmaceutical Industries, Inc. 2. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc.