RESULTS THAT IMPROVE OVER TIME

*These endpoints were considered “other” secondary endpoints in reSURFACE 1 and 2.
From a post-hoc pooled analysis extension study of reSURFACE 1 and 2. No imputation of missing data.
All results based on the recommended 100 mg dose of ILUMYA™.
PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

*These endpoints were considered “other” secondary endpoints in reSURFACE 1 and 2.
All results based on the recommended 100 mg dose of ILUMYA™.
PASI score is a measure of overall psoriasis severity and coverage in the range of 0 (no psoriasis on the body) and up to 72 (the most severe case of psoriasis). It is calculated by assessing the Body Surface Area covered with lesions combined with an assessment of the severity of lesions based on erythema (redness), induration (thickness), and scaling.
PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

STUDY DESIGN

reSURFACE 1 and 2 were Phase 3, double-blind, placebo-controlled trials of ILUMYA™ given at Weeks 0, 4, and every 12 weeks thereafter. Patients in reSURFACE 1 (N=463) and reSURFACE 2 (N=463) with moderate-to-severe plaque psoriasis who were candidates for phototherapy or systemic therapy were randomized to ILUMYA™ 100 mg or placebo. At Week 28, patients in reSURFACE 1 initially randomized to ILUMYA™ who achieved at least PASI 75 were re-randomized to either continue initial treatment or to receive placebo up to 64 weeks. The co-primary endpoints of both trials were: 1) the proportion of subjects who achieved at least PASI 75 and 2) the proportion of subjects with a PGA 0 or 1 and at least a 2-point improvement, both at Week 12. Other evaluated outcomes included PASI 90/100 at Week 12 and PASI 75 at Week 28. reSURFACE 1 also measured maintenance of efficacy in responders up to Week 64.1,2

 

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.

CONTRAINDICATIONS

ILUMYA™ is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity

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.

Infections

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.

Immunizations

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.

Adverse Reactions

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. ILUMYA [package insert]. Princeton, NJ: Sun Pharmaceuticals, Inc. 2. Data on File. Sun Pharmaceutical Industries, Inc.