RESULTS Scalp Response

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*

Group 2Tildrakizumab 100 mg (n=89)Placebo (n=82)7X more ILUMYA ® patients were clear or almost clear (scalp) at Week 16 vs placebo1,2 *† Percentage of PatientsPercentage of Patients01020304050Week 16 7% 49%

Primary endpoint: IGA (scalp) score of 0 or 1 with a ≥2-point improvement at Week 161,2*†:

Percentage of ILUMYA® (tildrakizumab-asmn) Scalp Patients Clear or Almost Clear at Week 16 vs Placebo Percentage of ILUMYA® (tildrakizumab-asmn) Scalp Patients Clear or Almost Clear at Week 16 vs Placebo Tildrakizumab 100 mg (n=89) Placebo (n=82) 7X more ILUMYA ® patients were clear or almost clear (scalp) at Week 16 vs placebo 1,2 * † Percentage of Patients Percentage of Patients 0 10 20 30 40 50 P<0.00001 vs placebo Week 16 7% 49%

Primary endpoint: IGA (scalp) score of 0 or 1 with a ≥2-point improvement at Week
161,2*†:

Percentage of ILUMYA® (tildrakizumab-asmn) Scalp Patients who Improved in PSSI from Baseline to Week 16 Percentage of ILUMYA® (tildrakizumab-asmn) Scalp Patients who Improved in PSSI from Baseline to Week 16 80% average improvement in PSSI from baseline to Week 16 1 * † 0 10 20 30 40 50 P<0.00001 vs placebo Week 16 61 % 60 Percentage of Patients 5%

First key secondary endpoint: PSSI ≥90 at
Week 161,2*:

Group 3ILUMYA® maintained a consistent safety profile and no new adverse events were detected180% average improvement in PSSI from baseline to Week 161*†01020304050Week 1661% 60Percentage of Patients5%

First key secondary endpoint: PSSI ≥90 at Week 161,2*:

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.

SAFETY OUTCOMES IN SCALP PSORIASIS

ILUMYA® maintained a favorable safety profile with no new
adverse events in a Phase 3 study1
SEE SAFETY VS PLACEBO

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