IMPROVED PASI THROUGH WEEK 148

HAVE CONFIDENCE IN LONG-TERM RESULTS WITH ILUMYA®

Through Year 3, ILUMYA® (tildrakizumab-asmn) minimized residual disease activity and delivered consistent, long-term clearance of moderate-to-severe plaque psoriasis in reSURFACE 1 and 21*

At Week 28, responders were re-randomized to 100 mg, 200 mg, or treatment withdrawal, and non-responders (14.4%) were discontinued from therapy. Data represent the recommended 100 mg group.1,2

*From a pooled analysis of reSURFACE 1 and 2. Conducted with non-responder imputation.

Co-primary endpoints: PGA 0/1 with at least a 2-point improvement, and PASI 75, both at Week 122

  • After 2 doses, by Week 12, 58% and 55% achieved PGA 0/1 (reSURFACE 1 and reSURFACE 2, respectively)
    – vs placebo: 7% and 4% (reSURFACE 1 and reSURFACE 2, respectively)
  • After 2 doses, by Week 12, 64% and 61% achieved PASI 75 (reSURFACE 1 and reSURFACE 2, respectively)
    – vs placebo: 6% and 6% (reSURFACE 1 and reSURFACE 2, respectively)

*These endpoints were considered “other” secondary endpoints in reSURFACE 1 and 2.

Absolute 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.

*Based on ILUMYA® PASI 75 responders randomized to placebo at Week 28, followed up until Week 64. Relapse analysis was limited to subjects who received at least one dose of placebo.

All results based on the recommended 100 mg dose of ILUMYA®.

PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

DURABLE SAFETY PROFILE

From Clinical Trial 1 and reSURFACE 1 and 23

See 3-Year Safety

ENHANCE ADHERENCE

Help improve treatment compliance with
in-office administration of ILUMYA®4

SEE QUARTERLY DOSING

DURABLE SAFETY PROFILE

From Clinical Trial 1 and reSURFACE 1 and 23

See 3-Year Safety

ENHANCE ADHERENCE

Help improve treatment compliance with in-office administration of ILUMYA®4

SEE QUARTERLY DOSING

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. 3. Thaçi D, Iversen L, Pau-Charles I, et al. Long-term efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who were responders at week 28: pooled analysis through 3 years (148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials. Paper presented at: 27th Congress of the European Academy of Dermatology and Venereology (EADV); September 12-16, 2018; Paris, France. 4. Belinchón I, Rivera R, Blanch C, Comellas M, Lizán L. Adherence, satisfaction and preferences for treatment in patients with psoriasis in the European Union: a systematic review of the literature. Patient Prefer Adherence. 2016;10:2357-2367.

Close

reSURFACE 1 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ILUMYA® (tildrakizumab-asmn) dosed at Weeks 0, 4, and every 12 weeks thereafter. Patients 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 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.1,2

Co-primary endpoints

  • Proportion of subjects with a PGA 0 or 1 and at least a 2-point improvement, both at Week 12
  • Proportion of subjects who achieved at least PASI 75

Other evaluated outcomes

  • PASI 90/100 at Week 12
  • PASI 75 at Week 28
  • Maintenance of efficacy in responders up to Week 64

Base study eligibility

  • ≥18 years of age
  • Candidate for systemic therapy or phototherapy
  • PGA score ≥3, PASI score ≥12, and ≥10% BSA involvement
  • Subjects with guttate, erythrodermic, or pustular psoriasis were excluded

BSA=body surface area; PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

Base study eligibility

  • ≥18 years of age
  • Candidate for systemic therapy or phototherapy
  • PGA score ≥3, PASI score ≥12, and ≥10% BSA involvement
  • Subjects with guttate, erythrodermic, or pustular psoriasis were excluded

Other evaluated outcomes

  • PASI 90/100 at Week 12
  • PASI 75 at Week 28
  • Maintenance of efficacy in responders up to Week 64

reSURFACE 1 and 2 baseline characteristics

ILUMYA® 100 mg and placebo treatment groups

  • 69% men, 80% white, mean age: 46
  • 17.8 median PASI score
  • 27% BSA involvement
  • 33% PGA 4/5
  • 18% prior biologic therapy for psoriasis

BSA=body surface area; PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

References: 1. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc. 2. Data on File. Sun Pharmaceutical Industries, Inc. 3. Thaçi D, Iversen L, Pau-Charles I, et al. Long-term efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who were responders at week 28: pooled analysis through 3 years (148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials. Paper presented at: 27th Congress of the European Academy of Dermatology and Venereology (EADV); September 12-16, 2018; Paris, France.

reSURFACE 2 was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial of ILUMYA® (tildrakizumab-asmn) dosed at Weeks 0, 4, and every 12 weeks thereafter. Patients with moderate-to-severe plaque psoriasis who were candidates for phototherapy or systemic therapy were randomized to ILUMYA® 100 mg or placebo.1,2

Co-primary endpoints

  • Proportion of subjects with a PGA 0 or 1 and at least a 2-point improvement, both at Week 12
  • Proportion of subjects who achieved at least PASI 75

Other evaluated outcomes

  • PASI 90/100 at Week 12
  • PASI 75 at Week 28
  • Maintenance of efficacy in responders up to Week 64

Base study eligibility

  • ≥18 years of age
  • Candidate for systemic therapy or phototherapy
  • PGA score ≥3, PASI score ≥12, and ≥10% BSA involvement
  • Subjects with guttate, erythrodermic, or pustular psoriasis were excluded

BSA=body surface area; PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

Other evaluated outcomes

  • PASI 90/100 at Week 12
  • PASI 75 at Week 28
  • Maintenance of efficacy in responders up to Week 64

Base study eligibility

  • ≥18 years of age
  • Candidate for systemic therapy or phototherapy
  • PGA score ≥3, PASI score ≥12, and ≥10% BSA involvement
  • Subjects with guttate, erythrodermic, or pustular psoriasis were excluded

reSURFACE 1 and 2 baseline characteristics

ILUMYA® 100 mg and placebo treatment groups

  • 69% men, 80% white, mean age: 46
  • 17.8 median PASI score
  • 27% BSA involvement
  • 33% PGA 4/5
  • 18% prior biologic therapy for psoriasis

BSA=body surface area; PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

References: 1. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc. 2. Data on File. Sun Pharmaceutical Industries, Inc. 3. Thaçi D, Iversen L, Pau-Charles I, et al. Long-term efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who were responders at week 28: pooled analysis through 3 years (148 weeks) from reSURFACE 1 and reSURFACE 2 phase 3 trials. Paper presented at: 27th Congress of the European Academy of Dermatology and Venereology (EADV); September 12-16, 2018; Paris, France.