Results

ILUMYA® PIVOTAL TRIAL RESULTS THROUGH 5 YEARS

ILUMYA® (tildrakizumab-asmn) provided consistent reduction of detectable psoriasis activity throughout the 5-year
extension studies of reSURFACE 1 and reSURFACE 21,2*

  • 83% reduction in median PASI score after 2 initial injections1†
  • ≥94% reduction in median PASI score from Week 28 through Year 51,2‡
Median Absolute PASI Score Through 5 Years of ILUMYA (tildrakizumab-asmn). Median Absolute PASI Score Through 5 Years of ILUMYA (tildrakizumab-asmn). < polygon id="results-g1-path-1" points="0 0 14 0 14 38 0 38"> ILUMYA® is dosed at Weeks 0, 4, and every 12 weeks thereafter.317.9Baseline048121620Week0Median Absolute PASI ScoreTime17.715.6ILUMYA® 100 mgPlacebo2.90.81.05n=6161,2†n=3292‡96%Clearer0.994%ClearerWEEK12YEAR1YEAR5WEEK2883%Clearer
Group 3 ILUMYA® is dosed at Weeks 0, 4, and every 12 weeks thereafter.3Placebon=310 (Weeks 0-12)3†PASI 17.71†12%ClearerPASI 15.61†≥94% median PASI improvement from Week 28 (PASI 0.9) through Year 5 (PASI 1.05)2,3‡1†PASI 17.91†PASI 2.9Clearer83%Clearer95%Clearer96%94%ClearerPASI 1.051,2PASI 0.81‡PASI 0.91‡ILUMYA® 100 mg n=616 (Weeks 0-28)1,3†n=329 (Weeks 28-244)2‡Year 5Week 0Week 12Week 28Year 1

*Based on a pooled analysis extension study of reSURFACE 1 and 2. At Week 28, responders were re-randomized to 100 mg, 200 mg, or treatment withdrawal, and non-responders (15.1%) were discontinued from therapy. Only PASI 75 responders continued study participation after Week 28. Outcomes reflect the recommended 100 mg group and median data.1-3

†Analysis conducted with non-responder imputation.

‡Analysis conducted with multiple imputation. Multiple imputation is considered more appropriate compared with NRI for reducing uncertainty when reporting long-term data and may prevent underestimation of response.2

Co-primary endpoints: PGA 0 or 1 with at least a 2-point improvement, and PASI 75, both at Week 123

  • After 2 doses, by Week 12, 58% and 55% achieved PGA 0 or 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)

REAL-WORLD EVIDENCE WAS CONSISTENT
WITH PIVOTAL TRIALS

ILUMYA® demonstrated durable PASI improvement across 3
independent studies4-6
SEE REAL-WORLD EFFICACY

REAL-WORLD EVIDENCE WAS CLEAR AND CONSISTENT

ILUMYA® demonstrated durable PASI improvement
across 3 independent studies4-6
SEE REAL-WORLD EFFICACY

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. Thaçi D, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021;185(2):323-334. 3. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc. 4. Burlando M, Castelli R, CozzaniE, Parodi A, Treatment of moderate-to-severe plaque psoriasis with tildrakizumab in the real-life setting. Drugs Context. 2021 May 21;10:2021-2-6. 5. Costanzo A, Cuccia A, Daudén E, et al. Tildrakizumab demonstrates high efficacy and a favourable safety profile in conditions close to real clinical practice in patients with moderate-to-severe chronic plaque psoriasis. Paper presented at: 31st Congress of the European Academy of Dermatology and Venereology (EADV); September 7-10, 2022; Milano, Lombardia, Italy. 6. Wei NW, Chi S, Lebwohl MG. Retrospective analysis in patients with moderate to severe plaque psoriasis treated with tildrakizumab: real-life clinical data. J Psoriasis Psoriatic Arthritis. 2022;7(2):55-59.

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reSURFACE 1 trial design1-3

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.1,3

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

Extension study eligibility

Patients receiving ILUMYA® who completed the 64-week reSURFACE 1 base study with ≥50% improvement from baseline PASI score could enter the 192-week extension studies continuing the same dose.

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

Extension study eligibility

Patients receiving ILUMYA® who completed the 64-week reSURFACE 1 base study with ≥50% improvement from baseline PASI score could enter the 192-week extension studies continuing the same dose.

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, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol.2021;185(2):323-334.

reSURFACE 2 trial design1-3

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.1,3

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

Extension study eligibility

Patients receiving ILUMYA® who completed the 52-week reSURFACE 2 base study with ≥50% improvement from baseline PASI score could enter the 192-week extension studies continuing the same dose.

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

Extension study eligibility

Patients receiving ILUMYA® who completed the 52-week reSURFACE 2 base study with ≥50% improvement from baseline PASI score could enter the 192-week extension studies continuing the same dose.

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, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021;185(2):323-334.

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Patients can be diagnosed with metabolic syndrome if 3 of the following 5 cardiometabolic risk factors are present1*:

  • Obesity
  • High Blood Glucose
  • Hypertension
  • Low HDL
  • High Triglyceride Levels

Cardiometabolic risk factors are significantly more common in patients with moderate-to-severe plaque psoriasis compared with patients without moderate-to-severe plaque psoriasis2†:

*Per guidelines set by the National Cholesterol Education Program Adult Treatment Panel III.

†According to a 2015 retrospective database analysis (N=5492) comparing the prevalence of comorbidities, healthcare resource utilization, and costs between moderate-to-severe plaque psoriasis patients and demographically matched controls.

CHD=coronary heart disease; HDL=high-density lipoprotein; PsO=psoriasis.

References: 1. Alberti KGMM, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009;120(16):1640-1645. 2. Feldman SR, Zhao Y, Shi L, Tran MH. Economic and comorbidity burden among patients with moderate-to-severe psoriasis.J Manag Care Spec Pharm. 2015;21(10):874-888.

Prevalence of Metabolic Syndrome in ILUMYA® (tildrakizumab-asmn) clinical trials

Mean Baseline Demographics and Disease Characteristics in reSURFACE 1 and 21
ILUMYA® 100 mg
Without
Metabolic Syndrome
(n=290)
With
Metabolic Syndrome
(n=79)
Age, y 44.7 47.4
Sex, n (%) Female 89 (30.7%) 20 (25.3%)
Male 201 (69.3%) 59 (74.7%)
Weight at baseline, kg 82.9 106.9
BMI, kg/m2 27.9* 35.7
Body surface area, % 32.4 31.4
Disease duration, y 16.6 15.4
Baseline PASI score 19.8 20.8
CV disorders, n (%): No 241 (83.1%) 39 (49.4%)
Yes 49 (16.9%) 40 (50.6%)
Diabetes, n (%): No 275 (94.8%) 64 (81%)
Yes 15 (5.2%) 15 (19.0%)
PsA, n (%)†: No 247 (85.2%) 62 (78.5%)
Yes 43 (14.8%) 17 (21.5%)

Retrospective clinical evaluation of baseline MetS status was based on NCEP ATP III criteria. Waist circumference was not measured in reSURFACE 1/2, so body mass index—which correlates well with waist circumference and MetS status—was used as a surrogate for the abdominal obesity component of MetS. Patients meeting ≥3 of the following 5 criteria were classified as having MetS: BMI >30 kg/m2, triglycerides ≥150 mg/dL, high-density lipoprotein cholesterol <40 mg/dL for men or <50 mg/dL for women, blood pressure ≥130 mm Hg (systolic) and/or ≥85 mm Hg (diastolic), and fasting glucose ≥110 mg/dL.2

Data presented as mean unless otherwise indicated. Bold data indicate clinically relevant differences in baseline demographics and disease characteristics between patients with MetS and those without MetS.

*n=289.

†Data not available for missing patients in each group.

BMI=body mass index; CV=cardiovascular; MetS=metabolic syndrome; NCEP ATP III=third report of the National Cholesterol Education Program Adult Treatment Panel; PsA=psoriatic arthritis.

References: 1. Leonardi C, Mehta NN, Lebwohl MG, et al. Safety of tildrakizumab in patients with preexisting metabolic syndrome: long-term data from the post hoc analysis of 2 phase 3 clinical studies (reSURFACE 1 and reSURFACE 2). Poster presented at: 28th Congress of the European Academy of Dermatology and Venereology (EADV); October 9-13, 2019; Madrid, Spain. 2. Lebwohl MG, Leonardi CL, Mehta NN, et al. Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: long-term results from 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2). J Am Acad Dermatol. 2021;84(2):398-407.