Results

ILUMYA® CLINICAL TRIAL RESULTS THROUGH 5 YEARS

ILUMYA® (tildrakizumab-asmn) provided consistent reduction of detectable psoriasis activity through 5 years of clinical studies1,2*

  • 83% reduction in median PASI score after 2 initial injections1†
  • ≥94% reduction in median PASI score from Week 28 through Year 51,2‡
Chart showing results with ILUMYA®, and how patients maintained a ≥PASI 50 response up to 226 days after receiving their last dose of ILUMYA®Chart showing results with ILUMYA®, and how patients maintained a ≥PASI 50 response up to 226 days after receiving their last dose of ILUMYA®
Chart showing results with ILUMYA®, and how patients maintained a ≥PASI 50 response up to 226 days after receiving their last dose of ILUMYA®

*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

CLINICAL HIGHLIGHTS VIDEO: 5-YEAR DATA

Visit the Video Library to see the key attributes that make ILUMYA® a treatment your patients can depend on for the long haul.GET THE FULL STORY

Patient case studies demonstrating a measurable reduction in PASI score with ILUMYA®

CLINICAL TRIAL: PATIENT 1: PASI 75 RESPONDER
PASI18BASELINE1
WITH2 DOSES3PASI3.879% CLEARERWEEK 121ACHIEVED PASI 75reSURFACE 1vs 6% placebovs 6% placebo64%reSURFACE 261%3
WITH3 DOSES 3PASI3.481% CLEARERWEEK 281ACHIEVED PASI 75reSURFACE 174%reSURFACE 270%1,3*
CLINICAL TRIAL PATIENT 2: PASI 90 RESPONDER
PASI16.6BASELINE1
WEEK 123WITH2 DOSES3PASI2.386% CLEARERWEEK 121ACHIEVED PASI 75reSURFACE 1vs 6% placebovs 6% placebo64%reSURFACE 261%3
WITH3 DOSES3PASI0.696% CLEARERWEEK 281ACHIEVED PASI 90reSURFACE 148%reSURFACE 252%1*
Through Year 5, median absolute PASI score remained ≤ 1 for patients in the extension studies2†

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)

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.

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

†From a pooled analysis extension study of reSURFACE 1 and 2. Only PASI 75 responders continued study participation after Week 28. Data represent the recommended 100 mg group.1-3

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

Consistent improvement in PASI score regardless of high BMI and other metabolic risk factors4*

Median PASI Score Reduction From Baseline

Long-lasting improvement in PASI score seen in ILUMYA® patients with and without metabolic syndrome in reSURFACE 1 and 2.
Long-lasting improvement in PASI score seen in ILUMYA® patients with and without metabolic syndrome in reSURFACE 1 and 2.
Obesity is 114% more common in patients with moderate-to-severe plaque psoriasis compared to those without5†

ILUMYA® (tildrakizumab-asmn) does not require weight-based dosing3

Cardiometabolic risk factors including obesity, CHD, diabetes, hypertension, and hyperlipidemia are significantly more common in patients with
moderate-to-severe plaque psoriasis compared to those without5†

The efficacy and safety of ILUMYA® were studied in plaque psoriasis patients with and without metabolic syndrome in reSURFACE 1 and 2.4

ILUMYA® is approved for the treatment of adults with moderate-to-severe plaque psoriasis.3

*From a post hoc extension study of reSURFACE 1 and 2. Analysis conducted using last observation carried forward.

†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.

BMI=body mass index; CHD=coronary heart disease; MetS=metabolic syndrome; PASI=Psoriasis Area and Severity Index.

5 YEARS OF CONSISTENT SAFETY DATA2,3

Low rates of adverse events over 5 years
of continuous clinical studies2,3
See 5-Year Safety

Median time to relapse occurred over 32 weeks after last dose of ILUMYA®6*

Loss of ≥50% PASI improvement in reSURFACE 1

Chart showing results with ILUMYA®, and how patients maintained a ≥PASI 50 response up to 226 days after receiving their last dose of ILUMYA®
Chart showing results with ILUMYA®, and how patients maintained a ≥PASI 50 response up to 226 days after receiving their last dose of ILUMYA®
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*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.

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. 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. 5. 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. 6. 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.

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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.