Metabolic Syndrome

METABOLIC SYNDROME
RISK FACTORS

ILUMYA® (tildrakizumab-asmn) demonstrated consistent improvement in PASI score for patients with
moderate-to-severe plaque psoriasis (PsO) and metabolic syndrome (MetS) risk factors, including high BMI1*

Median PASI score reduction in reSURFACE 1 and reSURFACE 21*

ILUMYA ® 100 mg in psoriatic patients without MetS (n=98, reSURFACE 1; n=170, reSURFACE 2)ILUMYA ® 100 mg in psoriatic patients with MetS (n=26, reSURFACE 1; n=44, reSURFACE 2)
ILUMYA ® 100mg in psoriatic patients with MetS (n=26, reSURFACE 1; n=44, reSURFACE 2)ILUMYA ® 100mg in psoriatic patients without MetS (n=98, reSURFACE 1; n=170, reSURFACE 2)
Median PASI Score Reduction Results in reSURFACE 1 and reSURFACE 2 Patients with Metabolic Syndrome Median PASI Score Reduction Results in reSURFACE 1 and reSURFACE 2 Patients with Metabolic Syndrome 92 % 89 % 96 % 93 % 92 % 89 % 97 % 94 % reSURFACE 1 reSURFACE 2 WEE K 28 reSURFACE 1 reSURFACE 2 WEE K 148
Group92%89%96%93%reSURFACE 1reSURFACE 2WEEK14892%89%97%94%reSURFACE 1reSURFACE 2WEEK28

In reSURFACE 1 and 2, ILUMYA® patients with MetS were, on average, 53 pounds heavier than patients without MetS2

ILUMYA® does not require weight-based dosing3

BASELINE TRIAL DEMOGRAPHICSPREVALENCE OF MetS IN PsO
The efficacy and safety of ILUMYA® were studied in plaque psoriasis patients with and without metabolic syndrome in reSURFACE 1 and 2.1
ILUMYA® is approved for the treatment of adults with moderate-to-severe plaque psoriasis.3
*

Cardiometabolic risk factors including obesity, coronary heart disease, diabetes, hypertension, and hyperlipidemia are significantly more common in patients with moderate-to-severe plaque psoriasis compared to those without.4

Because waist circumference was not measured in reSURFACE 1 and reSURFACE 2, the post hoc analysis of metabolic syndrome was performed using BMI ≥30 kg/m2 as a surrogate measure of central obesity rather than waist circumference >102 cm for men and >88 cm for women as specified by the National Cholesterol Education Program Adult Treatment Panel III.1,5

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

BMI=body mass index; PASI=Psoriasis Area and Severity Index.

SAFETY OUTCOMES IN
PATIENTS WITH MetS

Adverse events of interest were similar regardless of
MetS status for patients with
moderate-to-severe plaque psoriasis1
REVIEW SUBGROUP SAFETY DATA

Real-world evidence from REAL-WORLD STUDY 1 shows consistent clearance in
overweight patients compared with patients with a BMI <256

Average improvement of absolute PASI score from baseline6

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Average Improvement of Absolute PASI Score From Baseline in Patients with Metabolic Syndrome Average Improvement of Absolute PASI Score From Baseline in Patients with Metabolic Syndrome 1 2 . 5 8 7 % 9 2 % 1 8 . 7 D A Y 0 Y EA R 1 P A SI P A SI 1 . 6 P A SI 1. 5 C L EARE R C L EARE R P A SI I L UM Y A ® 100mg in psori a tic p a tie n ts with a BMI <25 I L UM Y A ® 100mg in psori a tic p a tie n ts with a BMI ≥25 Obesity is 114% more common in patients with moderate-to-severe plaque psoriasis compared to those without. 4 *
Obesity is 114% more common inpatients with moderate-to-severe plaque psoriasis compared to those without.4*92CLEARERPASI 1.587%PASI 1.6CLEARERYEAR118.7PASI12.5PASIDAY0ILUMYA®100 mg in psoriatic patients with a BMI <25ILUMYA®100 mg in psoriatic patients with a BMI ≥25

REAL-WORLD STUDY 1 was a post hoc, retrospective, observational study of patients ≥18 years of age with moderate-to-severe plaque psoriasis and treated with ILUMYA® 100 mg for at least 2 years; N=30.6

*

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; 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. 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):398407. 2. 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. 3. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc. 4. 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. 5. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106(25):3143-3421. 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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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.

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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-density lipoprotein)
  • 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.