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*
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
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
From a post hoc extension study of reSURFACE 1 and 2. Analysis conducted using last observation carried forward.
Real-world evidence from REAL-WORLD STUDY 1 shows consistent clearance in
overweight patients compared with patients with a BMI <256
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.
ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.
WARNINGS AND PRECAUTIONS
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.
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.
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.
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.