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‡
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)
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. 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.