Through Year 3, ILUMYA® (tildrakizumab-asmn) was well tolerated with a low rate of adverse events of interest1*
*AEs of interest include serious infections, malignancies, non-melanoma skin cancer, melanoma, extended MACE, deaths, injection-site reactions, and drug-related hypersensitivity AEs.
†From a post hoc pooled-analysis extension study of reSURFACE 1 and 2. No imputation of missing data.
‡Extended MACE includes non-fatal myocardial infarction, non-fatal stroke, unstable angina, coronary revascularization, resuscitated cardiac arrest, and CV deaths that are confirmed as “cardiovascular” or “sudden.”
§Five subjects in the ILUMYA® 100 mg group experienced non-treatment-related fatal AEs.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, a total of 1994 subjects with plaque psoriasis were treated with ILUMYA®, of which 1083 subjects were treated with ILUMYA® 100 mg. Of these, 672 subjects were exposed for at least 12 months, 587 for 18 months, and 469 for 24 months. Data from 3 placebo-controlled trials (Trials 1, 2, and 3) in 705 subjects (mean age 46 years, 71% males, 81% white) were pooled to evaluate the safety of ILUMYA® (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 12 weeks [Q12W]).2
AE=adverse event; CV=cardiovascular; MACE=major adverse cardiovascular event.
Through Week 64, the frequency of adverse reactions was similar to that during the placebo-controlled period of the trial, and no new adverse reactions were identified2
*From the placebo-controlled period of the trial: Weeks 0-12 (reSURFACE 1 and 2); Weeks 0-16 (Clinical Trial 1).
In clinical trials, ILUMYA® demonstrated:
- One contraindication2,3
ILUMYA® has a hypersensitivity warning due to cases of angioedema and urticaria that occurred. Hypersensitivity reactions occurred at a rate of 0.1% for ILUMYA® patients and 0.3% for placebo*
*No hospitalizations were required.
- Pretreatment evaluation limited to initial TB screening2
- No routine lab monitoring required2
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. 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. 2. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc. 3. Data on File. Sun Pharmaceutical Industries, Inc. 4. Skyrizi® (risankizumab-rzaa) [package insert]. North Chicago, IL: AbbVie, Inc. 5. Tremfya® (guselkumab) [prescribing information]. Horsham, PA:. Janssen Biotech, Inc. 6. Belinchón I, Rivera R, Blanch C, Comellas M, Lizán L. Adherence, satisfaction and preferences for treatment in patients with psoriasis in the European Union: a systematic review of the literature. Patient Prefer Adherence. 2016;10:2357-2367.