Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to 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 three 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])1.
*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.
AE=adverse event; CV=cardiovascular; MACE=major adverse cardiovascular events.
SAY YES TO A BIOLOGIC WITH TRIAL RESULTS THAT DEMONSTRATED:
- One contraindication1,3
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 screening1
- Durable safety profile1
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 identified
ILUMYA™ may increase the risk of infection
The most common (≥1%) adverse reactions that were more frequent than in the placebo group are upper respiratory infections, injection-site reactions, and diarrhea
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. ILUMYA [package insert]. Princeton, NJ: Sun Pharmaceuticals, Inc. 2. Thaci 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. 3. Data on File. Sun Pharmaceutical Industries, Inc.