ILUMYA SAFETY PROFILE
In Clinical Trial 1 and reSURFACE 1 and 2ILUMYA® DEMONSTRATED 5 YEARS OF CONSISTENT SAFETY DATA1
ILUMYA® SAFETY PROFILE AND ADVERSE EVENTS
In Clinical Trial 1 and reSURFACE 1 and 2, ILUMYA® (tildrakizumab-asmn) demonstrated 5 years of consistent safety data1
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
*From a pooled-analysis extension study of reSURFACE 1 and 2.
MACE=major adverse cardiovascular event; NMSC=non-melanoma skin cancer; SAE=serious adverse event.
Rates of infections and adverse events for ILUMYA® were comparable to placebo2*
Common Infections
Serious Infections
Adverse events
Serious Adverse events
*From the placebo-controlled periods of the trials: Weeks 0-12 (reSURFACE 1 and 2); Weeks 0-16 (Clinical Trial 1).
ILUMYA® is the only IL-23 inhibitor with incidence of tinea occurring in <1% of patients in clinical trials2,4,5
*From the placebo-controlled periods of the trials: Weeks 0-12 (reSURFACE 1 and 2); Weeks 0-16 (Clinical Trial 1).
AEs of interest and SAEs associated with ILUMYA® were similar regardless of metabolic syndrome status10*
*From a post hoc extension study of reSURFACE 1 and 2.
AE=adverse event; MACE=major adverse cardiovascular event; MetS=metabolic syndrome; PY=patient-year; SAE=serious adverse event; TEAE=treatment-emergent adverse event.
In clinical trials, influenza occurred less frequently with ILUMYA® when compared with placebo3
| Incidence of Influenza in Combined Phase 2 and 3 Trials3 |
||
|---|---|---|
| TRIAL PERIOD | ILUMYA® 100 mg (n=705) |
Placebo (n=357) |
Placebo-controlled period: Weeks 0-12 %(n) |
0.9% (6) | 2% (7) |
| 52-week study and 20-week follow-up period: Rate per 100 patient-years (n) |
3.21 (32) | 8.68 (19) |
In clinical trials, ILUMYA® demonstrated:
- One contraindication3
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.
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. 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. 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. Campa M, Mansouri B, Warren R, Menter A. A review of biologic therapies targeting IL-23 and IL-17 for use in moderate-to-severe plaque psoriasis. Dermatol Ther (Heidelb). 2016;6(1):1-12. 7. Mahil SK, Capon F, Barker JN. Update on psoriasis immunopathogenesis and targeted immunotherapy. Semin Immunopathol. 2016;38(1):11-27. 8. Lowes MA, Suárez-Fariñas M, Krueger JG. Immunology of psoriasis. Annu Rev Immunol. 2014;32:227-255. 9. Kopp T, Riedl E. Bangert C, et al. Clinical improvement in psoriasis with specific targeting of interleukin-23. Nature. 2015;521(7551):222-226. 10. 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 two phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2). J Am Acad Dermatol. 2021;84(2):398-407.
*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.
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.