ILUMYA® CLINICAL TRIAL RESULTS THROUGH 5 YEARS
ILUMYA® (tildrakizumab-asmn) provided consistent reduction of detectable psoriasis activity through 5 years of clinical studies1,2*
- 83% reduction in median PASI score after 2 initial injections1†
- ≥94% reduction in median PASI score from Week 28 through Year 51,2‡
*Based on a pooled analysis extension study of reSURFACE 1 and 2. At Week 28, responders were re-randomized to 100 mg, 200 mg, or treatment withdrawal, and non-responders (15.1%) were discontinued from therapy. Only PASI 75 responders continued study participation after Week 28. Outcomes reflect the recommended 100 mg group and median data.1-3
†Analysis conducted with non-responder imputation.
‡Analysis conducted with multiple imputation. Multiple imputation is considered more appropriate compared with NRI for reducing uncertainty when reporting long-term data and may prevent underestimation of response.2
CLINICAL HIGHLIGHTS VIDEO: 5-YEAR DATA
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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)
Absolute PASI score is a measure of overall psoriasis severity and coverage in the range of 0 (no psoriasis on the body) and up to 72 (the most severe case of psoriasis). It is calculated by assessing the body surface area covered with lesions combined with an assessment of the severity of lesions based on erythema (redness), induration (thickness), and scaling.
*These endpoints were considered “other” secondary endpoints in reSURFACE 1 and 2.
†From a pooled analysis extension study of reSURFACE 1 and 2. Only PASI 75 responders continued study participation after Week 28. Data represent the recommended 100 mg group.1-3
PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.
ILUMYA® (tildrakizumab-asmn) does not require weight-based dosing3
Cardiometabolic risk factors including obesity, CHD, diabetes, hypertension, and hyperlipidemia are significantly more common in patients with
moderate-to-severe plaque psoriasis compared to those without5†
The efficacy and safety of ILUMYA® were studied in plaque psoriasis patients with and without metabolic syndrome in reSURFACE 1 and 2.4
ILUMYA® is approved for the treatment of adults with moderate-to-severe plaque psoriasis.3
*From a post hoc extension study of reSURFACE 1 and 2. Analysis conducted using last observation carried forward.
†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; CHD=coronary heart disease; MetS=metabolic syndrome; PASI=Psoriasis Area and Severity Index.
5 YEARS OF CONSISTENT SAFETY DATA2,3
Low rates of adverse events over 5 years
of continuous clinical studies2,3
See 5-Year Safety
*Based on ILUMYA® PASI 75 responders randomized to placebo at Week 28, followed up until Week 64. Relapse analysis was limited to subjects who received at least one dose of placebo.
All results based on the recommended 100 mg dose of ILUMYA®.
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. 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. 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. 5. 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. 6. 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.