patient-case-studies

PATIENT CASE STUDIES DEMONSTRATING MEASURABLE PSORIASIS REDUCTION

Sample clearance through Week 28 in reSURFACE 1 and reSURFACE 2 with ILUMYA® (tildrakizumab-asmn)1

Baseline Psoriasis Before ILUMYA® (tildrakizumab-asmn) Treatment Baseline Psoriasis Before ILUMYA® (tildrakizumab-asmn) Treatment B A SELINE P A SI 18 1
79% Clearer Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) 79% Clearer Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) AFTER 2 DOSES 2 WEE K 12 1 P A SI 3 . 8 79% CLEARER
81% Clearer Psoriasis After Three Doses of ILUMYA® (tildrakizumab-asmn) 81% Clearer Psoriasis After Three Doses of ILUMYA® (tildrakizumab-asmn) AFTER 3 DOSES 2 WEE K 28 1 P A SI 3 . 4 81% CLEARER
Back Psoriasis Baseline Before ILUMYA® (tildrakizumab-asmn) Treatment Back Psoriasis Baseline Before ILUMYA® (tildrakizumab-asmn) Treatment B A SELINE P A SI 16 . 6 1
86% Clearer Back Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) 86% Clearer Back Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) B A SELINE P A SI 16 . 6 1 AFTER 2 DOSES WEE K 12 P A SI 2.3 86% CLEARER 1 2
96% Clearer Back Psoriasis After Three Doses of ILUMYA® (tildrakizumab-asmn) 96% Clearer Back Psoriasis After Three Doses of ILUMYA® (tildrakizumab-asmn) B A SELINE P A SI 16 . 6 1 AFTER 3 DOSES WEE K 28 P A SI 0.6 96% CLEARER 1 2
Median absolute PASI score remained ≤1 throughout the reSURFACE 1 and 2 extension studies3*

Sample clearance through 1 year from a Phase 4 real-world study1†

Back Psoriasis Baseline Before ILUMYA® (tildrakizumab-asmn) Treatment Back Psoriasis Baseline Before ILUMYA® (tildrakizumab-asmn) Treatment B A SELINE P A SI 11 . 4 1
97% Clearer Back Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) 97% Clearer Back Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) B A SELINE P A SI 16 . 6 1 AFTER 2 DOSES WEE K 16 P A SI 0.3 97% CLEARER 1 2
96% Clearer Back Psoriasis After Five Doses of ILUMYA® (tildrakizumab-asmn) 96% Clearer Back Psoriasis After Five Doses of ILUMYA® (tildrakizumab-asmn) B A SELINE P A SI 16 . 6 1 AFTER 5 DOSES WEE K 52 P A SI 0.3 97% CLEARER 1 2
Leg Psoriasis Baseline Before ILUMYA® (tildrakizumab-asmn) Treatment Leg Psoriasis Baseline Before ILUMYA® (tildrakizumab-asmn) Treatment B A SELINE P A SI 25 . 3 1
85% Clearer Leg Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) 85% Clearer Leg Psoriasis After Two Doses of ILUMYA® (tildrakizumab-asmn) B A SELINE P A SI 16 . 6 1 AFTER 2 DOSES WEE K 16 P A SI 3.9 85% CLEARER 1 2
97% Clearer Leg Psoriasis After Five Doses of ILUMYA® (tildrakizumab-asmn) 97% Clearer Leg Psoriasis After Five Doses of ILUMYA® (tildrakizumab-asmn) B A SELINE P A SI 16 . 6 1 AFTER 5 DOSES WEE K 52 P A SI 0.8 97% CLEARER 1 2

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.

*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.2,3


†From a 64-week, open-label, multicenter, Phase 4 real-world study of ILUMYA® 100 mg.

PASI=Psoriasis Area and Severity Index; PGA=Physician Global Assessment.

SIMILAR RESULTS REGARDLESS OF METABOLIC SYNDROME (MetS)

ILUMYA® demonstrated consistent clearance across MetS subgroups in the pivotal trials and one real-world study4,5
SEE METABOLIC SUBGROUP DATA

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. Data on File. Sun Pharmaceutical Industries, Inc. 2. ILUMYA® [package insert]. Princeton, NJ: Sun Pharmaceutical Industries, Inc. 3. 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. 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. 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.