Sun Pharma to Present Clinical Data Abstracts for ILUMYA® (tildrakizumab-asmn) in Patients with Moderate-to-Severe Plaque Psoriasis at 2022 AAD Annual Meeting

Abstracts to be presented at American Academy of Dermatology (AAD) include interim real-world data underscoring the safety and efficacy of ILUMYA^® in patients with moderate-to-severe plaque psoriasis

PRINCETON, N.J., March 24, 2022 /PRNewswire/ -- Sun Pharmaceutical Industries Inc., USA (Sun Pharma) today announced that five data abstracts for ILUMYA^® (tildrakizumab-asmn) in patients with moderate-to-severe plaque psoriasis will be presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting, taking place March 25-29. The data to be highlighted shows ILUMYA treatment in patients with moderate-to-severe plaque psoriasis in real-world practice resulted in significant improvement from baseline disease activity and baseline quality of life with no new safety concerns.

Click to Tweet NEWS: @SunPharma_US announces 5 data abstracts including interim real-world data on treating moderate-to-severe plaque psoriasis at #AAD2022. Read more: bit.ly/3tu3UmR

"We are thrilled to be presenting data abstracts on ILUMYA for patients with moderate-to-severe plaque psoriasis in person at this year's AAD Annual Meeting," said Stephen Rozzo, PhD, Associate Vice President and Head, Biologics Medical Affairs, Sun Pharma, North America. "This data underscores that ILUMYA has a strong safety profile and is an effective treatment option for patients with moderate-to-severe plaque psoriasis in a real-world setting and reiterates our Phase 3 clinical trial results."

ILUMYA Abstracts to be presented at the 2022 AAD Annual Meeting

• A Phase 4, real-world study of tildrakizumab in moderate to severe psoriasis: Week 28 interim analysis (Abstract #33133). E-poster.
• Real-world effectiveness and safety of tildrakizumab in patients with moderate to severe plaque psoriasis: Week 28 interim analysis of a Phase 4 study (Abstract #33129). E-poster.
• Stability of PASI <3 response to tildrakizumab through 5 years: Pooled analyses from reSURFACE 1 and reSURFACE 2 Phase 3 trials (Abstract #33025). E-poster with oral presentation.*
• Severe infections, confirmed extended major adverse cardiovascular events, and malignancies over 5 years of treatment with tildrakizumab in terms of number needed to harm: Pooled analyses from the reSURFACE 1 and reSURFACE 2 Phase 3 trials (Abstract #33124). E-poster with oral presentation.*
• Effect of tildrakizumab on work/study-related productivity: Pooled analysis from reSURFACE 1 and reSURFACE 2 Phase 3 trials (Abstract #33130). E-poster.*

*Abstract sponsored by Almirall, who markets tildrakizumab-asmn in the EU.

About the reSURFACE Extension Studies 

The Phase-3 studies (reSURFACE 1 and reSURFACE 2) were randomized, placebo-controlled, multicenter, three-part studies designed to evaluate efficacy and safety of ILUMYA 100 mg and 200 mg in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. Participants with at least a PASI 50 response at base study completion who received ILUMYA within 12 weeks of base study end (week 52 or 64) were eligible to enroll in the extension study and continued on the same ILUMYA dose once every 12 weeks. Researchers evaluated PASI responses and PGA score of 0 or 1 with ≥2 grade reduction from baseline, and incidence rates for adverse events, including severe infections, cardiovascular events, and drug-related hypersensitivities.  

About ILUMYA (tildrakizumab-asmn)

ILUMYA (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and Japan, and under the brand name ILUMETRI^® in Europe.

IMPORTANT SAFETY INFORMATION

ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any other excipients.

Cases of angioedema and urticaria occurred in ILUMYA-treated subjects in clinical trial. If a serious hypersensitivity 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 discontinue ILUMYA until the infection resolves.

Evaluate patients for 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 antiTB 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 ILUMYA 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 for ILUMYA compared to placebo are upper respiratory infections (14% vs 12%), injection site reactions (3% vs 2%), and diarrhea (2% vs 1%).

Please click here for the Full Prescribing Information.

About Sun Dermatology

Sun Dermatology (the branded dermatology division of Sun Pharmaceutical Industries Inc. in the United States) is committed to expanding its dermatology portfolio to bring more treatment options and ongoing support for healthcare providers and patients around the world. For more than 30 years, it has been dedicated to advancing the science of dermatology for a variety of conditions like plaque psoriasis, acne, minimally to moderately thick actinic keratoses of the face, scalp or upper extremities, and locally advanced basal cell carcinoma. Sun Pharmaceutical Industries Ltd., along with its subsidiaries, is ranked second in dermatology prescription volume within the U.S. per IQVIA and is the fourth largest specialty generic pharmaceutical company globally.

About Sun Pharmaceutical Industries Inc., USA

Sun Pharmaceutical Industries Inc. (USA) is a wholly owned subsidiary of Sun Pharmaceutical Industries Limited (SPIL). SPIL is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. SPIL fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_US.

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SOURCE Sun Pharmaceutical Industries Inc., USA (Sun Pharma)