Sun Pharma to Present Clinical Data Abstracts for ILUMYA® (tildrakizumab-asmn) in Patients with Moderate-to-Severe Plaque Psoriasis at the AAD Virtual Meeting Experience 2021

 

PRINCETON, N.J., April 22, 2021 /PRNewswire/ -- Sun Pharmaceutical Industries Inc., USA (Sun Pharma) today announced that 12 data abstracts for ILUMYA® (tildrakizumab-asmn) in patients with moderate-to-severe plaque psoriasis will be presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021, taking place April 23-25. The data to be highlighted at this year's meeting reinforce Sun Pharma's commitment to continuing to research the long-term efficacy and safety of ILUMYA, one of the most studied IL-23 inhibitors in market.

Click to Tweet NEWS: @SunPharma_Live announces 12 data abstracts revealing long-term sustained efficacy and safety results for its treatment in moderate-to-severe plaque psoriasis at #AADVMX2021. Read more: bit.ly/3tu3UmR

"We are proud to be presenting data abstracts on ILUMYA for patients with moderate-to-severe plaque psoriasis at this year's AAD VMX," said Abhay Gandhi, CEO, Sun Pharma, North America. "The data being presented underscore our dedication to providing ongoing clinical insights into the long-term efficacy and safety of ILUMYA, an IL-23 inhibitor that helps balance the immune system from the inside out to help patients keep their moderate-to-severe plaque psoriasis under control."

ILUMYA abstracts to be presented at AAD VMX 2021

  • Efficacy of long-term tildrakizumab for plaque psoriasis: PASI 50/75/90/100 and PGA for up to 5 years of treatment in reSURFACE 2 (Abstract #25993). E-poster.
  • 5-year efficacy of tildrakizumab 100 and 200 mg by PASI 50/75/90/100 and PGA in reSURFACE 1 (Abstract #25995). E-poster.
  • Long-term efficacy of tildrakizumab 100 mg by PASI 75/90/100 and PGA in a pooled analysis of reSURFACE 1 and reSURFACE 2 through up to 4 years of treatment (Abstract #25992). E-poster.
  • Efficacy of tildrakizumab 100 mg for PASI improvement in patients with moderate to severe plaque psoriasis: Pooled analysis using nonresponder imputation from reSURFACE 1 and 2 through week 52 (Abstract #25985). E-poster.
  • Malignancies related to study drug and leading to discontinuation through 5 years of tildrakizumab exposure in 2 phase 3 clinical trials (Abstract #25357). E-poster.
  • Gastrointestinal adverse events related to study drug and leading to discontinuation through 5 years of tildrakizumab exposure in 2 phase 3 clinical trials (Abstract #25984). E-poster.
  • Serious infections and infections related to study drug and leading to discontinuation through 5 years of tildrakizumab exposure in 2 phase 3 clinical trials (Abstract #25363). E-poster.
  • Rates of individual and composite cardiovascular events through 5 years of tildrakizumab exposure in 2 phase 3 clinical trials (Abstract #25983). E-poster.
  • Safety of tildrakizumab 100 mg and 200 mg through 5 years of exposure in reSURFACE 1 (Abstract #25997). E-poster.
  • Safety of tildrakizumab 100 mg and 200 mg through 5 years of exposure in reSURFACE 2 (Abstract #25996). E-poster.
  • *Application of the statistical method to convert published PASI 50/75/90/100 into absolute PASI response rate in patients with moderate-to-severe plaque psoriasis treated with tildrakizumab based on data from the two pivotal phase 3 studies reSURFACE 1 and reSURFACE 2 (Abstract #25991). E-poster.
  • *Long-term efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who were partial responders or non-responders to etanercept: post-hoc analysis through 5 years from the reSURFACE 2 phase 3 trial (Abstract #26874). E-poster.

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

The AAD Virtual Meeting Experience 2021 is accessible via registration here

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.

Most common (≥1%) adverse reactions associated with ILUMYA include upper respiratory infections, injection site reactions, and diarrhea. Adverse reactions that occurred at rates less than 1% but greater than 0.1% in the ILUMYA group and at a higher rate than in the placebo group included dizziness and pain in extremity.

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, severe nodular 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 Pharma 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_Live.

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