Sun Pharma announces ILUMYATM data at American Academy of Dermatology 2019 Annual Meeting

ILUMYATM three-year data demonstrates sustained skin clearance in patients with moderate-to-severe plaque psoriasis

Sun Pharmaceutical Industries announced that one of its wholly-owned subsidiaries presented new ILUMYATM (tildrakizumab-asmn) clinical insights at the 2019 American Academy of Dermatology (AAD) Annual Meeting, including long-term data showing sustained skin clearance in some patients living with moderate-to-severe plaque psoriasis after three years of ongoing treatment with ILUMYATM.

These findings from the Phase 3 reSURFACE 1 and reSURFACE 2 studies showed sustained response by some patients over time and ILUMYATM was well tolerated with low rates of adverse events. After up to 5 years of treatment, all prespecified adverse events were reported at rates <1.6 and <1.3 events per 100 patient-years in reSURFACE 1 and reSURFACE 2, respectively. Of the adverse events of interest, severe infections (1.2 and 1.5 events per 100 patient-years, respectively) and malignancies (1.2 and 0.5 events per 100 patient-years, respectively) were the most frequently reported.

The US FDA approval of ILUMYATM for adults with moderate-to-severe plaque psoriasis, who are candidates for systemic or phototherapy, is based on 64-week and 52-week reSURFACE data.

“It’s encouraging to see these effective response rates with ILUMYATM over a three-year period, because as clinicians we’re often faced with the challenge of finding the right treatment that addresses the chronic nature of plaque psoriasis. We’re also starting to learn more about which patients ILUMYATM may be a fit for,” said Dr Andrew Blauvelt, board-certified dermatologist and President of Oregon Medical Research Center.

“In a one-year analysis we saw that ILUMYATM showed similar results of skin clearance in both patients who were new to biologic therapy and those who had previously been treated with another biologic. Furthermore, with its HCP administration model ILUMYATM supports treatment adherence and may be a good treatment option for patients who are starting their first biologic treatment or those who have failed previous therapy.”

Results from bio-naïve and bio-experienced patients showed that treatment with ILUMYATM achieved a PASI ≥50 response at Week 28 and was maintained or continued to increase at Week 52, regardless of the patient’s previous exposure to biologic treatment.

Furthermore, additional one-year data analyses presented during the 2019 AAD Annual Meeting show that ILUMYATM is similarly effective and safe for moderate-to-severe plaque psoriasis patients who have the common condition metabolic syndrome and those who do not. People with psoriasis are predisposed to metabolic syndrome, and psoriasis has been shown to increase the prevalence of metabolic syndrome by three-fold. Patients with moderate-to-severe plaque psoriasis treated with ILUMYATM 100 mg who achieved PASI 75 at Week 52 were comparable between those with metabolic syndrome (84 per cent [0.04]) and without (90 per cent [0.02]) and reported similar adverse events, with no reports of cardiovascular events or diabetes worsening by metabolic syndrome status. The most common treatment-emergent adverse event was infection, occurring in 50.6 per cent [n=40] of patients with metabolic syndrome and 53.1 per cent [n=154] of patients without. The most commonly reported serious adverse events (>1.5% of patients with ≥1 SAE) in patients with metabolic syndrome were gastrointestinal and cardiac disorders.

“As we expand our knowledge and understanding of the potential ILUMYATM has for different patients, we’re excited to see the clinically meaningful benefits this treatment option may continue to offer,” said Abhay Gandhi, President and CEO, Sun Pharmaceutical Industries. “These insights are promising news for patients and clinicians, and we’re committed to helping those with moderate-to-severe psoriasis for whom ILUMYATM may be a good treatment option.”

Additional analyses presented used the 10-year Markov model to demonstrate the cost-effectiveness of ILUMYATM as a first-line treatment. The data results demonstrated that ILUMYATM is among the most cost-effective options compared to other biologic options including secukinumab, guselkumab, ixekizumab, adalimumab, ustekinumab, and etanercept.