Novartis has reported promising 52-week results from its Phase III RemIND programme, showing that Rhapsido (remibrutinib) delivered early and sustained efficacy in patients with chronic inducible urticaria (CIndU), with benefits maintained for up to one year.

 

The long-term findings showed that Rhapsido 25 mg twice daily improved symptoms across the three most prevalent forms of the condition — symptomatic dermographism (SD), cold urticaria (ColdU) and cholinergic urticaria (CholU).

 

"For people living with chronic inducible urticaria, everyday triggers like cold air, heat or even light scratching on the skin can lead to sudden, painful itching and swelling that can interfere with daily life," said Giselle Mosnaim, allergist and immunologist at Endeavor Health and lead RemIND investigator. "This research is an important step toward finding treatment options that can provide lasting relief and help patients better manage their condition."

 

The RemIND programme is the largest Phase III clinical programme conducted in CIndU. Results showed that patients initially treated with Rhapsido maintained symptom improvements throughout the 52-week treatment period.

 

Importantly, patients who initially received placebo and switched to Rhapsido at Week 24 achieved response rates by Week 52 comparable to those who had received Rhapsido from the outset.

 

The findings also highlighted early treatment benefits. Complete or partial responses on subtype-specific provocation tests were recorded as early as Week 1 in patients with SD and ColdU, and by Week 2 in those with CholU.

 

At Week 1, response rates with Rhapsido versus placebo were 41.8% versus 19.2% in SD and 67.4% versus 28.9% in ColdU. In CholU, response rates at Week 2 were 65.2% versus 45.6%.

 

The benefits were sustained over the longer term. At Week 52, complete or partial response rates in the SD, ColdU and CholU cohorts were 46.8%, 83.3% and 58.2%, respectively, among patients initially assigned to Rhapsido. Among those who switched from placebo to Rhapsido at Week 24, the corresponding response rates were 47.7%, 88.9% and 69.8%.

 

The 52-week findings also add to the growing safety evidence for Rhapsido in CIndU. The drug's safety profile remained consistent with previous studies and established experience in chronic spontaneous urticaria (CSU).

 

“The RemIND program has generated the most comprehensive Phase III evidence to date in chronic inducible urticaria,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. 

 

“These long-term data further strengthen the clinical profile of Rhapsido and underscore our commitment to advancing innovative treatment options for patients living with chronic urticaria. They will help support ongoing efforts to bring Rhapsido to more patients worldwide.”