NICE publishes final recommendation for ILUMETRI ®▼

final recommendation for ILUMETRI ®▼

NICE has published final recommendation for ILUMETRI ®▼ (Tildrakizumab), as a cost-effective option for adults with moderate-to-severe plaque psoriasis.

The National Institute for Health and Care Excellence (NICE) has published its final guidance approving Almirall’s ILUMETRI ® (Tildrakizumab), a humanized, high-affinity IL-23p19 monoclonal antibody, for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Following a single health technology assessment submission to NICE in August 2018 and the subsequent questions for clarification and appraisal committee meetings, NICE completed its assessment of Tildrakizumab and has recommended it as a cost effective treatment option for the NHS for the patients specified in the Final Appraisal Determination.

Tildrakizumab is a high affinity, humanised, IgG1 K antibody targeting interleukin IL 23 p19 that represents an evolving treatment strategy in chronic plaque psoriasis. Tildrakizumab constitutes an important step forward in the treatment of moderate-to-severe chronic plaque psoriasis. Tildrakizumab is administered by subcutaneous injection, every three months during maintenance.

Almirall in-licensed Tildrakizumab from Sun Pharma Global FZE (Sun Pharma) in May 2016. The agreement is for commercialisation of ILUMETRI® (Tildrakizumab) in Europe. It was approved by the European Commission in September 2018, is already available in Germany and is due to be marketed in all EU Member states.

Its approval in Europe is based on reSURFACE 1 and 2 positive results, with the dose of 100mg. Both pivotal phase III clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed that Tildrakizumab offers clinically meaningful benefits over time, which is promising news for patients and physicians.

According to both studies’ data, an average of 62% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 77% at week 28 after only three doses. Moreover, an average of 54% of patients treated with Tildrakizumab 100mg achieved PASI 90 and an average of 23% reached PASI 100 at week 28; while an average of 58% of patients treated with Tildrakizumab 200mg achieved PASI 90 and an average of 29% reached PASI 200 at week 28.

The results of a pooled analysis through three years from reSURFACE 1 and reSURFACE 2 phase III trials show the consistent maintenance of efficacy and safety over three years of Tildrakizumab in patients with moderate-to-severe plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with Tildrakizumab in 9 out of 10 patients up to week 148. More than 50% of patients reported that psoriasis no longer affected their lives after only three doses. Tildrakizumab was well-tolerated with very low drug-related serious adverse events and discontinuation rates.