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Tremfya heads for filing in psoriatic arthritis

Lilly's Talz sets pace with Humira head-to-head


J&J’s Tremfya has hit its primary endpoints in two phase 3 studies in psoriatic arthritis (PsA) putting it on course for a filing with regulators later this year.

Tremfiya (guselkumab) is the follow-up to J&J’s IL-23/IL-12 inhibitor blockbuster Stelara, which is under assault from rival new entrants across immunology indications, most notably Novartis’ Cosentyx.

While Stelara remains in a solid second place behind runaway leader Humira, Cosentyx, AbbVie’s Skyrizi, Eli Lilly’s Taltz and Pfizer's Xeljanz also already approved in psoriatic arthritis.

J&J has unveiled top line data from the DISCOVER-1 and DISCOVER-2 phase 3 trials of Tremfya in patients with active PsA compared to placebo.

The drug hit its primary endpoint of ACR20 response at week 24, multiple secondary endpoints were assessed that included ACR50/70, resolution of soft tissue inflammation (enthesitis and dactylitis), disease activity (DAS-28 CRP), improvement in physical function (HAQ-DI), skin clearance (IGA), and quality of life (SF-36 PCS and MCS).
DISCOVER-2 also assessed effect on structural damage (vdH-S) as a key secondary endpoint.

DISCOVER-1 included 381 participants, including participants previously treated with anti-TNF biologics. The study continued through 52 weeks. DISCOVER-2 included 739 biologic-naive participants, and continued up to 100 weeks.
The study results were announced on Friday at the EULAR conference, and followed strong data from rivals.

This includes Novartis’ FUTURE 5 trial of Cosentyx in PsA, in which the company  demonstrated that Cosentyx can prevent the long term damage to joints which can ultimately disable patients. The FUTURE 5 study showed patients taking Cosentyx showed no radiographic progression in almost 90% of PsA patients over two years. Of the patients receiving the drug at 150 mg, 66.3% had rapid and significant improvements in symptoms of the disease with axial manifestations at week 12.

Probably the most eyecatching results in PsA from EULAR in Madrid, however, was Lilly's Talz in a head-to-head trial where it beat Humira.

Taltz showed itself superior to Humira in reducing PsA disease activity by half and also completely cleared patient skin after 24 weeks. Lilly's drug did show an inferior side-effect profile compared to Humira, however, with a higher rate of infections and injection-site reactions.

Article by
Andrew McConaghie

17th June 2019

From: Marketing



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