Kempen's preview op de komende PsA data: Any Day NoW...(dank weer AvantiAvanti)
The double-blind, placebo-controlled, phase II EQUATOR trial recruited
131 patients with moderate to severe psoriatic arthritis who have
inadequate control with cDMARDS, randomized 1:1 to filgotinib 200mg
QD or placebo on top of concurrent cDMARDs. The primary endpoint is
ACR20 on 16w (regulatory endpoint for approval), the secondary include
both rheumatoid endpoints (ACR50/70, HAQ-DI) as well psoriasis (PASI).
The trial was completed in Mar'18, and the data is expected any week now.
Tofacitinib approval sets a low bar, looking for ACR20>17%
Tofacitinib 5mg BID was recently approved in PSA despite not
demonstrating superiority to Humira, and in our view sets a low bar of
placebo adj. ACR20 of 17% to move ahead. Looking at the biologics in
PSA, (see Figure 1 below), the placebo adj. ACR20 of >25% combined with
clean safety and the convenience of oral administration should demand a
meaningful market share and position filgotinib ahead of biologics.
Safety: comforting statements
Nielsje B vulde aan: van de uiteindelijke 131 (124 initieel gedacht) zijn er 122 doorgegaan naar een open label long extension study (105 initieel gedacht). Dat kan m.i. alleen maar betekenen dat de patienten er baat bij schijnen te hebben...