Data from PIIIb COSMOS trial (NCT03796858; EudraCT2018-003214-41) presented at the virtual EULAR meeting, a study evaluating guselkumab in adult patients with active PsA, with demonstrated inadequate response or intolerance to TNF-inhibitors. This multicentre, randomised, double-blind, placebo-controlled trial was initiated in Mar 2019 and recruited 285 patients in Europe, including the UK. Results showed significantly higher proportions of patients treated with guselkumab showed joint symptom improvement (measured by ACR 20) and complete skin clearance vs placebo at week 24, with response rates further increased at 1 year 
PIII Discover-2 RCT (n=716) reports significantly greater proportions of patients in the guselkumab every 4 weeks group (64%) and every 8 weeks group (64%) achieved ACR20 at 24 weeks vs placebo (33%) [percentage differences vs placebo 31% for both; both p<0.0001) .
PIII Discover-1 RCT (n=381) is published; it reports ACR20 at week 24 was achieved by significantly greater proportions of patients in the guselkumab every 4 weeks group (59%) and every 8 weeks group (52%) than in the placebo group (22%) [differences vs placebo of 37% and 30% respectively, both p<0.0001] .
Janssen announces guselkumab meets primary endpoints in PIII DISCOVER-1 and DISCOVER-2 studies. DISCOVER-1 (n=381 including those previously treated with anti-TNFs) showed that 59% patients on guselkumab every four weeks (q4w) and 52 % who received doses at weeks 0, 4 and every eight weeks thereafter (q8w) achieved ACR20 response compared to 22% on placebo (both p<0.001). DISCOVER-2 (n=739 biologic-naïve) showed that at week 24, 64% on guselkumab q4w or q8w respectively, achieved an ACR20 response, compared to 33% on placebo (both p<0.001) .
Top-line results from PIII DISCOVER 1 and DISCOVER 2 studies have been announced. Both these studies met their primary efficacy end-point of American College of Rheumatology 20 percent improvement (ACR20). Submissions to EMA and FDA will be made based on these data [6,7].
PIII Discover-1 (NCT03162796) trial to assess the efficacy and safety of guselkumab in participants with psoriatic arthritis, including those previously treated with up to two anti-TNF alpha agents starts. Primary outcome is ACR20 response at week 24; estimated primary completion date is Oct 19 [3,4].
PIII (NCT03158285) study to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA starts. 684 adults will be recruited in sites around the world including US & EU. Primary outcome is ACR20 response at week 24; collection of thse data should complete Feb 20 .