Tuesday, January 06, 2015

Janssen announces Phase 2 study of IL-23 mAb, Guselkumab in Psoriatic Arthritis

Our next issue of UpdatesPlus-Spondyloarthropathy is due to be released this week - to access this detailed report on recent events in Psoriatic Arthritis and Ankylosing Spondylitis please contact fiona.watts@leaddiscovery.co.uk
  • Janssen is developing IL-23 mAb, guselkumab as a candidate for psoriasis
  • Following reports of promising data from Phase 2b X-PLORE at AAD 2014, Janssen opened a Phase 3 psoriasis program
  • VOYAGE 1 will compare Guselkumab (100mg sc), Humira and placebo. VOYAGE 2 is similar but with a withdrawal period of up to 48wks.  A second study, NAVIGATE will evaluate guselkumab in Stelara non-responders
  • Janssen has now announced an upcoming Psoriatic Arthritis study for guselkumab.  This 150 patient study will compare guselkumab (100mg sc; q8w after initial  injections at 0 and 4wks) and placebo. 
  • Of interest, patients not demonstrating a sufficient response by 16wks will receive Stelara per label
Comments:  Stelara is viewed as offering good efficacy in psoriasis, with PASI 75 rates approaching those seen with IL-17 blockade.  Skin improvement is also impressive in Psoriatic Arthritis patients albeit falling short of values in psoriasis patients (52% and approx 70% respectively).  ACR 20 rates in Psoriatic Arthritis were similar to those expected for a TNFi.  ACR and PASI scores will be reported in the present guselkumab study and it will be be interesting to compare these to historic Stelara values.  Of note the study has an early escape option if patients achieve less than a 5% improvement in ACR score.  Unfortunately patients will switch to Stelara rather than be re-randomized to Stelara or guselkumab, thereby preventing a direct comparison

This alert is from our UpdatesPlus-Spondyloarthropathy service.  UpdatesPlus offers A unique and affordable combination of information monitoring and expert analysis across 14 therapy areas [further information]


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