BioBlast®

Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis.  Janssen reported that early skin and enthesitis responses predicted longer-term clinical response, including disease remission at week 52.

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a higher clinical remission rate than induction and maintenance treatment with either guselkumab alone or golimumab alone.

Janssen released data from a Ph 2a clinical trial of guselkumab and golimumab in ulcerative colitis.  Janssen reported that the combination induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint at 12 weeks that either treatment alone.

The UK’s NICE recommended Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis and psoriatic arthritis.

Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.

Janssen announced that the CHMP has adopted a positive opinion recommending the expanded use of Tremfya® (guselkumab) to include the treatment of adult patients with active psoriatic arthritis.

Janssen announced that the FDA has approved Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis.