TRANSIT study of Stelara in Psoriasis

The TRANSIT Phase IV study of Stelara (ustekinumab)from Janssen Cilag compared two methods of transiting patients from methotrexate therapy to Stelara in moderate to severe psoriasis patients. The study showed serious adverse events were infrequent regardless of transition strategy: 2.9% in the methotrexate immediate cessation arm versus 2.0% in the gradual withdrawal arm and a health related quality of life benefit as assessed by the Dermatology Quality of Life Index (DLQI)in both arms of the study. The mean improvement in DLQI over 16 weeks was shown by a reduction from 8.0 in the immediate cessation arm and 9.0 in the gradual withdrawal arm at baseline to 1.0 in both arms. The study also showed substantially improved effiacy of Stelara compared to methotrexate. By week 12, 65.3% of patients in the immediate cessation arm and 69.5% in the gradual withdrawal arm achieved a Psoriasis Global Assessment rating of 'cleared' or minimal'. The medial Psoriasis Area and severity Index (PASI) score decreased from about 15 in both arms at baseline to 2.9 in the immediate cessation arm and 2.8 in the gradual withdrawal arm. The study paves the way for an application by Janssen Cilag for use of Stelara as first line therapy in Psoriasis.Data were reported at the European Academy of Dermatology and Venereology (EADV) congress in Lisbon.