Johnson and Johnson (JNJ) has been in news in the last few days, but for the wrong reasons – product recall and allegations of bribery. However, the company received some good news recently on one of its products. Johnson and Johnson announced findings from a phase III clinical study comparing the effectiveness and safety of Stelara (ustekinumab) with Amgen/ Wyeth’s (now a part of Pfizer) (AMGN/PFE) Enbrel (etanercept) for the treatment of plaque psoriasis. 

Earlier in September 2009, Stelara received the US Food and Drug Administration (FDA) approval for the treatment of patients with plaque psoriasis. Johnson and Johnson took a major risk conducting a head-to-head trial with one of the established drugs in this area, Enbrel and it paid off. The drug is one of the most significant drugs in Amgen’s portfolio, recording 2008 sales of $3.6 billion, and accounting for 24% of its total revenues.
 
The phase III trial was conducted with 903 patients with chronic plaque psoriasis. Patients were randomized to receive either Stelara [in two dosage forms – 45 mg (209) and 90 mg (347)] or Enbrel (347). While patients on Stelara received the drug (in both doses) at weeks zero and four, those on Enbrel received twice-weekly doses of 50 mg for 12 weeks. It was observed that over a 12-week period, Stelara showed higher clinical response – 75% improvement in severity of its disease symptoms in 56.8% of patients –compared to Enbrel over a 12-week period. In addition, Stelara was found to be effective in patients who did not respond to Enbrel. Findings from the study were published in the January issue of The New England Journal of Medicine. 

Psoriasis is an inflammatory disorder characterized by raised, inflamed, red lesions, or plaques leading to physical pain. As per estimates, approximately 3% of the world’s population suffers from psoriasis. Plaque psoriasis is the most common form of psoriasis, occurring in about 80% of patients suffering from this condition. We believe, following positive data, Stelara should be able to record robust sales in the forthcoming period.
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