Over the past few days, Johnson and Johnson (JNJ) has been getting pretty bad press, with recalls and allegations of bribery. However, it had some pretty good news in psoriasis, which has got little press.
Psoriasis is a reasonably big market and its treatment, at least among the biologics, is dominated by Amgen's (AMGN) Enbrel (with Abbott's (ABT) Humira nipping at its heels). With advances in understanding of the biology of Psoriasis, a couple of companies have developed antibodies to IL-12/IL-23 (interleukin 12 and 23). J&J's Stelara (a smart name since Psoriasis is responsive to solar exposure) is the leader in this approach, and it was approved for treatment of plaque psoriasis by the FDA on Sep 25, 2009.
Centocor, the J&J division that developed Stelara, took a major gamble but doing something rarely done in the pharmaceutical industry. It conducted a head to head study, comparing Stelara to Enbrel. This was risky - if the gambit failed, Stelara would be doomed to playing the third (or worse) fiddle. But as published in the New England Journal of Medicine (362;2, January 14, 2010), Stelara did much better than Enbrel.
In a 12 week cross-over trial, 903 patients were evaluated after treatment with Enbrel 50 mg twice weekly, Stelara 45 mg, and Stelara 90 mg at week 0 and 4. There was at least 75% improvement in the psoriasis area severity index (PASI) score at week 12 in 67.5% of patients who received 45 mg of Stelara and 73.8% of patients who received 90 mg, as compared with 56.8% of those who received Enbrel (P = 0.01 and P<0.001, respectively). Similarly, 65.1% of patients who received 45 mg of Stelara and 70.6% of patients who received 90 mg of Stelara had cleared or minimal disease according to the physician’s global assessment, as compared with 49.0% of those who received Enbrel (P<0.001 for both comparisons). Among patients who did not have a response to Enbrel, 48.9% had at least 75% improvement in the PASI within 12 weeks after crossover to Stelara.
The safety profile was similar: one or more adverse events occurred through week 12 in 66.0% of patients who received 45 mg of Stelara and 69.2% of patients who received 90 mg of Stelara and in 70.0% who received Enbrel; 1.9%, 1.2%, and 1.2%, respectively, had serious adverse events.
So while Stelara seems better than Enbrel in the treatment of plaque psoriasis, that is not the case with psoriatic arthritis. At least not yet. J&J is conducting a phase III study of Stelara in patients with Psoriatic Arthritis (at least according to clincaltrials.gov). If it is as successful there as it has been in Plaque Psoriasis, it could very well become the market leader. But it can’t rest on its laurels since other biotechnology and pharmaceutical companies are also developing drugs targeting IL-12/23.
Disclosure: No positions