Guselkumab beats Humira in phase 2 trial of new psoriasis treatment

[Fred]

Another new Bio in the pipeline for treating psoriasis has just beaten Humira (adalimumab) in it's phase 2 trial, guselkumab from the makers of Stelara (Janssen) is designed to block interleukin-23 and not IL-12.

Quote:

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Background:
Little is known about the effect of specific anti–interleukin-23 therapy, as compared with established anti–tumor necrosis factor therapies, for the treatment of moderate-to-severe plaque psoriasis.

Methods:
In a 52-week, phase 2, dose-ranging, randomized, double-blind, placebo-controlled, active-comparator trial, we compared guselkumab (CNTO 1959), an anti–interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis. A total of 293 patients were randomly assigned to receive guselkumab (5 mg at weeks 0 and 4 and every 12 weeks thereafter, 15 mg every 8 weeks, 50 mg at weeks 0 and 4 and every 12 weeks thereafter, 100 mg every 8 weeks, or 200 mg at weeks 0 and 4 and every 12 weeks thereafter) through week 40, placebo, or adalimumab (standard dosage for psoriasis). At week 16, patients in the placebo group crossed over to receive guselkumab at a dose of 100 mg every 8 weeks. The primary end point was the proportion of patients with a Physician’s Global Assessment (PGA) score of 0 (indicating cleared psoriasis) or 1 (indicating minimal psoriasis) at week 16.

Results:
At week 16, the proportion of patients with a PGA score of 0 or 1 was significantly higher in each guselkumab group than in the placebo group: 34% in the 5-mg group, 61% in the 15-mg group, 79% in the 50-mg group, 86% in the 100-mg group, and 83% in the 200-mg group, as compared with 7% in the placebo group (P≤0.002 for all comparisons). Moreover, the proportion was significantly higher in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (58%) (P<0.05 for all comparisons). At week 16, the proportion of patients with at least a 75% improvement in Psoriasis Area and Severity Index scores was significantly higher in each guselkumab group than in the placebo group (P<0.001 for all comparisons). At week 40, the proportion of patients with a PGA score of 0 or 1 remained significantly higher in the 50-mg, 100-mg, and 200-mg guselkumab groups than in the adalimumab group (71%, 77%, and 81%, respectively, vs. 49%) (P<0.05 for all comparisons). Between week 0 and week 16, infections were observed in 20% of the patients in the guselkumab groups, 12% in the adalimumab group, and 14% in the placebo group.

Conclusions:
The results of this phase 2 trial suggest that guselkumab may be an effective therapy for plaque psoriasis and that control of psoriasis can be achieved with specific anti–interleukin-23 therapy.

Source: nejm.org

*Funded by Janssen Research and Development.

[jiml]

They just keep coming with good news ... Ok it's a way off yet, but it's great to know that these new treatments they are trialling are proving effective and they are targeting Interluken-23, as you say in your introduction rather than IL-12
A definite step forward let's look forward to phase 3 trials and hope they are successful
This is a good time ( if it's ever good) to be diagnosed with psoriasis as there are so many new and innovative drugs in the pipeline for the future, as well as the tried and trusted treatments already available

[Fred]

Yes the future is looking good for people with psoriasis, a hell of a lot better than it was say 20 years ago that's for sure.

[jiml]

Yes the future is looking good for people with psoriasis, a hell of a lot better than it was say 20 years ago that's for sure.

Got to agree there when I was diagnosed ***years ago the treatments were to say the least primitive, we have come a long way but there is still a way to go, but I look forward to your updates they do give hope for the future