Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: Results of the randomized, double-blind, Phase 3 NAVIGATE trial

Summary

Background

Guselkumab, an anti-interleukin-23 monoclonal antibody, demonstrated significant efficacy in Phase 3 psoriasis trials.

Objective

Evaluate the efficacy and safety of guselkumab in patients with moderate-to-severe plaque psoriasis with an inadequate response to ustekinumab.

Methods

In this Phase 3, randomized, double-blind study, 871 patients received open-label ustekinumab (45mg or 90mg) at weeks 0 and 4. At week 16, 268 patients with an inadequate response to ustekinumab (Investigator's Global Assessment [IGA] ≥2) were randomized (double-blind), to guselkumab 100mg or continue ustekinumab; 585/871(67%) patients with IGA 0/1 at week 16 continued open-label ustekinumab. The primary endpoint was the number of visits at which randomized patients achieved IGA 0/1 and ≥2 grade improvement (from week 16) from week 28-40. Improvement ≥90% or 100% in Psoriasis Area and Severity Index (PASI90/100) and Dermatology Life Quality Index (DLQI) of 0/1 were also assessed.

Results

The mean number of visits at which patients had an IGA 0/1 and ≥2-grade improvement (week 28-40) was significantly greater in the guselkumab group vs. the randomized ustekinumab group (1.5 vs. 0.7; p<0.001); greater proportions of patients achieved IGA0/1 and ≥2-grade improvement at week 28 (31.1% vs 14.3%; p=0.001) and week 52 (36.3% vs 17.3%; p<0.001). Greater proportions of guselkumab-treated patients achieved PASI90 (51.1% vs 24.1%; p<0.001), PASI100 (20.0% vs 7.5%; p=0.003), and DLQI 0/1 (38.8% vs19.0%; p=0.002) vs. the randomized ustekinumab group at week 52. After week 16, 64.4% of patients in the guselkumab group and 55.6% in the ustekinumab group had ≥1AE; infections were the most frequent AE type (41.5% and 35.3%, respectively), with nasopharyngitis and upper respiratory tract infection being the most common. Proportions of patients with ≥1 serious AE were 6.7% (n=9) for guselkumab and 4.5% (n=6) for ustekinumab.

Conclusions

Ustekinumab-treated patients who did not achieve an IGA of 0/1 by week 16 derived significant benefit from switching to guselkumab.

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