Brodalumab, a human anti–interleukin-17–receptor monoclonal antibody, was shown to be highly efficacious in patients with moderate to severe plaque psoriasis, according to the results of a phase 2 study.
The extent of psoriasis is assessed on the psoriasis area-and severity index (PASI), whose values range from 0 to 72. Higher scores represent disease that is more severe. Patients whose PASI score was ≥12 and who had psoriasis on ≥10% of their bodies qualified for study inclusion.
The 12-week study randomized 198 adult patients to placebo (n=38) or to 70 mg (n=39), 140 mg (n=39), 210 mg (n=40), or 280 mg (n=42) brodalumab. The 280-mg dose was administered once per month, whereas the 70-mg, 140-mg, and 210-mg doses were administered on day 1 and again at weeks 1, 2, 4, 6, 8, and 10.
At week 12 the patients who had been administered 210 mg brodalumab showed the greatest mean improvement in PASI scores. In this group, patients improved an average of 86.3% over baseline.
The 140-mg brodalumab group had a static physician’s global assessment (PGA) of clear or minimal disease of 85%; the 70-mg, 210-mg, and 280-mg groups were 26%, 80%, and 69%, respectively. The placebo group had a static PGA of 3%.
“At week 12, the mean percentage of improvement in the PASI score was significantly greater in all the brodalumab groups than in the placebo group,” the researchers concluded. “Moreover, about 30% of the patients in the placebo group had worsening psoriasis, as shown by negative values for the secondardy PASI score.”As for adverse events, two cases of grade-3 neutropenia (1 of which was considered serious) occurred in the group administered 210 mg brodalumab. The other most common adverse events occurred in the combined brodalumab groups: upper respiratory tract infections (8%), nasopharyngitis (8%) and erythema (6%).