Ixekizumab: confirmed efficacy in psoriatic patients with diabetes

In a post-hoc investigation of diabetic participants in phase 3 trials, ixekizumab led to high proportions of Psoriasis Area and Severity Index amelioration.

Therapy did not change lipid profile, blood pressure, and BMI

In the UNCOVER trials (NCT01474512, NCT01597245, NCT01646177), ixekizumab showed its efficacy in treating adults with moderate-to-severe psoriasis. The new post-hoc analysis primarily investigated ixekizumab in patients suffering from type 1 or 2 diabetes mellitus at baseline¹. The analysis, presented by Dr Alexander Egeberg (Copenhagen University Hospital Gentofte, Denmark), included 184 patients from the 3 randomised, placebo-controlled, phase 3 studies UNCOVER-1, -2 and -3.

The subjects all had a Body Surface Area (BSA) of ≥10 and a PASI of ≥ 12. Of the evaluated diabetics, 103 had been randomised to an ixekizumab group and 81 to a placebo arm in the original trials. The treatment with ixekizumab was administered at a loading dose of 160 mg, followed by 80 mg every 2 weeks until week 12, and the same dose every 4 weeks through week 60. The rate of patients reaching PASI75, 90, and 100 was primarily evaluated for efficacy. Of further interest were also values like blood pressure and lipids.

As for the baseline characteristics, some variation existed between the ixekizumab and placebo groups in mean age (54.2 vs 53.7 years) and male sex (65.1% vs 71.6%), while groups were comparable for PASI (19.5 vs 20.9). In both arms, the mean Body Mass Index (BMI) was 34.8 kg/m2, and over 90% of patients had a diagnosis of type-2 diabetes. The results demonstrated significance for higher rates attaining psoriasis improvements on ixekizumab. At week 12, PASI75 was found in 94.2% on the study drug and 2.5% on placebo.

The matching outcome percentages for PASI90 were 61.2% versus 0% and for PASI100 23.3% versus 0%, respectively (P<0.001 for all comparisons). The levels of fasting serum glucose were not substantially altered by ixekizumab treatment through week 60 with a mean baseline measure of 8.7 mmol/L and 8.8 mmol/L at study completion. Further, ixekizumab did not impact cholesterol or BMI, and blood pressure levels were kept at similar levels. The authors concluded that despite high BMI and PASI scores at baseline, ixekizumab was efficacious in patients with psoriasis and comorbid diabetes mellitus.