High treatment success with ixekizumab in patients with psoriasis and diabetes

A marked proportion of participants from 3 phase 3 psoriasis trials with comorbid diabetes experienced a benefit in the Psoriasis Area and Severity Index (PASI) with ixekizumab. The post-hoc analysis of these trials also detected no deterioration of blood pressure, body mass index (BMI), and lipid profile.

The anti-IL-17A antibody ixekizumab has been assessed for treatment of moderate-to-severe psoriasis within the UNCOVER trials (NCT01474512, NCT01597245, NCT01646177) [1,2]. The results revealed long-term maintained efficacy and consistent safety up to 5 years of treatment. A new post-hoc analysis by Dr Alexander Egeberg (Copenhagen University Hospital Gentofte, Denmark) and colleagues investigated ixekizumab in patients suffering from type 1 or 2 diabetes mellitus at baseline [3]. The analysis included 184 patients from the 3 randomised, placebo-controlled, phase 3 UNCOVER-1, -2, and -3 studies. The participants all had a Body Surface Area (BSA) of ≥10, a static Physician Global Assessment of ≥3, and a PASI of ≥12. From the evaluated participants with diabetes, 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 rates of participants reaching PASI 75, 90, and 100 were primarily evaluated for efficacy. Of further interest were values such as blood pressure and lipids. Mixed models repeated measures and logistic regression were used for data analyses.

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 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, PASI 75 was found in 94.2% on the study drug and 2.5% on placebo. The matching outcome percentages for PASI 90 were 61.2% versus 0% and for PASI 100 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, triglycerides, BMI, or blood pressure levels.

The authors concluded that despite high BMI and PASI scores at baseline, ixekizumab was efficacious in patients with psoriasis and comorbid diabetes mellitus.

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   1. Leonardi C, et al. Dermatol Ther (Heidelb). 2020;10(3):431–447.
   2. Blauvelt A, et al. J Am Acad Dermatol. 2021;85(2):360–368.
   3. Egeberg A, et al. efficacy of ixekizumab in patients with moderate-to-severe plaque psoriasis and comorbid diabetes mellitus. P30, Psoriasis from Gene to Clinic 2021, 9–11 December.

 

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Posted on 3 February, 2022