Mirikizumab, a p19-directed interleukin-23 antibody, helped patients with moderate to severe plaque psoriasis achieve clear or nearly clear skin after 16 weeks of treatment, according to a study published in the British Journal of Dermatology.
Researchers of this phase 2, randomized, double-blind clinical trial (ClinicalTrials.gov identifier: NCT02899988) evaluated the safety and efficacy of 3 different dose regimens of subcutaneous mirikizumab injections in patients with moderate to severe plaque psoriasis. Patients were randomly assigned 1:1:1 to a mirikizumab 30 mg treatment arm (n=51), mirikizumab 100 mg treatment arm (n=51), mirikizumab 300 mg treatment arm (n=51), or a placebo control arm (n=52). Data collection on general demographics, psoriasis severity, dermatology quality of life, psoriasis symptoms, and adverse events were collected at time points of baseline, week 8, and week 16.
Baseline characteristics were similar for all treatment arms with an average age of 47 years, a body weight of 89 kg, a baseline Psoriasis Area and Severity Index (PASI) score of 20, and 25% of body surface area involvement.
A PASI score of 90 was achieved by week 16 in 29.4% (P =.009) of patients in the 30 mg treatment arm, 58.8% (P <.001) of those in the 100 mg treatment arm, 66.7% (P <.001) of those in the 300 mg treatment arm, and 0% of the placebo control arm participants.
Complete clearance of scalp psoriasis with a score of 0 on the Psoriasis Scalp Severity Index occurred in 43.1% of participants in the 30 mg treatment arm, 74.5% of those in the in the 100 mg treatment arm, 51% of those in the 300 mg treatment arm and 5.8% of the placebo control arm participants (P <.001 for all mirikizumab treatment arms).
Symptoms were significantly improved in all 3 treatment arms with a Psoriasis Symptoms Scale domain score of 0 occurring in 15.7% (P <.05) of participants in the 30 mg treatment arm, 27.5% (P <.05) of those in the in the 100 mg treatment arm, and 31.4% (P <.01) of those in the 300 mg treatment arm.
The most commonly reported adverse events were respiratory tract infections, injection-site pain, hypertension, and diarrhea.
Future studies need to increase the number of patients included and have a longer follow-up time frame to better calculate the overall safety and efficacy profile, compare mirikizumab to other biological therapies, and include hard to treat areas such as nail or palmoplantar psoriasis.
The researchers concluded “[m]irikizumab-treated patients had significantly higher efficacy compared to placebo, with comparable safety profiles.”
Disclosure: Eli Lilly and Company funded this study. Multiple authors report associations with pharmaceutical companies. Please refer to the original reference for a full list of authors’ disclosures.
Reich K, Rich P, Maari C, et al. Efficacy and safety of mirikizumab (LY3074828) in the treatment of moderate-to-severe plaque psoriasis: results from a randomised phase 2 study [published online February 7, 2019]. Br J Dermatol. doi: 10.1111/bjd.17628