In patients with moderate to severe plaque psoriasis, treatment with ixekizumab (IXE) twice weekly improves efficacy and health measures over the course of 12 weeks, regardless of psoriatic arthritis (PsA) status at baseline, according to the results of a post hoc analysis derived from 3 separate randomized phase 3 trials (UNCOVER-1 [ClinicalTrials.gov identifier: NCT01474512], UNCOVER-2 [ClinicalTrials.gov identifier: NCT01597245], and UNCOVER-3 [ClinicalTrials.gov identifier: NCT01646177]) and published in the Journal of the American Academy of Dermatology.
The investigators sought to determine whether patients with psoriasis and comorbidities such as PsA respond to treatment differently than those with psoriasis and no comorbidities.
They evaluated the 12-week efficacy and safety data associated with the use of IXE 80 mg (initial dose of 160 mg) every 2 weeks on the following parameters: skin involvement (Psoriasis Area Severity Index [PASI] response), joint pain (visual analog scale [VAS], only in patients with PsA), and quality of life (Dermatology Life Quality Index (DLQI]) from an integrated database of patients with moderate to severe plaque psoriasis, both with and without self-reported PsA, obtained from UNCOVER-1, UNCOVER-2, and UNCOVER-3.
A total of 1169 patients were randomly assigned to IXE every 2 weeks, with approximately 24% (283 of 1169) of them self-reporting PsA at baseline. Mean baseline PASI scores for IXE-treated patients with and without PsA were 21.6 and 19.6, respectively (P <.001). Likewise, baseline body surface area values were 29.1 and 26.6 in IXE-treated patients with and without PsA involvement, respectively (P <.05).
Improvements from baseline in PASI 75 (75% reduction in PASI score), PASI 90, and PASI 100 were observed in both groups of patients. There were no significant differences reported between the groups at any point with respect to any PASI response.
Among the 283 patients who self-reported PsA at baseline, mean joint pain VAS score was 47.4. Mean change from baseline in joint pain VAS improved significantly at week 1 (P <.001) and continued to improve up to week 12 (P <.001) with IXE therapy.
Total mean change in DLQI score from baseline improved in all patients as well, regardless of PsA involvement, with mean DLQI scores at baseline of 14.3 and 12.3 for those with and without PsA, respectively (P <.001). Significantly greater improvements from baseline in DLQI were observed at weeks 2 and 4 in patients without PsA vs those with PsA (P <.05).
Regarding safety, infections (27.0%) were reported among all patients, irrespective of PsA involvement. The incidence of cerebro-cardiovascular events, malignancies, and inflammatory bowel disease was low (<0.5%) among patients both with and without PsA. There were no deaths reported in the 12-week induction phases of these studies.
The investigators concluded that IXE therapy is a safe and effective treatment for the improvement of efficacy and health measures in patients with plaque psoriasis over the course of a 12-week period, regardless of a patient’s PsA status at baseline.
Gottlieb AB, Papp KA, Birbara CA, et al. The effect of psoriatic arthritis on ixekizumab clinical outcomes in moderate-to-severe psoriasis patients: a post hoc analysis [published online March 17, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.03.008