OBJECTIVES:

Guselkumab is an anti-interleukin-23 monoclonal antibody shown to be superior versus adalimumab and placebo in Voyage 1&2, two large Phase III trials of patients with moderate-to-severe psoriasis. The Navigate trial showed superiority versus ustekinumab in patients with an inadequate response to ustekinumab. No direct comparison is available between guselkumab and ustekinumab in ustekinumab-naïve patients. As such, an adjusted comparative analysis was performed to compare efficacy of guselkumab versus ustekinumab, using pooled patient-level trial data from Voyage 1&2 and Navigate, adjusting for cross-trial population differences.

METHODS:

Patient level data, including baseline characteristics and outcome data on PASI 75, 90 and 100 responses at weeks 16, 28 and 40, from the guselkumab-arms of Voyage 1&2 were pooled with the data from the ustekinumab-arm from Navigate. To adjust for differences in patient characteristics across trials, a multivariate logistic regression model was estimated, including the following baseline characteristics: age, gender, BMI, psoriasis duration, PASI and IGA scores, BSA, presence of psoriatic arthritis, and exposure to prior systemic and biological treatments.

RESULTS:

Patients on guselkumab (n=825) had generally similar baseline characteristics compared to patients on ustekinumab (n=718).The probability of reaching a PASI 90 response was significantly higher for guselkumab at weeks 16 (OR=2.70 [2.17;3.33]), 28 (OR=2.27 [1.79;2.94]) and 40 (OR=2.38 [1.85;3.03]) (all p<=0.0001), after adjusting for baseline characteristics. Similar results were obtained for the probability of reaching PASI 75 and 100 responses across all timepoints.

CONCLUSIONS:

An adjusted comparison using patient level data from Phase III studies suggests guselkumab is significantly more effective versus ustekinumab for treating psoriasis. Such comparisons can provide useful insights to clinicians and reimbursement decision makers on the relative efficacy of both treatments.