Guselkumab Induction and SC Maintenance Shows Efficacy and Safety in Crohn’s Disease
Results from the GALAXI-2 and GALAXI-3 pivotal phase 3 trials demonstrate that intravenous induction followed by subcutaneous (SC) maintenance therapy with guselkumab is effective and well tolerated in adults with moderately to severely active Crohn’s disease over 48 weeks.
Both trials showed that guselkumab significantly outperformed placebo across clinical and endoscopic endpoints, with a favorable safety profile.
Conducted at 257 sites across 40 countries, these randomized, double-blind, placebo- and active-controlled studies evaluated two guselkumab dosing regimens versus ustekinumab and placebo. A total of 1048 participants were randomized, with 1021 included in the primary analysis. Patients received either 200 mg intravenous guselkumab at weeks 0, 4, and 8 followed by 200 mg subcutaneous every 4 weeks, 100 mg subcutaneous every 8 weeks, ustekinumab per approved dosing, or placebo. Primary composite endpoints included clinical response at week 12 followed by either clinical remission or endoscopic response at week 48.
In both trials, guselkumab significantly surpassed placebo for both composite endpoints. In GALAXI-2, clinical response at week 12 with clinical remission at week 48 was achieved in 55% of the 200 mg group and 49% of the 100 mg group, versus 12% in the placebo arm (p<0.0001). Similarly, in GALAXI-3, 48% and 47% achieved this outcome in the respective guselkumab groups versus 13% on placebo (p<0.0001). Endoscopic response followed a comparable pattern, with both guselkumab regimens demonstrating significant superiority over placebo in both trials.
Safety data revealed lower rates of serious adverse events in guselkumab-treated patients (7%–11%) compared with ustekinumab (12%) and placebo (15%). No deaths occurred.
Reference:
Panaccione R, Feagan BG, Afzali A, et al. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.
