Patients with Crohn’s disease who either lost or had inadequate response to therapy with Stelara were able to recapture that response by having their dosing interval cut in half, according to data presented at the Congress of the European Crohn’s and Colitis Organisation.
“The efficacy of [Stelara; ustekinumab, Janssen] was demonstrated in the UNITI Program,” Mathurin Fumery, MD, PhD, of Amiens University Hospital in France, said during his presentation. “As we can see with anti-TNF, some patients will lose their response. It was observed in about 20% of patients in clinical trials and between 10% to 30% of patients in observational retrospective studies.”
Fumery and colleagues analyzed data from 76 patients with active CD, defined as Crohn’s disease Activity Index > 150 and one objective sign of inflammation (C-reactive protein > 5 mg/L, and/or fecal calprotectin > 250 g/g, and/or radiologic and/or endoscopic evidence of disease activity) to test the efficacy and safety of an escalated dose of ustekinumab 90 mg every 4 weeks — which was previously unknown. All patients required dose escalation from 90 mg every 8 weeks to 90 mg every 4 weeks because of a loss of response or inadequate response.
Patients had their dose optimized after a median of 4.5 months of treatment initiation. Researchers observed a clinical response in 57% of patients after a median of 2.1 months, and after a median follow-up of 8.2 months, 47% of patients were still being treated with ustekinumab, while 26% were in steroid-free remission.
Fumery and colleagues found that colonic location (HR = 4.6; 95% CI, 1.8–8.4), inflammatory behavior (HR = 9.1; 95% CI, 1.2–16.5), and duration of ustekinumab therapy before optimization (HR = 3.2; 1.2–5.4) were associated with clinical response at 2 months.
Investigators identified adverse events in 9% of cases, including one case each of pneumonitis and infectious colitis.
“More than half of patients recaptured response after optimization,” Fumery concluded. – by Alex Young
Reference: Fumery M, et al. Abstract OP24. Presented at: Congress of the European Crohn’s and Colitis Organisation; Mar. 7-9, 2019; Copenhagen.
Disclosure: Fumery reports financial ties to AbbVie, Boehringer, Celgene, Ferring, Janssen, MSD, Pfizer and Takeda. Please see the ECCO disclosure database for all other authors’ relevant financial disclosures.