Stelara shows efficacy in real-world study
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After 52 weeks of treatment, Stelara helped induce clinical and endoscopic remission in patients with refractory Crohn’s disease, according to study results.
Marisa Iborra, MD, PhD, from Hospital Universitari Politecnic La Fe in Spain, and colleagues wrote that there is little research on the long-term safety and efficacy of Stelara (ustekinumab, Janssen), using data taken from daily clinical practice.
“Although these studies confirm the effectiveness and safety of ustekinumab in CD patients refractory to many treatments, the number of patients analyzed in the long-term follow-up is small, many data are unavailable, and the predictors of clinical response require further investigation,” they wrote.
Researchers conducted a multicenter study comprising 407 patients with CD who started at the recommended dose of ustekinumab and followed them for 1 year. They assessed values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein, and fecal calprotectin at baseline and at weeks 26 and 52. They also documented adverse events and patient data on previous treatments.
In the study group, 56 patients (14%) received the initial maintenance dose of 90 mg subcutaneously every 12 weeks, 347 patients (85%) received it every 8 weeks and 4 patients (1%) received it every 4 weeks.
Of the 295 patients who had an HBI score greater than 4 at baseline, 169 (57%) achieved clinical remission at week 26 and 190 achieved it at week 52 (64%). Fecal calprotectin levels returned to normal at week 26 in 44% of patients and at week 52 in 54% of patients, while 36% and 37% of patients achieved normal CRP levels by weeks 26 and 52, respectively.
Researchers found that 60 patients experienced adverse events.
In their analysis, Iborra and colleagues found that the use of fewer previous anti-TNF agents and ileal localization were associated with clinical remission, and endoscopic severity was associated with poor response.
“Our results show the effectiveness and safety of the drug, especially in patients who had received fewer previous [anti-TNF alpha] agents, thus suggesting the benefits of early administration of the drug in patients with primary failure or contraindication to [anti-TNF alpha] agents and with no need of concomitant immunosuppressants,” they wrote. “We hypothesize that, in the case of higher baseline inflammatory load and a higher number of previous anti-TNF alpha agents, we should consider higher initial doses, accelerated induction regimens and reinduction. Prospective studies are necessary to clarify these recommendations and to evaluate the pharmacokinetics of ustekinumab.”
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