Real-world data show safety, efficacy of ustekinumab in highly refractory CD patients
Administering ustekinumab at the recommended dose to treat patients with active, moderate-to-severe Crohn’s disease (CD) refractory to various biologics and immunosuppressants in clinical practice appears to be safe and effective, a study has found.
The study included 305 CD patients (median age, 43.7 years; 51 percent female) initiating ustekinumab at 260, 390 or 520 mg based on weight ~6 mg/kg IV at week 0 and at 90 mg subcutaneously at week 8. At baseline, the majority of the population (72 percent) had Harvey‐Bradshaw Index (HBI) of >4 points.
Most patients (64 percent) had received at least two antitumour necrosis factor alpha (anti-TNFα) agents, 87 (29 percent) had received vedolizumab, and 11 were anti‐TNFα-naïve.
Ustekinumab treatment induced clinical remission in 101 patients (47 percent) at week 8 and in 126 (58 percent) at week 14. Faecal calprotectin levels returned to normal (<250 µg/g) in 46 percent and 54 percent of the patients at weeks 8 and 14, respectively. Also, C-reactive protein concentration was normalized (<3 mg/L) in 35 percent and 41 percent of patients at weeks 8 and 14, respectively.
A higher number of previous anti‐TNFα agents and endoscopic severity predicted failure to achieve clinical remission at week 14 (p=0.027 and p=0.004). Neither previous use of vedolizumab nor concomitant use of immunomodulators was associated with response to therapy.
AEs were recorded in 38 patients, and 40 patients were hospitalized. Intolerance to the most recent anti‐TNF agent and fewer previous anti‐TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response.
During the 14‐week follow‐up period, 38 adverse events (AEs) were recorded, most of which were systemic infections and local abscesses. There were 40 patients (13 percent) who had to be admitted to the hospital. Seven cases of hospital admission were attributed to AEs: two due to severe infections (pharyngotonsillitis and Clostridium difficile infection), three due to intestinal obstruction, one due to abdominal septic shock, and the last due to psoas abscesses.