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Real-world data show safety, efficacy of ustekinumab in highly refractory CD patients

25 Jul 2019

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.

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Most Read Articles
18 Sep 2019
Mortality, length of stay (LOS) and hospital charges are significantly higher in chronic liver disease (CLD) patients with fractures, a recent study has shown. These findings are also associated with increased infection, bleeding and poorer wound healing.
01 Aug 2017
New drug applications approved by US FDA as of 16 - 30 June 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
07 Jun 2019
Gastro-oesophageal reflux disease (GERD) is common among obese patients qualified for bariatric surgery, underscoring the need for preoperative endoscopic assessment, a recent study has shown.
22 Sep 2019
Oral supplementation with the gut commensal bacterium Akkermansia muciniphila safely improves several metabolic parameters in overweight or obese adults, as shown in a proof-of-concept study.