Early Assessment of Ustekinumab for Crohn’s Disease: A Chart Review

BACKGROUND: Ustekinumab was approved by the FDA in September 2016 for the treatment of patients with moderate-to-severe Crohn’s Disease (CD). Little is published about either the health and treatment history of patients prescribed ustekinumab in real-world clinical practice or about the treatment decision-making process.

METHODS: This is a report on a retrospective chart review of 63 adult patients recently initiating therapy with ustekinumab for the treatment of CD.  Charts were selected from independent GI practices in the United States. A structured case report form was used to abstract data on patient demographics, disease characteristics (complications, surgeries, medications, disease duration), and clinical laboratory assessments. The review period was limited to 3 years retrospectively.

RESULTS: The mean chart review period was 2.5 ± 0.8 years. The patient population was 62% female.  At ustekinumab initiation, the median age was 43 years (range, 20-68) and the mean disease duration was 9.6 ± 10.5 years (range, 0-49). Most patients (90.5%) had any history of steroid therapy. History of complications from CD were common, occurring in 52.4% of patients; most common were bowel obstruction (29%), fistula (27%), and anal fissure (19%). Thirteen patients (20.6%) reported a CD-related surgery, mostly bowel resections, during the chart review period. Eighteen (28.6%) patients had at least one hospitalization in the prior year, and 5 (7.9%) patients had two or more in the prior year, with nearly 50% of the hospitalizations related to a CD flare.

Upon starting treatment with ustekinumab, CRP values were elevated (mean: 11.15 ± 11.62 mg/dL).   Most (50/63, or 79.4%) of the cohort had already been treated with a biologic, including 60% (30/50) who had failed 2 or more therapies. Fifty percent of bio-experienced patients switched from adalimumab, 22% from infliximab, 18% from certolizumab, and 8% from vedolizumab. The most common reasons bio-experienced patients switched to ustekinumab were primary non-response (22.2%), secondary loss of response (20.6%), and side effects (14.3%). Among the 20.6% of the population that was bio-naïve, the most common single reason documented by prescribers for initiating therapy with ustekinumab was a desire to minimize infectious complications.  Patient choice was the next most common reason, although some cases did not list a reason at all. 

CONCLUSION(S): The vast majority (79.4%) of our cohort was bio-experienced prior to switching treatment to ustekinumab.  The most common reasons for switching to ustekinumab related to treatment failure with the previous biologic (primary/secondary non-response) or side effects.  About 20% of our cohort was bio-naïve prior to starting treatment with ustekinumab.  The single most common reason to start with ustekinumab was minimizing risk of infection followed by patient choice.  As we prospectively follow this group, we expect that clinical assessments 6 months following treatment initiation will reveal additional insights into the effectiveness of ustekinumab in bio-naïve versus bio experienced patients.