Early Assessment of Ustekinumab for Crohnʼs Disease: A Chart Review

Abstract

Introduction: Ustekinumab is the only biologic targeting two inflammatory cytokines, IL-12 and IL-23, that is FDA approved for the treatment of Crohn's Disease (CD) pathophysiology. A retrospective chart review was conducted to provide an early assessment of the demographic and disease characteristics of CD patients treated with ustekinumab. Methods: Patient charts at ustekinumab therapy initiation (index) were obtained from GI practices in the US. The review period was for a max of 3 years prior to index. Inclusion criteria: Primary diagnosis of CD Treatment initiation after FDA approval (9/26/2016) ≥ 18 years at index Exclusion criteria: Pregnancy Use to primarily treat: Psoriatic arthritis Psoriasis Ulcerative colitis Demographics included age, gender, ethnicity, insurance. Disease characteristics included CD related complications, surgeries, prior and current CD medications, length of disease duration and lab values. Results: Evaluation of 63 charts revealed that patients were mostly female (62%) and Caucasian (59%). The mean age was 43.6 ± 14.5 years. Mean disease duration was 9.55 ± 10.54 years. Most patients (84%) were bio-experienced. Eighty one percent of patients were on a steroid prior to index, while 7.5% had a prescription for a steroid after index. In the sample, 46% of patients had at least one, and 24% had at least two different pre-existing comorbidities prior to therapy including hypertension (23%), depression (15%), and anxiety (15%). Just over half of patients (52%) had a CD related complication prior to index including bowel obstruction (29%), fistula (27%), and anal fissure (19%). Of the CD-related surgeries observed, nearly 54% were for resections/removals (e.g. colectomy) and 28% were for repairs/creations (e.g., Ileostomy). Fifty one percent of hospitalizations were related to a CD flare or abdominal pain prior to index. Prior to initiating therapy, Erythrocyte Sedimentation Rate (ESR) values were normal (mean: 21.96 ± 17.07 mm/hr) while C-reactive protein (CRP) values were elevated (mean: 11.15 ± 11.62 mg/dL). Conclusion: This study is an early assessment of the characteristics of CD patients at ustekinumab initiation. These patients are complex, with a variety of comorbidities, complications and hospitalizations not addressed by previous therapies, which may have led to the decision to initiate on ustekinumab. Chart data obtained at 6 months should provide additional detail about the level of disease activity and overall patient trajectory.