Abstract

Abstract Background With the usual subcutaneous (SC) doses (90 mg every 8-12 weeks) of Ustekinumab some patients will only partially respond or experience secondary loss of response. Intravenous (IV) dose of Ustekinumab is more affordable than the subcutaneous does in China. However, the evidence of intravenous administration maintenance when shortening subcutaneous dose is not effective enough is limited. Methods We conducted a retrospective study to evaluate the effectiveness and safety of IV Ustekinumab in patients with Crohn´s disease (CD). Patients received Ustekinumab with insufficient efficacy or loss of response to 90 mg SC treatment could escalate to IV maintenance at regular intervals through every clinic visit and could deescalate back to SC maintenance when the efficacy is satisfied. We obtained data from 247 patients. Results Follow-up data beyond 24 weeks (24w) were available for 229 patients and data beyond 52 weeks (52w) were available for 144. Baseline characteristics of the included patients are shown in Table 1. Complicated forms (B2-B3; 55.6%) predominated and perianal disease was present in 45.3% of patients. 136(58.12%) patients were naïve to biological treatments, 41.8% had received at one and 8.97% more than 2. Steroid-free clinical remission were observed in 88.1%(185/210) patients at 24 weeks.35/104(33.65%) had a normal level of fecal calprotectin(FCP) and 56/115(48.70%) achieved endoscopic remission at 52 weeks. Serious adverse events were reported in 0.81% of patients. Logistic regression demonstrated that 24w C-reactive protein, baseline FCP and frequency of IV treatment were associated with endoscopic remission at 52w (Figure 1). Conclusion Patients who lose response to the intensified dose of Ustekinumab SC could benefit from intravenous administration as maintenance treatment.

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