P593 Ustekinumab for the treatment of perianal Crohn’s disease. A real-world experience in a Spanish hospital

Algara San Nicolas, M.(1);Masedo Gonzalez, A.(1);Gomez Gomez, G.J.(1);Yela San Bernardino, C.(1);Casis Herce, B.(1);Martinez Montiel, M.P.(1);

(1)Hospital 12 de Octubre, Gastroenterology, Madrid, Spain


Perianal Crohn’s disease (pCD) is difficult to treat. Although anti-TNF, are the medical mainstay in fistula treatment, many patients become refractory. Recent data suggested that ustekinumab (UST) might be effective in pCD.  

This study aims to assess the effectiveness of UST in refractory pCD in the real-world practice.


This is a retrospective cohort of patients with pCD treated with UST in our IBD Unit between march 2015 and october 2020. We analyze demographics, disease charactersistics, surgical for pCD and prior exposure including inmunomodulators and biologic agents. The success of UST was defined on the physician judgment (improvement or absence of drainage). In patients with inactive pCD we analyzed rate of relapse. To analyze predictive factors of treatment success we performed a univariate and multivariable analysis.


Fifty three patients were included (54.72 % female). Twenty four of them were smokers. The median age was 54 years (45-62). The mean duration of CD was 19 years and 50.94% had an intestinal resection. Fifty one patients (96,22%) had been treated with at least 1 anti-TNF and 38 (71.7%) with at least 2 anti-TNF. Sixteen had failed to vedolizumab.  

The median follow-up was 26 months (15-36). Twenty two (22/53) had active pCD.  Eleven (50%) had intensified UST out of technical sheet (8 with 90 mg sc every 4 to 6 w, and 3 had 130 mg iv every 4 w).  Fifteen patients (68.18 %; p<0.001) had clinical improvement after started UST, 10/22 (45.45%; p <0.001) radiological improvement and no one of them require other treatment (p < 0.006). In multivariable analysis, no factors were associated with clinical or radiological improvement.

Two of 32 patients (6.45%) with inactive pCD relapsed during the follow-up.

Eleven patients (20.75%) discontinued UST: 6/53 (11.3%) due to adverse events (infections and arthralgia), 4/53 (7,54) patient´s choice or physician judment.  One patient who had been treated with four biologics before UST developed a pleomorphic cutaneous sarcoma


Ustekinumab might by an effective treatment in refractory   pCD. More studies are needed to confirm our data