P737 Ustekinumab induction effectiveness in Crohn’s disease in a real-life cohort

E. Sánchez Rodríguez, F. Mesonero Gismero, A. López sanroman

Hospital Universitario Ramón y Cajal, Servicio de Gastroenterología y Hepatología, Madrid, Spain

Background

Evaluation of Ustekinumab induction therapy is generally performed at week 16. Our aim was to evaluate if a delayed response may be expected beyond that time.

Methods

Retrospective study including patients with CD who received Ustekinumab since 1 June 2017 to 1 May 2019. Iv induction dose was based on weight while maintenance was conducted with 90 mg subcutaneous every 8 weeks.

Results

Twenty-five patients (52% male) were enrolled, of whom 28% (7/25) had ileal, 28(7/25) colonic, 44% (11/25) ileocolonic and 8% (2/25) upper tract involvement. Sixty-eight per cent (17/25) presented an inflammatory, 16% (4/25) a stricturing and 16% (4/25) a penetrating behaviour. Perianal disease was diagnosed in 20% of patients (5/25). All patients 100% (25/25) had previously taken immunosuppressants and 96% (24/25) biological therapy (mean 1.8 ± 0.87 (0–3) per patient): 36% (9/25) one, 36% (9/25) two and 24% (6/25) three agents. Ustekinumab was prescribed for achieving remission in 92% (23/25) of the patients, fistulising disease in 4% (1/25) and for maintenance of remission in the same percentage. Follow-up was 373.16 ± 182.53(59–683) days. Discontinuation rate was 24% (6/25), due to primary failure in 100% (6/6). For those who stopped the drug, average treatment time was 137.17 ± 95.11(61–1320) days whereas that of those who continued was 346.84 ± 192.10(32–669) days. Clinical response was evaluated at week 8, week 14–16, week 22–24 and during long-term maintenance (Table 1). All comparisons were statistically significant (p < 0.05). We recorded Harvey-Bradshaw index(H-B), CRP and faecal calprotectin (FC) before induction with ustekinumab, at weeks 14–16, at weeks 22–24 and during maintenance. Results are presented in Table 2.

Table 1.
Week 8 (N = 25)Steroid free remission:24% (6); Remission with steroids: 40% (10); Clinical response: 16% (4/25); Primary non response: 20% (5/25)
Weeks 14–16 (N = 24)Steroid free remission: 29.2% (7); Remission with steroids: 37.5% (9); Clinical response: 16.7% (4); Primary non response: 16.7% (4)
Weeks 22–24 (N = 21)Steroid free remission: 61.9% (13); Remission with steroids: 19% (4); Clinical response: 14.3% (3); Primary non response: 16.7% (4)
Maintenance (N = 18)Steroid free remission: 88.9% (16); Remission with steroids: 11.1% (2)
Table 2.
Before inductionWeeks 14–16Weeks 22–24Maintenance
CRP20.57 ± 24.25 (3.2–93)11.03 ± 12.38 (0.7–52)10.84 ± 13.97 (0.2–50)6.17 ± 0.73 (0.6–34)
FC648.25 ± 709.10 (86–2295)167 ± 80.60 (135–210)145.5 ± 133.06 (45–334)270 ± 309.14 (7–629)
H-B7 ± 4.52 (0–20)4 ± 4.43 (0–20)2 ± 3 (0–11)1 ± 2 (0–9)

Conclusion

Evaluation of induction effectiveness at week 22–24 may allow to rescue those patients who present a delayed response to UST. During a 373.16 days follow-up, loss of response to Ustekinumab is low.