P818 Survival of ustekinumab treatment based on concomitant immunomodulator use

García Ramírez, L.(1)*;Suárez Ferrer, C.(2);Rueda Garcia, J.L.(2);Martín-Arranz, E.(2);Poza Cordón, J.(2);Sánchez-Azofra, M.(2);Martin-Arranz, M.D.(3);

(1)Grupo de enfermedades inmunomediadas gastrointestinales y otras patologías digestivas. Instituto de Investigación Sanitaria del Hospital Universitario La Paz – IdiPAZ- Madrid- España.- Fundación para la Investigación Biomédica- Hospital Universitario La Paz- Madrid- Spain- Madrid- Spain., Gastroenterology, madrid, Spain;(2)Grupo de enfermedades inmunomediadas gastrointestinales y otras patologías digestivas. Instituto de Investigación Sanitaria del Hospital Universitario La Paz – IdiPAZ- Madrid- España.- Gastroenterology Department. Hospital Universitario La Paz- Madrid- Spain- Madrid- Spain., Gastroenterology, Madrid, Spain;(3)Grupo de enfermedades inmunomediadas gastrointestinales y otras patologías digestivas. Instituto de Investigación Sanitaria del Hospital Universitario La Paz – IdiPAZ- Madrid- España.- Gastroenterology Department. Hospital Universitario La Paz- Madrid- Spain. Faculty of Medicine. Universidad Autónoma de Madrid- Madrid- Spain, Gastroenterology, Madrid, Spain;

Background

Given the low immunogenicity of ustekinumab (UST), it has been suggested that it is not necessary to add an immunomodulator (IMM). However, there is little scientific evidence on whether the efficacy of combined UST+IMM treatment may be greater than in monotherapy, due to the concomitant action of both drugs. The aim of the study was to evaluate the survival of UST treatment with and without concomitant IMM.

Methods

Patients with stable follow-up at Hospital Universitario La Paz (Madrid), with Crohn's disease (CD) and previous or current treatment with UST, since May 2016, were retrospectively included.

Results

A total of 137 patients were included. Table 1 shows the baseline characteristics.


In 98 patients (71.53%) UST indication was induction of remission; in 22 (16.06%) post-surgical recurrence treatment; in 5 (3.65%) it was prescribed as post-surgical recurrence prophylaxis; and in the remaining 12 (8.76%) the indication was for other reasons.

At the time of analysis, 91 (66.42%) patients were still on active treatment and 46 (33.58%) had discontinued treatment (of which 9 due to primary failure, 27 due to secondary loss of response, 9 due to adverse events, 1 due to remission).

89 patients (64.96%) did not receive concomitant IMM. Whilst, 48 (35.04%) received concomitant treatment with an IMM. The mean time of IMM treatment was 9.16 years (SD 6.76). 

UST treatment had a mean duration of 2.19 years (SD 1.35) in patients receiving concomitant IMM; while it was of 1.67 years (SD 1.02) in those who did not receive concomitant IMM; being this statistically significant (p=0.0124) (Figure 1). 

 

When performing a multivariate analysis by linear regression, the only variables that negatively influenced UST survival were age at diagnosis (Coef. -0.36; p=0.028), perianal disease (Coef. -0.29; p=0.198) and location rather than L1 (Coef. 0.2; p=0.072). However, concomitant IMM use had a positive influence (Coef. 0.45; p=0.032).


Conclusion

In our experience, the survival of ustekinumab is greater in combined treatment with immunosuppressant, being also the only independent variable associated with a greater durability of the drug.