A booster dose of SARS-COV-2 vaccine improves suboptimal seroconversion rates in patients with inflammatory bowel disease. Results of a prospective multicenter study of GETECCU (VACOVEII study).

BACKGROUND: The response to SARS-CoV-2 vaccination decreases in inflammatory bowel disease (IBD) patients, specially under anti-TNF treatment. However, data on medium-term effectiveness are limited, specially using new recommended seroconversion rate (>260BAU/mL). Our aim was to evaluate the 6-month>260 BAU-seroconversion rate after full vaccination and after booster-dose. METHODS: VACOVEII is a Spanish multicenter, prospective study promoted by GETECCU. IBD patients full vaccinated against SARS-CoV-2 and without previous COVID-19 infection, treated or not with immunosuppressants, were included. The booster dose was administered 6 months after the full vaccination. Seroconversion was set at 260BAU/mL, according to most recent recommendations and was assessed 6 months after the full vaccination and 6 months after booster-dose. RESULTS: Between October 2021 and March 2022, 313 patients were included (124 no treatment or mesalazine; 55 immunomodulators; 87 anti-TNF; 19 anti-integrin; and 28 ustekinumab). Most patients received mRNA-vaccines (86%). Six months after full vaccination, overall seroconversion rate was 44.1%, being significantly lower among patients on anti-TNF (19.5%, p<0.001) and ustekinumab (35.7%, p=0.031). The seroconversion rate after booster was 92%. Again, anti-TNF patients had a significantly lower seroconversion rate (67%, p<0.001). mRNA-vaccine improved seroconversion rate (OR 11.720 [95% CI 2.26-60.512]). CONCLUSION: The full vaccination regimen achieves suboptimal response in IBD patients, specially among those anti-TNF or ustekinumab. The booster dose improves seroconversion rate in all patients, although it remains limited in those treated with anti-TNF. These results reinforce the need to prioritize future booster doses in patients on immunosuppressants therapy, specially under anti-TNF, and using mRNA-vaccines.

HLA-DQA1*05 Was Not Associated With Primary Nonresponse or Loss of Response to First Anti-TNF in Real-World Inflammatory Bowel Disease Patients.

BACKGROUND: We lack predictors of response to biologics in the management of patients with inflammatory bowel disease (IBD). A recent study has shown a significant association between HLA-DQA1*05 carriers and the development of loss of response to anti-tumor necrosis factor (TNF) mediated by immunogenicity. METHODS: Retrospective single-center cohort study including IBD patients who had received anti-TNF therapy as a first biologic and whose HLA-DQA1*05 had been determined. Primary nonresponse and secondary failure (assessed by survival analysis) have been evaluated as well as safety outcomes. RESULTS: A total of 199 IBD patients (161 [81%] with Crohn's disease and 38 [19%] with ulcerative colitis) were included. A total of 42.4% were HLA-DQA1*05 carriers and 60% received combination therapy at the start of anti-TNF treatment. Median follow-up was 24 (interquartile range, 11-66) months. No statistically significant differences were found in primary nonresponse to anti-TNF (89.3% vs 87.8%; P = .825), depending on HLA carriers and noncarriers. No differences in secondary loss of response according to HLA variant in any of the analyses performed (full cohort, according to IBD or anti-TNF type) were observed. Again, no differences were observed in patients treated with combination therapy. In terms of safety, no significant differences were found in the rate of infusion reactions or serious adverse events. CONCLUSION: In our real-life cohort of IBD patients treated for the first time with anti-TNF, being an HLA-DQA1*05 carrier did not act as a predictor of response failure, either primary or secondary. The safety of anti-TNF treatment has also not been influenced by the variant.

The HLA variant DQA1*05 has been identified as a risk factor for the development of antibodies to anti-tumor necrosis factor drugs. We observed that its presence has no impact on clinical outcomes, such as secondary loss of response. These data suggest that caution is required before making decisions based on this HLA variant.

Traducción al español y validación de un cuestionario breve de medida del control de la enfermedad inflamatoria intestinal desde la perspectiva del paciente: IBD-Control, EII-Control / Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control

Objetivo: La medida de los resultados percibidos por el paciente en la asistencia de la enfermedad inflamatoria intestinal (EII) adquiere cada vez más importancia. Existe una herramienta sencilla y validada en inglés para este fin: el «IBD-Control». Nuestro objetivo es traducirlo al español, adaptarlo y validarlo.Pacientes y métodos: Se tradujo el IBD-Control, generando el instrumento en español «EII-Control», y se validó prospectivamente. Los pacientes cumplimentaban el EII-Control y otros cuestionarios que servían de comparadores de referencia. El gastroenterólogo realizaba una valoración global de la enfermedad, calculaba índices de actividad y registraba el tratamiento. Un subgrupo de pacientes repitió toda la valoración en una segunda visita. Se analizó también la utilidad de escalas resumidas del EII-Control (el EII-Control-8 y el EII-Control-EVA). Resultados: Se incluyeron 249 pacientes con EII (101 repitieron la segunda visita). Estándares psicométricos del test: consistencia interna: α de Cronbach para EII-Control 0,83 con fuerte correlación entre EII-Control-8 y EII-Control-EVA (r=0,5); reproducibilidad: correlación intraclase 0,70 para EII-Control; validez de constructo: correlaciones de moderadas a fuertes entre EII-Control, EII-Control-8 y EII-Control-EVA frente a comparadores; validez discriminante: p <0,001; sensibilidad al cambio: misma respuesta que índice de calidad de vida. Sensibilidad y especificidad en el punto de corte 14 de 0,696 y 0,903, respectivamente, para determinar el estado quiescente. Conclusiones: El EII-Control es un instrumento válido para medir el control de la EII desde la perspectiva del paciente en nuestro medio y cultura. Su simplicidad lo convierte en una herramienta útil para apoyar la asistencia.(AU)

Objective: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the “IBD-Control”. Our aim is to translate it into Spanish, adapt and validate it. Patients and methods: The IBD-Control was translated into the Spanish instrument “EII-Control” and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. Results: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. Conclusions: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.(AU)

Translation into Spanish and validation of a short questionnaire to measure the control of inflammatory bowel disease from the patient's perspective: IBD-Control, EII-Control. / Traducción al español y validación de un cuestionario breve de medida del control de la enfermedad inflamatoria intestinal desde la perspectiva del paciente: IBD-Control, EII-Control.

OBJECTIVE: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it. PATIENTS AND METHODS: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed. RESULTS: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status. CONCLUSIONS: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care.