Real-world long-term effectiveness of ustekinumab in ulcerative colitis: results from a spanish open-label cohort

Abstract

Objective

Ustekinumab was recently approved for the treatment of moderate-to-severe ulcerative colitis (UC). Although data from the UNIFI clinical trial are encouraging, real-world data assessing effectiveness and safety are scarce. The aim of this study was to assess the effectiveness, safety and pharmacokinetics of ustekinumab in a large cohort of refractory UC patients.

Methods

Multicenter observational study of UC patients who received ustekinumab for active disease. The Partial Mayo Score (PMS), endoscopic activity, C-reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at different time points. Demographic and clinical data, adverse events (AEs) and surgeries were documented.

Results

A total of 108 patients were analyzed from 4 referral Spanish hospitals. The clinical remission rates were 59%, 56.5%, 57% and 69% of patients at weeks 8, 16, 24 and 52, respectively. Normalization of FC was achieved in 39.6%, 41% and 51% at weeks 8, 24 and 52, respectively. CRP normalization was observed in 79%, 75% and 76.5% of patients at weeks 8, 24 and 52, respectively. Fewer previous anti-TNF agents and loss of response to anti-TNF were associated with clinical response and normalization of FC, respectively. AEs were observed in 5 patients, and 9 underwent colectomy. Ustekinumab persistence rates were 91%, 83% and 81% at 24, 48 and 96 weeks, respectively.

Conclusions

Ustekinumab demonstrated, in the real-world setting, long-term effectiveness and a favorable safety profile in a cohort of refractory UC patients.

Keywords:

• Ustekinumab
• inflammatory bowel disease
• ulcerative colitis
• real-world
• long-term

Acknowledgements

We thank María de Miguel Gallo and Thomas O’Boyle for editorial assistance, and Carlos Fernández for statistical analysis.

Disclosure statement

• Iborra M reports grants and personal fees from MSD, Janssen, Takeda, Kern and Chiesi, during the conduct of the study.

• Ferreiro-Iglesias, R has served as a speaker, advisory member or has received research funding from Takeda, MSD, Abbvie, Janssen, Pfizer, Palex, Shire Pharmaceuticals, TillottsPharma, Faes, Dr. Falk Pharma, Adacyte, Ferring and Casen Recordati.

• Martín-Arranz, MD has received consulting and/or speaker fees from AbbVie, Pfizer, Takeda, Janssen, Tillotts Pharma and Galapagos; and has received research funding from Abbvie, Janssen and Pfizer.

• Mesonero, F has served as a speaker for and received consulting fees from MSD, AbbVie, Takeda, Janssen, Pfizer, Ferring, Kern-Pharma, Dr. Falk Pharma, Galapagos, Chiesi and Faes Farma.

• Mínguez, A has nothing to disclose.

• Porto-Silva, S has nothing to disclose.

• García-Ramírez, L has received financial support for traveling and educational activities or has collaborated with Hoffmann-La Roche, Arena Pharmaceuticals, Sandoz, Ferring Pharmaceuticals.

• García de la Filia, I has nothing to disclose.

• Aguas M has received consulting fees from or performed contracted research or educational activities for Janssen, Abbvie, Tillots and Faes Farma.

• Nieto-García, L has nothing to disclose.

• Suárez Ferrer, C has received funding for training or has collaborated with Abbvie, Takeda, Jannsen, MSD, Tillots Pharma, Pfizer.

• Bastida, G has served as a speaker, consultant, advisory member or has received research funding from, AbbVie Janssen, Kern Pharma, Galapagos, Pfizer, Sandoz, Fresenius, Ferring, Faes Farma and Adacyte.

• Barreiro-De-Acosta, M has served as a speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Takeda, Gilead, Celgene, Pfizer, Fresenius and Adacyte.

• Nos P reports grants and personal fees from MSD, grants from Otsuka, AbbVie; personal fees from Takeda, Kern, Biogen, Ferring.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Additional information

Funding

The author(s) reported there is no funding associated with the work featured in this article.