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Observational Study
. 2021 Feb;9(1):102-109.
doi: 10.1177/2050640620974308. Epub 2021 Mar 1.

Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

Daniela Pugliese  1 , Giuseppe Privitera  2 , Francesca Rogai  3 , Angela Variola  4 , Anna Viola  5 , Lucrezia Laterza  1 , Antonino C Privitera  6 , Mariangela Allocca  7 , Fabrizio Bossa  8 , Maria Cappello  9 , Marco Daperno  10 , Greta Lorenzon  11 , Silvia Mazzuoli  12 , Mariabeatrice Principi  13 , Renato Sablich  14 , Luisa Moser  15 , Antonio Ferronato  16 , Sara Traini  17 , Gherardo Tapete  18 , Giorgia Bodini  19 , Maria Di Girolamo  20 , Laurino Grossi  21 , Giammarco Mocci  22 , Chiara Ricci  23 , Simone Saibeni  24 , Stefano Festa  25 , Rocco Spagnuolo  26 , Claudio C Cortelezzi  27 , Filippo Mocciaro  28 , Fernando Rizzello  29 , Alessandro Armuzzi  1   2 ; Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)
Affiliations
Observational Study

Two-year effectiveness and safety of golimumab in ulcerative colitis: An IG-IBD study

Daniela Pugliese et al. United European Gastroenterol J. 2021 Feb.

Abstract

Background: Few data exist regarding the long-term effectiveness of golimumab in ulcerative colitis. No data have been reported on real-world continuous clinical response.

Objective: This study aimed to describe the long-term outcomes in a large cohort of patients on golimumab who had ulcerative colitis.

Methods: Consecutive patients with active ulcerative colitis, started on golimumab, were enrolled and prospectively followed up. The primary end point was to evaluate the long-term persistence on golimumab therapy.

Results: A total of 173 patients with ulcerative colitis were studied. Of these, 79.2% were steroid dependent, and 46.3% were naïve to anti-tumour necrosis factor alpha agents. The median duration of golimumab therapy was 52 weeks (range: 4-142 weeks). The cumulative probability of maintaining golimumab treatment was 47.3% and 22.5% at 54 and 108 weeks, respectively. Biological-naïve status (odds ratio [OR] = 3.02, 95% confidence interval [CI]: 1.44-6.29; p = 0.003) and being able to discontinue steroids at Week 8 (OR = 3.32, 95% CI: 1.34-8.30; p = 0.010) and Week 14 (OR = 2.94, 95% CI: 1.08-8.02; p = 0.036) were associated with longer persistence on therapy. At Week 54, 65/124 (52.4%) postinduction responders were in continuous clinical response. A continuous clinical response was associated with a lower likelihood of golimumab discontinuation throughout the subsequent year of therapy (p < 0.01). Overall, 40 (23.1%) patients were in clinical remission at the last follow-up visit. Twenty-six adverse events were recorded, leading to golimumab withdrawal in 9.2% of patients.

Conclusions: Biological-naïve status and not requiring steroids at Weeks 8 and 14 seem to be associated with a longer persistence on golimumab therapy in ulcerative colitis.

Keywords: golimumab; naïve; persistence; remission; ulcerative colitis.

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Conflict of interest statement

The authors declare the following conflicts of interest: Daniela Pugliese received speaker fees from AbbVie, MSD, Takeda, Janssen and Pfeizer. Giuseppe Privitera received consultancies fees from Alphasigma. Mariangela Allocca received consulting fees from Nikkiso Europe and lecture fees from Janssen, Abbvie and Pfizer. Maria Cappello served as an advisory board member for AbbVie, MSD and Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi and Takeda Pharmaceuticals. Marco Daperno received lectures, board and/or congress fees from Abbvie, Pfizer, Takeda, Mundipharma, Janssen, MS&D, SOFAR, Ferring and Chiesi. Maria Di Girolamo received speaker fees from Abbvie. Fernando Rizzello acted as consultant for Janssen, Abbvie, Takeda, MSD and Amgen, and participated in a speaker's bureau sponsored by Abbvie, Janssen, Takeda, Ferring, MSD, Sofar and Chiesi. Alessandro Armuzzi received consulting and/or advisory board fees from AbbVie, Allergan, Amgen, Biogen, Bristol‐Myers Squibb, Celgene, Celltrion, Ferring, Janssen, Lilly, MSD, Mylan, Pfizer, Samsung Bioepis, Sandoz and Takeda; lecture and/or speaker bureau fees from AbbVie, Amgen, Biogen, Ferring, Janssen, MSD, Mitsubishi‐Tanabe, Nikkiso, Pfizer, Sandoz, Samsung Bioepis and Takeda; and research grants from MSD, Pfizer and Takeda. All the other authors have no conflict of interest to declare.

Figures

FIGURE 1
FIGURE 1
Cumulative probability of maintaining golimumab treatment
FIGURE 2
FIGURE 2
Cumulative probability of maintaining golimumab treatment. Patients split between those who were anti‐tumour necrosis factor (TNF) alpha naïve and those who were anti‐TNF alpha experienced
See this image and copyright information in PMC

References

    1. Dignass A, Eliakim R, Magro F, et al. Second European evidence‐based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis. J Crohns Colitis. 2012;6:965–90. - PubMed
    1. European Medicines Agency . Simponi®; 2020. https://www.ema.europa.eu/en/documents/product-information/simponiepar-p.... Accessed 13 July 2020.
    1. Food and Drug Administration . Simponi®; 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125289s006lbl.pdf. Accessed 13 July 2020.
    1. Sandborn WJ, Feagan BG, Marano C, et al. Sub‐cutaneous golimumab induces clinical response and remission in patients with moderate‐to‐severe ulcerative colitis. Gastroenterology. 2014;146:85–95. - PubMed
    1. Sandborn WJ, Feagan BG, Marano C, et al. Subcutaneous golimumab maintains clinical response in patients with moderate‐to‐severe ulcerative colitis. Gastroenterology. 2014;146:96–109.e1. - PubMed

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