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Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis

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Abstract

Background

Golimumab is a new anti-TNF-alpha monoclonal antibody for patients with ulcerative colitis.

Aims

To assess the short- and long-term effectiveness and safety of golimumab in daily clinical practice and to identify predictors of response.

Methods

Consecutive patients treated with golimumab in 22 Italian centers were enrolled. Clinical, laboratory, and endoscopic data were prospectively collected before and during treatment. A subgroup of patients completed a questionnaire to assess personal satisfaction with a golimumab autoinjector system.

Results

A total of 196 patients were included. After 3 months, 130 patients were responders (66.3%) and showed significant reductions in mean partial, total, and endoscopic Mayo scores and in mean ESR, C-reactive protein, and fecal calprotectin levels (p < 0.001). Multivariate analysis revealed that a higher total Mayo score (p < 0.001, OR 1.5, 95% CI 1.2–1.8) and naïve status to anti-TNF-alpha (p = 0.015, OR 3.0, 95% CI 1.2–7.5) were predictive of a favorable response. Seventy-seven (39.3%) of the 130 responders maintained a response at month 12 of therapy. There were 17 adverse events, 28 patients needed hospitalization, and 15 patients underwent surgery. Self-administration of the drug was appreciated by most patients.

Conclusions

The efficacy and safety of golimumab in daily clinical practice were confirmed for the short- and long-term treatment of patients with active ulcerative colitis. Patients naïve to the anti-TNF-alpha monoclonal antibody and those with a higher total Mayo score were more likely to respond to golimumab.

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Funding

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Authors and Affiliations

  1. Gastroenterology Division, Fondazione Casa Sollievo della Sofferenza IRCCS, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, Italy

    Fabrizio Bossa, Giuseppe Biscaglia, Maria Rosa Valvano & Angelo Andriulli

  2. Clinical Unit for Chronic Bowel Disorders, University of Messina, Messina, Italy

    Giuseppe Costantino & Walter Fries

  3. Grande Ospedale Metropolitano Reggio Calabria, Reggio Calabria, Italy

    Angelo Lauria

  4. UOC di Medicina Generale, Ospedale Madonna delle Grazie, Matera, Italy

    Rocco Clemente & Nello Buccianti

  5. IBD Unit Azienda Ospedaliera per l’Emergenza “Cannizzaro”, Catania, Italy

    Concetta Ferracane & Antonino Carlo Privitera

  6. Emergency and Organ Transplantation Department, Section of Gastroenterology, AOU Policlinico, Bari, Italy

    Endrit Shahini & Maria Beatrice Principi

  7. Gastroenterology and Hepatology Section, DIBIMIS, University of Palermo School of Medicine, Palermo, Italy

    Marco Mendolaro & Maria Cappello

  8. Gastroenterology Unit, University of Pescara, Pescara, Italy

    Laurino Grossi

  9. Gastroenterology and Artificial Nutrition Department, “San Nicola Pellegrino” Hospital, Trani, Italy

    Silvia Mazzuoli & Francesco William Guglielmi

  10. Clinical Medicine and Surgery Department, Section of Gastroenterology, University “Federico II” of Naples, Naples, Italy

    Antonio Rispo & Olga Nardone

  11. Surgery Unit, Valle D’Itria Hospital, Martina Franca, Italy

    Giuseppe Pranzo

  12. Gastroenterology Unit, Pugliese Ciaccio Hospital, Catanzaro, Italy

    Ladislava Sebkova

  13. Gastroenterology Service, ASL BAT, Andria, Italy

    Antonio Tursi

  14. “F. Magrassi” Clinical and Experimental Medicine Department, Università della Campania “Luigi Vanvitelli”, Naples, Italy

    Agnese Miranda & Marco Romano

  15. UOSD Gastroenterologia, Università della Campania “Luigi Vanvitelli”, Naples, Italy

    Marta Patturelli & Gabriele Riegler

  16. Gastroenterology and Digestive Endoscopy Department, University of Catanzaro, Catanzaro, Italy

    Rocco Spagnuolo

  17. Gastroenterology Unit, Poggiardo Hospital, Poggiardo, Italy

    Cristina Ricciardelli

  18. Gastroenterology and Digestive Endoscopy Unit, OORR, Foggia, Italy

    Caterina Sgarro

  19. Gastroenterology Unit, Ospedale Annunziata, Cosenza, Italy

    Pietro Paese

  20. Internal Medicine, Medical and Pediatric Sciences Department, University of Catania, Catania, Italy

    Gaetano Inserra

  21. Gastroenterology Unit, Ospedale San Paolo, Bari, Italy

    Alessandro Azzarone

  22. Gastroenterology Unit, Ospedale Santissima Annunziata, Taranto, Italy

    Libera Fanigliulo

  23. Gastroenterology Unit, Ospedale San Giuseppe Moscati, Avellino, Italy

    Raffaele Melina

Authors
  1. Fabrizio Bossa
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  2. Giuseppe Biscaglia
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  3. Maria Rosa Valvano
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  4. Giuseppe Costantino
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  5. Angelo Lauria
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  6. Rocco Clemente
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  7. Concetta Ferracane
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  8. Endrit Shahini
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  9. Marco Mendolaro
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  10. Laurino Grossi
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  11. Silvia Mazzuoli
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  12. Antonio Rispo
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  13. Giuseppe Pranzo
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  14. Ladislava Sebkova
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  15. Antonio Tursi
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  16. Agnese Miranda
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  17. Marta Patturelli
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  18. Rocco Spagnuolo
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  19. Cristina Ricciardelli
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  20. Caterina Sgarro
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  21. Pietro Paese
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  22. Gaetano Inserra
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  23. Alessandro Azzarone
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  24. Olga Nardone
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  25. Walter Fries
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  26. Nello Buccianti
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  27. Antonino Carlo Privitera
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  28. Maria Beatrice Principi
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  29. Maria Cappello
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  30. Francesco William Guglielmi
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  31. Marco Romano
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  32. Gabriele Riegler
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  33. Libera Fanigliulo
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  34. Raffaele Melina
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  35. Angelo Andriulli
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Contributions

FB: planning the study, drafting the article, analysis and interpretation of data. AA, GB, FWG, AR, MBP, MC, AT, WF, ACP, GC, LG, and SM: planning the study, critical revision of the article and interpretation of data. MRV: analysis of data. AL, RC, CF, ES, MM, GP, LS, AM, MP, RS, CR, CS, PP, GI, AAz, ON, NB, MR, GR, LF, and RM: critical revision of the article for important intellectual content.

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Correspondence to Fabrizio Bossa.

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Bossa, F., Biscaglia, G., Valvano, M.R. et al. Real-Life Effectiveness and Safety of Golimumab and Its Predictors of Response in Patients with Ulcerative Colitis. Dig Dis Sci 65, 1767–1776 (2020). https://doi.org/10.1007/s10620-019-05904-z

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  • DOI: https://doi.org/10.1007/s10620-019-05904-z

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