Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real‐life experience from two Italian IBD centers

Orlandini, Beatrice; Dragoni, Gabriele; Variola, Angela; Massella, Arianna; Bagnoli, Siro; Campi, Riccardo; Rogai, Francesca

doi:10.1111/1751-2980.12648

Cited by 10 publications

(21 citation statements)

References 19 publications

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“…Regarding colectomy and hospitalisation rates, both were low and similar to those in other real-world studies 27 . Other studies have also found a lower rate of surgery in naive patients 6,18 .…”

Section: Discussionmentioning

confidence: 84%

“…However, at long-term (2 years) biological-naive patients have similar percentages of discontinuation than anti-TNF previously exposed patients 5 . An Italian study, that included 59 UC patients that received golimumab with a mean treatment duration of 52 weeks, neither found differences between naive and experienced patients 18 . This finding has been verified recently 19 .…”

Section: Discussionmentioning

confidence: 93%

“…Data of rheumatic diseases are also controversial. Although some studies have demonstrated higher persistence of golimumab in biologic-naïve patients compared with biologic-experienced patients, other studies did not find statistically significant differences between both groups of patients 15,[17][18][19][20][21][22] .…”

Section: Discussionmentioning

confidence: 99%

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Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Iborra

García-Morales

Rubio

et al. 2020

Sci Rep

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Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

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Section: Discussionmentioning

confidence: 84%

Section: Discussionmentioning

confidence: 93%

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Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Iborra

García-Morales

Rubio

et al. 2020

Sci Rep

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“…Most of these studies were performed at tertiary referral centres and there are few realworld data on long-term outcomes. To the best of our knowledge, only four reports of the 52-week clinical remission rate with golimumab have been published [12][13][14][15] and only one of them gave detailed information on the long-term effect on endoscopic or biochemical activity [14].…”

Section: Introductionmentioning

confidence: 99%

Clinical effectiveness of golimumab in ulcerative colitis: a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG

Eriksson

Visuri

Vigren³

et al. 2021

Scandinavian Journal of Gastroenterology

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“…Our study demonstrates that third-class biologic therapy is a feasible, effective, and safe option in Crohn's disease. It is well established that the number of prior treatments is negatively associated with therapeutic success [29,31,32], and that biologic-naïve patients have a substantially higher likelihood of a response to treatment in inflammatory bowel diseases (IBDs) [17,[33][34][35][36][37]. Until a few years ago, our therapeutic armamentarium in IBD was limited to TNF-alpha inhibitors only, but since then it has expanded to include anti-integrins, IL12/23 blockers, and JAK inhibitors.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Third-Class Biologic Treatment in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

Albshesh

Taylor

Savarino

et al. 2021

JCM

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Background: Multiple studies have described the effectiveness of ustekinumab (UST) and vedolizumab (VDZ) in patients with Crohn’s disease (CD) failing anti- Tumor necrosis factors (TNFs); however, the effectiveness of VDZ or UST as a third-class biologic has not yet been described. Aims and Methods: In this retrospective multicenter cohort study, we aimed to investigate the effectiveness of VDZ and UST as a third-class biologic in patients with CD. Results: Two-hundred and four patients were included; 156/204 (76%) patients received VDZ as a second- and UST as a third-class therapy (group A); the remaining 48/204 (24%) patients received UST as a second- and VDZ as a third-class therapy (group B). At week 16–22, 87/156 (55.5%) patients and 27/48 (56.2%) in groups A and B, respectively, responded to treatment (p = 0.9); 41/156 (26.2%) and 15/48 (31.2%) were in clinical remission (p = 0.5). At week 52; 89/103 (86%) patients and 25/29 (86.2%) of the patients with available data had responded to third-class treatment in groups A and B, respectively (p = 0.9); 31/103 (30%) and 47/29 (24.1%) were in clinical remission (p = 0.5). Conclusion: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were detected between the use of VDZ and UST as a third-class agent.

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Clinical efficacy and safety of golimumab in biologically experienced and naive patients with active ulcerative colitis: A real‐life experience from two Italian IBD centers

Cited by 10 publications

References 19 publications

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients

Clinical effectiveness of golimumab in ulcerative colitis: a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG

Effectiveness of Third-Class Biologic Treatment in Crohn’s Disease: A Multi-Center Retrospective Cohort Study

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