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

Bossa, Fabrizio; Biscaglia, Giuseppe; Valvano, Maria Rosa; Costantino, Giuseppe; Lauria, Angelo; Clemente, R.; Ferracane, Concetta; Shahini, Endrit; Mendolaro, M.; Grossi, Laurino; Mazzuoli, S.; Rispo, Antonio; Pranzo, Giuseppe; Sebkova, Ladislava; Tursi, Antonio; Miranda, Agnese; Patturelli, Marta; Spagnuolo, Rocco; Ricciardelli, C.; Sgarro, C.; Paese, Pietro; Inserra, G.; Azzarone, Alessandro; Nardone, Olga Maria; Fries, Walter; Buccianti, N.; Privitera, Antonino Carlo; Principi, M.B.; Cappello, Maria; Guglielmi, Francesco William; Romano, Marco; Riegler, G.; Fanigliulo, L.; Melina, Raffaele; Andriulli, Angelo

doi:10.1007/s10620-019-05904-z

Cited by 12 publications

(35 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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 . Data of rheumatic diseases are also controversial.…”

Section: Discussionsupporting

confidence: 74%

See 1 more Smart Citation

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

Iborra

García-Morales

Rubio

et al. 2020

Sci Rep

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 74%

“…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%

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

Iborra

García-Morales

Rubio

et al. 2020

Sci Rep

View full text Add to dashboard Cite

show abstract

“…Finally, the overall safety profile of golimumab was confirmed to be good, consistent with those reported in other real‐life experiences and of other anti‐TNF‐alpha drugs 8 ,. 12 , 16 No new safety concerns about golimumab emerged during our two years of follow‐up.…”

Section: Discussionmentioning

confidence: 98%

“…Long‐term open‐label follow‐up confirmed a good profile of effectiveness up to 4 years, more evident among patients with CCR at 54 weeks 6 ,. 7 To date, few long‐term real‐life data have been reported, showing highly variable persistence on golimumab therapy in some cohorts, and particularly reduced in patients pluri‐exposed to anti‐tumour necrosis factor alpha (TNF‐α) drugs and treated with the fixed dose of 50 mg during maintenance therapy 8‐12 …”

Section: Introductionmentioning

confidence: 99%

“…6,7 To date, few long-term real-life data have been reported, showing highly variable persistence on golimumab therapy in some cohorts, and particularly reduced in patients pluri-exposed to anti-tumour necrosis factor alpha (TNF-α) drugs and treated with the fixed dose of 50 mg during maintenance therapy. [8][9][10][11][12] The aims of this study were to investigate the mid-and long-term outcomes of patients with UC treated with golimumab in real life and to explore potential predictors for these outcomes.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

et al. 2021

Self Cite

View full text Add to dashboard Cite

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%) post-induction 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.

show abstract

Golimumab improves health-related quality of life of patients with moderate-to-severe ulcerative colitis: Results of the go-care study

Saibeni,

Bezzio,

Bossa

et al. 2024

Digestive and Liver Disease

View full text Add to dashboard Cite

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

Cited by 12 publications

References 16 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

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

Golimumab improves health-related quality of life of patients with moderate-to-severe ulcerative colitis: Results of the go-care study

Contact Info

Product

Resources

About