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

Eriksson, Carl; Visuri, Isabella; Vigren, Lina; Nilsson, Linda; Kärnell, Anders; Hjortswang, Henrik; Bergemalm, Daniel; Almér, Sven; Hertervig, Erik; Karlén, Per; Strid, Hans; Halfvarson, Jonas

doi:10.1080/00365521.2021.1963466

Cited by 8 publications

(16 citation statements)

References 41 publications

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“…The 52-week remission rate in our study was similar or slightly higher than those reported in recent studies [ 18 , 20 , 31 ]. The phase 4 GO-COLITIS study demonstrated a 25.4% clinical remission at week 54 in 205 anti-TNF-α naive UC patients [ 20 ].…”

Section: Discussionsupporting

confidence: 88%

“…Although the efficacy and safety of GLM in biologic-naive patients with refractory UC were well established from randomised clinical trials [ 8 , 9 , 10 ], real-life data remained sparse. Most observational studies have been limited by a short follow-up [ 22 , 23 , 24 ], mainly biologic-naive population [ 20 , 21 ], and small sample size [ 18 , 19 ]. Here, we confirmed the real-world effectiveness and safety of GLM for UC patients based on PMS in Japan.…”

Section: Discussionmentioning

confidence: 99%

“…The phase 4 GO-COLITIS study demonstrated a 25.4% clinical remission at week 54 in 205 anti-TNF-α naive UC patients [ 20 ]. In the prospective multicentre SWIBREG study, the 52-week remission rate by total Mayo scores was 20% among 50 patients with UC, including 70% of TNF-exposed participants [ 18 ]. Moreover, Olivera et al [ 31 ] reported a pooled clinical remission rate, including initial GLM responders, of 39.2% according to the results of eight observational studies (822 patients, 24–54 weeks).…”

Section: Discussionmentioning

confidence: 99%

“…Several observational studies on patients treated with GLM have recently been published [ 16 , 17 ]. However, most have included a limited sample size [ 18 , 19 ], mainly biologic-naive population [ 20 , 21 ], or short follow-up period [ 22 , 23 , 24 ]. Moreover, early clinical indicators for 1-year outcomes of GLM treatment have not been identified.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan

Nakamura

Asano²,

Tanaka³

et al. 2022

Inflamm Intest Dis

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Introduction: Real-world evidence for the effectiveness and safety of golimumab (GLM) in patients with ulcerative colitis (UC) is limited. The aim of this study was to investigate the 52-week effectiveness and safety of GLM treatment for UC. Methods: This prospective, multicentre, post-marketing surveillance study is conducted in 393 patients with UC in Japan (UMIN000027542). Clinical remission (partial Mayo score ≤2), adverse drug reactions (ADRs) and their predictors, and treatment persistence were analysed. Results: The safety analysis sets comprised 391 patients. Patients in clinical remission at baseline were excluded, and 336 were used for effectiveness analysis. Clinical remission was 47.9%, 48.5%, 44.6%, and 39.6% at weeks 6, 22, 36, and 52, respectively, in the intent-to-treat analysis. In biologic-naïve patients, clinical remission was slightly higher than that in biologic-experienced patients. At week 52, patients who concomitantly used corticosteroids at baseline showed numerically lower clinical remission rates than non-users of corticosteroids (34.9% vs 44.5%). Multivariate analysis showed that smoking history (P=0.040, odds ratio [OR]=1.911, 95% confidence interval [CI] 1.030–3.546) was an independent factor associated with clinical remission at week 52. ADRs occurred in 71 patients (18.2%) and included 9 cases of rash. Serious ADRs occurred in 40 patients (10.2%), including 8 cases of UC exacerbation. Additionally, the presence of comorbidities was associated with ADR incidence (P=0.010, OR=2.000, 95% CI 1.183–3.380). Conclusion: The real-world effectiveness of GLM treatment was confirmed in biologic-naïve and -experienced populations. The safety profile of GLM treatment was consistent with previous findings.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan

Nakamura

Asano²,

Tanaka³

et al. 2022

Inflamm Intest Dis

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“…Adalimumab was also quite commonly used as the first-line biological in CD. In line with the earlier data, golimumab and ustekinumab were typically used as second-or third-line treatments [26][27][28]. Since 2018, reimbursed subcutaneous formulations for infliximab and vedolizumab as well as tofacitinib have become available, which will be included in a future study focusing on drug switches.…”

Section: Discussionmentioning

confidence: 82%

Dose–escalation of adalimumab, golimumab or ustekinumab in inflammatory bowel diseases: characterization and implications in real-life clinical practice

Ylisaukko-oja

Puttonen

Jokelainen

et al. 2021

Scandinavian Journal of Gastroenterology

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Dose escalation is a common practice to optimize treatment with subcutaneously administered biologicals in Crohn's Disease (CD) and Ulcerative Colitis (UC). However, limited data is available on the extent of dose-escalation in real-life. Here, we analyzed treatment persistence, doseescalation, concomitant corticosteroid use, and costs of adalimumab, golimumab, and ustekinumab in inflammatory bowel diseases (IBD). Methods:This was a nationwide, retrospective, non-interventional registry study. All adult patients who were diagnosed with CD or UC and had purchased adalimumab, golimumab, or ustekinumab from Finnish pharmacies between 2008 and 2018 were included in the study and followed up for 24 months after treatment initiation. Results:A total of 2,884 patients were included in the analyses. For adalimumab, treatment persistence was higher for CD patients compared to UC patients both at months 12 (46.2% vs. 37.1%; p<0.0001) and 24 (26.1% vs. 19.7%; p<0.0001). For golimumab (UC), treatment persistence was 48.3% at month 12 and 28.1% at month 24. The 12-month treatment persistence rate for patients on ustekinumab (CD) was 47.1%. Cumulative doses exceeding the regular dosing according to the summary of product characteristics (SPC), was observed for adalimumab in CD during the first 6 months of treatment (62.9% of the treatment periods), golimumab in the later stages of the UC treatment (52-54% of treatment periods at months 7-24), and ustekinumab during the first 6 months (70.7%). Conclusions:Based on this study, dose-escalation of subcutaneously administered biologicals is a common clinical practice in IBD. This has implications for treatment costs, use of concomitant medications, and treatment outcomes.

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Rapidly achieving clinical remission in ulcerative colitis indicates better endoscopic and histological outcomes

Chen,

Tie,

Huang

et al. 2023

UEG Journal

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BackgroundClinical remission (CR) is the principal short‐term treatment target in patients with ulcerative colitis (UC). However, whether rapidly achieving CR indicates better outcomes remains unclear.ObjectivesWe aimed to explore the associations between the timing of CR and therapeutic outcomes in UC.MethodsThis study included UC patients from the UNIFI trial. Week‐2 CR and time to CR were the major variables of interest. Endoscopic remission (ER) at week 52 was the primary outcome. Multivariate logistic regression was performed to evaluate the association between variables and outcomes.ResultsWeek‐2 CR was associated with ER (aOR: 2.37 [95% CI: 1.28, 4.37], p = 0.006) and Histological remission (HR) (aOR: 2.87 [95% CI: 1.42, 5.72], p = 0.003) at week 52. Moreover, C‐reactive protein (CRP) remission could further stratify patients without CR and predict week‐52 outcomes. Patients with clinical activity + CRP remission (aOR: 0.49 [95% CI: 0.26, 0.93], p = 0.039) and clinical activity + CRP activity (aOR: 0.24 [95% CI: 0.11, 0.52], p < 0.001) had gradually decreased likelihood of achieving ER, when compared to those with CR. For time to CR, we found that the earlier to CR, the better endoscopic and histological outcomes patients would attain. Patients achieving CR at weeks 2, 4/8, 12/16 and >16 had gradually reduced proportions of ER (51.9% vs. 40.8% vs. 31.6% vs. 8.8%, p < 0.001) and HR (37.0% vs. 19.8% vs. 17.1% vs. 6.1%, p < 0.001) at week 52. Compared with week 2, achieving CR at weeks 4/8, 12/16 and >16 had 39%, 55% and 92% lower likelihoods of week‐52 ER, respectively.ConclusionsWeek‐2 CR indicates better outcomes in UC patients receiving ustekinumab. Moreover, achieving CR more rapidly is associated with higher probability of ER and HR.

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

Cited by 8 publications

References 41 publications

Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan

Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan

Dose–escalation of adalimumab, golimumab or ustekinumab in inflammatory bowel diseases: characterization and implications in real-life clinical practice

Rapidly achieving clinical remission in ulcerative colitis indicates better endoscopic and histological outcomes

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