Short and long-term efficacy of adalimumab in ulcerative colitis: a real-life study

Angelison, Leif; Almér, Sven; Davíðsdóttir, Lóa; Hammarlund, Per; Lindgren, Stefan; Hindorf, Ulf; Marsal, Jan; Hertervig, Erik

doi:10.1080/00365521.2020.1713210

Cited by 6 publications

(8 citation statements)

References 31 publications

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“…Other studies have also certified that adalimumab can control most UC cases as soon as the 8th week of therapy and maintain this response up to the 52nd week (18,19). Angelison et al's study conducted on 118 UC patients with adalimumab for 3 months achieved clinical remission among 77% of participants, and the response rate of those with a history of treatment with infliximab was lower than naive patients (73% and 85%), which is in line with the results of the current study (20). Another study by Balint et al investigated adalimumab efficacy on 73 refractory UC cases (15).…”

Section: Discussionsupporting

confidence: 89%

“…Additionally, in Balint et al's study, 5.4% of moderate to severe UC cases required colectomy during the first (31). Based on different studies, the most common side effects related to IBD treatment with adalimumab include infections (11 -34%), malignancies (1.9%), and demyelinating disorders (0.7%) (17,20,24,31). The report of no side effects in the current study proved that there is no new concern about the adalimumab safety profile.…”

Section: Discussionmentioning

confidence: 99%

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Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran

et al. 2022

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Background: In recent years, biological drugs, including antitumor necrosis factors, have revolutionized the treatment of inflammatory bowel disease (IBD); however, there is no consensus about the superiority of adalimumab over infliximab. Objectives: This study was designed to evaluate the efficacy of adalimumab for the management of IBD in the southwest region of Iran. Methods: During this prospective observational study, the patients with active IBD and a history of no response to previous treatments that referred to an IBD clinic were included. Moreover, this study evaluated and compared the effectiveness of treatment, including clinical remission rate, disease activity index (the Mayo score in ulcerative colitis (UC) patients and the Crohn’s Disease Activity Index (CDAI) in Crohn’s disease (CD) patients), clinical response, and side effects related to adalimumab injection in 0, 12th, 24th, and 52nd weeks after treatment. Results: A total of 71 patients, including 42 male and 29 female, with a mean age of 29 years, were included. In this study, 37 and 34 patients were diagnosed with UC (52.1%, 20 male and 17 female) and CD (47.8%, 22 male and 12 female), respectively. The time to remission in the UC group was significantly longer than in the CD group (10.05 and 1.71 months; P < 0.0001). Clinical remission rate (≥ 2 points reduction in the Mayo score) in the 12th week among UC patients after treatment with adalimumab was 67.5% and raised to 100% (all the UC patients) in the 24th and 52nd weeks after treatment. None of the UC patients experienced disease recurrence. In CD patients, the CDAI significantly decreased during the treatment time (P < 0.0001); however, all CD patients (100%) experienced disease recurrence after a mean time of 2.59 ± 0.55 months (within 2 - 4 months) (P < 0.0001). Failure of treatment was observed in 94.1% of CD patients (n = 32); nevertheless, none of the UC patients had treatment failure (P < 0.0001). There were no complications related to adalimumab, and no patients needed colectomy during the study period. Conclusions: Adalimumab has a positive effect on the improvement of clinical symptoms, reduction of disease activity, prevention of disease recurrence, and need for colectomy in moderate to severe UC patients. However, adalimumab has no efficacy in the improvement of CD patients, and failure of treatment was observed in most of these patients. Adalimumab could be a therapeutic option for the management of UC with prior failure of treatment.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran

et al. 2022

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“…Real-world data supported the efficacy of adalimumab often showing improved performance [ 22 - 23 ]. This could be explained by varying reported outcomes and patients requiring dose-escalation being classed as treatment responders.…”

Section: Reviewmentioning

confidence: 99%

The Efficacy of Currently Licensed Biologics for Treatment of Ulcerative Colitis: A Literature Review

Awan¹,

Fatima²,

Eaw³

et al. 2023

Cureus

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Biologics have been emerging as promising therapies in ulcerative colitis (UC) patients who are refractory to conventional medical treatment. This literature review aims to appraise the existing evidence on the efficacy and safety of NICE approved biological therapies, of which there are currently five licensed drugs, available for the treatment of UC in adults. An initial search was performed using National Institute of Clinical Excellence (NICE) guidelines. A further literature search of EMBASE, MEDLINE, Science Direct and Cochrane Library databases was done, resulting in a total of 62 studies being included in this review. Recent and seminal papers were included. Inclusion criteria for this review were adult participants and English papers only. In most studies, anti-tumour necrosis factor ɑ (TNFɑ) naïve patients were found to have improved clinical outcomes. Infliximab was found to be highly effective in inducing short-term clinical response, clinical remission as well as mucosal healing. However, loss of response was common and dose escalation was often required for achievement of long-term efficacy. Adalimumab was found to have both short-term and long-term efficacy which was also supported by real-world data. Golimumab was shown to have comparable efficacy and safety profiles to other biologics, although lack of therapeutic dose monitoring and loss of response is a barrier to optimising golimumab treatment efficacy. Vedolizumab was shown to have higher clinical remission rates when compared to adalimumab in a head-to-head trial, and the most cost-effective biologic when calculating quality-adjusted life years. Ustekinumab was found to significantly improve clinical remission rates in UC patients who were previously unresponsive to other biological treatments. However, as this is a newly licensed drug, there is limited literature currently available. Further, head-to-head studies are required to help determine the optimal treatment for patients with UC. With patents expiring, the development of biosimilars will help to reduce costs and increase the availability of these drugs to patients.

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“…A retrospective cohort study based on data from the ENEIDA registry reported that failure to achieve response at 12 weeks was a clinical predictor of colectomy [ 8 ]. A randomized controlled trial reported that high C-reactive protein (CRP) levels, primary sclerosing cholangitis comorbidity, and female sex were predictors of failure [ 9 ]. Previous biologic exposure and disease activity at eight weeks after induction were also reported to be predictors of ADA [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

“…Predictive factors for primary and secondary failure have been reported [8][9][10][11]. A retrospective cohort study based on data from the ENEIDA registry reported that failure to achieve response at 12 weeks was a clinical predictor of colectomy [8].…”

Section: Introductionmentioning

confidence: 99%

Albumin change predicts failure in ulcerative colitis treated with adalimumab

Ishida,

Takahashi,

Asai

et al. 2024

PLoS ONE

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Anti-tumor necrosis factor (TNF) -α antibodies, including infliximab (IFX), adalimumab (ADA), and golimumab, which were the first biologic therapeutic agents, have a crucial position in advanced therapy for ulcerative colitis (UC). We aimed to investigate serum albumin (Alb) change as a prognostic factor for the therapeutic effect of ADA in UC. Thirty-four patients with UC treated with ADA were enrolled in this study and were divided into failure and non-failure groups. Biological data, such as Alb were compared between the two groups. Thirteen patients showed failure within six months. Examination of the biological data showed a significant difference between the two groups only in the week 2/week 0 Alb ratio. In receiver-operating characteristic (ROC) curve analysis to predict failure, the cut-off value of week 2/week 0 Alb ratio was 1.00, and the area under the curve was 0.868 (95% confidence interval: 0.738–0.999). In addition, in the sub-group analysis of only clinically active patients, the week 2/week 0 Alb ratio of the non-failure group was significantly higher than that of the failure group, and the cut-off-value in ROC analysis was 1.00. Week 2/week 0 Alb ratio ≤ 1 predicts failure within six months of ADA for UC.

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Short and long-term efficacy of adalimumab in ulcerative colitis: a real-life study

Cited by 6 publications

References 31 publications

Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran

Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran

The Efficacy of Currently Licensed Biologics for Treatment of Ulcerative Colitis: A Literature Review

Albumin change predicts failure in ulcerative colitis treated with adalimumab

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