Intestinal Research

Original Articles

Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in Japanese patients with Crohn’s disease: 3-year results from a real-world study: Tadakazu Hisamatsu, Yasuo Suzuki, Mariko Kobayashi, Takashi Hagiwara, Takeshi Kawaberi, Haruhiko Ogata, Toshiyuki Matsui, Mamoru Watanabe, Toshifumi Hibi; Intest Res 2021;19(4):408-418. Published online November 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00025

Background/Aims
Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings.
Methods
This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remission, mucosal healing, and Work Productivity and Activity Impairment (WPAI).
Results
The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malignancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained > 70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years > 2 to ≤ 3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n = 102) at baseline to 26.9 (n = 84) at 4 weeks.
Conclusions
Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting.

Citations

Citations to this article as recorded by

The position of anti-Tumor Necrosis Factor agents for the treatment of adult patients with Crohn’s disease
Stephen B. Hanauer, Byong Duk Ye, Raymond K. Cross, Silvio Danese, Geert D’Haens, Jinah Jung
Expert Review of Gastroenterology & Hepatology.2025;[Epub] CrossRef
Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
Naoto Saigusa, Takeshi Inaba
Nippon Daicho Komonbyo Gakkai Zasshi.2024; 77(2): 89. CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Clinical features of enteric and colo-duodenal fistula in patients with Crohn’s disease
Jun Su Lee, Sang-Bum Kang, Kwangbeom Park, Yong Sik Yoon, Chang Sik Yu, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Jong Lyul Lee, Sang Hyoung Park
Intestinal Research.2023; 21(3): 406. CrossRef
TNF-Alpha Inhibitors and Ustekinumab for the Treatment of Psoriasis: Therapeutic Utility in the Era of IL-17 and IL-23 Inhibitors
Julie J. Hong, Edward K. Hadeler, Megan L. Mosca, Nicholas D. Brownstone, Tina Bhutani, Wilson J. Liao
Journal of Psoriasis and Psoriatic Arthritis.2022; 7(2): 79. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Biological Therapies for the Management of Enteric Disease: Considerations for the Clinician
Adam Saleh, Usman Ansari, Shaadi Abughazaleh, Kerri Glassner, Bincy P Abraham
Biologics: Targets and Therapy.2022; Volume 16: 67. CrossRef
Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
Jung-Bin Park, Sang Hyoung Park
Intestinal Research.2022; 20(3): 279. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Adalimumab for induction of remission in patients with Crohn's disease: a systematic review and meta-analysis
Juntao Yin, Yang Li, Yangyang Chen, Chaoyang Wang, Xiaoyong Song
European Journal of Medical Research.2022;[Epub] CrossRef
Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

7,266 View
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17 Web of Science
14 Crossref

Inflammatory Bowel Diseases

Safety and effectiveness of adalimumab in the treatment of ulcerative colitis: results from a large-scale, prospective, multicenter, observational study: Haruhiko Ogata, Takashi Hagiwara, Takeshi Kawaberi, Mariko Kobayashi, Toshifumi Hibi; Intest Res 2021;19(4):419-429. Published online November 10, 2020; DOI: https://doi.org/10.5217/ir.2020.00033

Abstract PDF PubReader ePub

Background/Aims
Adalimumab has been shown to induce and maintain clinical remission in patients with moderate to severe ulcerative colitis (UC). However, no large-scale population-based studies have been performed in Japan. This study was conducted to evaluate the safety and effectiveness of adalimumab in clinical practice in Japanese patients with UC.
Methods
In this 52-week, prospective, multicenter, single-cohort, noninterventional, observational, postmarketing surveillance study, patients with moderate to severe UC received an initial subcutaneous injection of adalimumab 160 mg, followed by 80 mg at 2 weeks, and then 40 mg every other week. Safety assessments were the incidence of adverse drug reactions (ADRs) and serious ADRs. Effectiveness assessments were clinical remission, corticosteroid-free remission, mucosal healing, and change in C-reactive protein (CRP) levels from baseline.
Results
Of 1,593 registered patients, 1,523 (male, 57.6%; mean age, 41.8 years) and 1,241 patients were included in the safety and effectiveness populations, respectively. ADRs were reported in 18.1% and serious ADRs in 4.9% of patients. Clinical remission was achieved in 49.7% of patients at week 4, increasing to 74.4% at week 52. Corticosteroid-free remission rates increased over time, from 10.4% at week 4 to 53.1% at week 52. More than 60% of patients demonstrated mucosal healing at weeks 24 and 52. Mean CRP levels (mg/dL) decreased from 1.2 at baseline to 0.6 at week 4 and 0.3 at week 52.
Conclusions
This large real-world study confirmed the safety and effectiveness of adalimumab in patients with UC in Japan. No new safety concerns were identified.

Citations

Citations to this article as recorded by

Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. CrossRef
Real‐world experience of adalimumab therapy for patients with ulcerative colitis: A single tertiary medical center experience in Central Taiwan
Hsu‐Heng Yen, Yu‐Chun Hsu, Chu‐Hsuan Kuo, Tsui‐Chun Hsu, Yang‐Yuan Chen
Advances in Digestive Medicine.2023; 10(1): 28. CrossRef
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Safety of Adalimumab: An Analysis of the FDA Adverse Event Reporting System (FAERS) Database
Buthainah Ghanem
Jordan Journal of Pharmaceutical Sciences.2023; 16(3): 517. CrossRef
Infliximab versus Adalimumab: Can We Choose the Right One for the Right Patients with Ulcerative Colitis?
Sang Hyoung Park, Byong Duk Ye, Suk-Kyun Yang
Gut and Liver.2022; 16(1): 138. CrossRef
Adalimumab Efficacy for Management of Inflammatory Bowel Disease in Southwest Region of Iran
Pezhman Alavinejad, Sana Delavari, Abazar Parsi, Ali Akbar Shayesteh
Modern Care Journal.2022;[Epub] CrossRef
Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study
Seung Yong Shin, Soo Jung Park, Young Kim, Jong Pil Im, Hyo Jong Kim, Kang-Moon Lee, Ji Won Kim, Sung-Ae Jung, Jun Lee, Sang-Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young-Ho Ki
Intestinal Research.2022; 20(3): 350. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef
Do We Have an Opportunity to Avoid Opportunistic Infections in Asian Patients with Inflammatory Bowel Disease?
Suhyun Park, Sang Hyoung Park
Gut and Liver.2022; 16(5): 663. CrossRef
Latent and Active Tuberculosis Infection in Patients with Inflammatory Bowel Disease
Byung Chul Jin, Hee Jin Moon, Sang Wook Kim
The Korean Journal of Gastroenterology.2022; 80(2): 72. CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef
Circulating Profile of ECM-Related Proteins as Diagnostic Markers in Inflammatory Bowel Diseases
Katarzyna Komosinska-Vassev, Aleksandra Kałużna, Agnieszka Jura-Półtorak, Alicja Derkacz, Krystyna Olczyk
Journal of Clinical Medicine.2022; 11(19): 5618. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef

7,301 View
356 Download
13 Web of Science
14 Crossref

Inflammatory Bowel Diseases

Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behçet’s disease: results from a large real-world observational study: Yasuo Suzuki, Takashi Hagiwara, Mariko Kobayashi, Kazuo Morita, Tomoyo Shimamoto, Toshifumi Hibi; Intest Res 2021;19(3):301-312. Published online August 20, 2020; DOI: https://doi.org/10.5217/ir.2020.00013

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease.
Methods
This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels.
Results
Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P< 0.0001), patients taking concomitant oral corticosteroids (P< 0.0001), and those not self-administering adalimumab (P= 0.0257). At study end, global improvement rating was “effective” (n = 156, 40.7%) or “markedly effective” (n = 168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n = 324) to 0.58 at week 24 (n = 208) and 0.25 at week 156 (n = 37).
Conclusions
This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790)

Citations

Citations to this article as recorded by

Assessment of IL-6 Pathway Inhibition in Gastrointestinal Behçet’s Disease from Immunological and Clinical Perspectives
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Small bowel vasculitis? what a gastroenterologist should know - from diagnosis to management
João Carlos Gonçalves, Bruno Rosa, José Cotter
Current Opinion in Gastroenterology.2025; 41(3): 132. CrossRef
Optimal Treatment Approaches to Intestinal Behçet's Disease Complicated by Myelodysplastic Syndrome: The KASID and KSBD Multicenter Study
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European Journal of Gastroenterology & Hepatology.2024; 36(4): 445. CrossRef
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8,800 View
375 Download
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