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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
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Abstract
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ePub - 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
- 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
- Effect of Perianal Fistula on the Quality of Life and Work Productivity of Patients with Crohn's Disease: Report of a Questionnaire Survey
- 7,073 View
- 336 Download
- 17 Web of Science
- 13 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
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Abstract
PDFPubReaderePub
- 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
- Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
- 7,156 View
- 351 Download
- 13 Web of Science
- 14 Crossref
- Inflammatory bowel diseases
- Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn’s disease in Japanese and Korean patients: the OPERA study
- Masayuki Saruta, Dong Il Park, Young-Ho Kim, Suk-Kyun Yang, Byung-Ik Jang, Jae Hee Cheon, Jong Pil Im, Takanori Kanai, Tatsuro Katsuno, Yoh Ishiguro, Makoto Nagaoka, Naoki Isogawa, Yinhua Li, Anindita Banerjee, Alaa Ahmad, Mina Hassan-Zahraee, Robert Clare, Kenneth J. Gorelick, Fabio Cataldi, Mamoru Watanabe, Toshifumi Hibi
- Intest Res 2020;18(1):45-55. Published online January 30, 2020
- DOI: https://doi.org/10.5217/ir.2019.00039
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Abstract
PDFPubReaderePub
- Background/Aims
PF-00547659 is a monoclonal antibody against human mucosal addressin cell adhesion molecule-1 (MAdCAM-1) that prevents the binding of α4β7+ lymphocytes to MAdCAM-expressing sites in the gastrointestinal tract with high affinity and selectivity, and is being developed for the treatment of Crohn’s disease (CD).
Methods
OPERA is a randomized, multicenter, double-blind, placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics of PF-00547659 following subcutaneous administration in subjects with active CD, a history of failure or intolerance to anti-tumor necrosis factor and/or immunosuppressants, high-sensitivity C-reactive protein > 3.0 mg/L, and ulcers on colonoscopy. The primary endpoint was Crohn’s Disease Activity Index-70 response at week 8 or 12. Subpopulation analyses for Asian subjects were performed as some differences are observed in genetics and clinical phenotypes in Asian CD patients compared with Western patients.
Results
In this study, 265 CD subjects were randomized, with a subpopulation of 21 subjects (8 Japanese and 13 Korean) defined as the Asian population. In the overall and Asian populations; PF-00547659 was pharmacologically active as evidenced by soluble MAdCAM and circulating β7+ central memory CD4+ T-lymphocytes, although no clear evidence of efficacy was observed in any clinical endpoints; pharmacokinetics of PF-00547659 in the Asian subpopulation was generally comparable to the overall population; and the safety profile of PF-00547659 appeared acceptable up to 12 weeks of treatment.
Conclusions
In the overall and Asian populations, efficacy of PF-00547659 could not be demonstrated using any clinical endpoints compared with placebo. Pharmacokinetics and safety of PF-00547659 were generally comparable. Further studies with larger numbers of patients are required to confirm our results. (Trial Registration Number: NCT01276509) -
Citations
Citations to this article as recorded by- Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease
Hiroshi Nakase
Internal Medicine.2025;[Epub] CrossRef - Novel Histone Deacetylase 6 Inhibitor Confers Anti-inflammatory Effects and Enhances Gut Barrier Function
Jae-Young Lee, Hyun Woo Ma, Ji Hyung Kim, I Seul Park, Mijeong Son, Keun Ho Ryu, Jieun Shin, Seung Won Kim, Jae Hee Cheon
Gut and Liver.2023; 17(5): 766. CrossRef - Downregulation of Heat Shock Protein 72 Contributes to Fibrostenosis in Crohn’s Disease
Seung Won Kim, Jae-Young Lee, Han Cheol Lee, Jae Bum Ahn, Ji Hyung Kim, I Seul Park, Jae Hee Cheon, Duk Hwan Kim
Gut and Liver.2023; 17(6): 905. CrossRef - Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef - Renin–angiotensin system in intestinal inflammation—Angiotensin inhibitors to treat inflammatory bowel diseases?
Hanne Salmenkari, Riitta Korpela, Heikki Vapaatalo
Basic & Clinical Pharmacology & Toxicology.2021; 129(3): 161. CrossRef - Anti-integrin drugs in clinical trials for inflammatory bowel disease (IBD): insights into promising agents
Virginia Solitano, Tommaso Lorenzo Parigi, Elisa Ragaini, Silvio Danese
Expert Opinion on Investigational Drugs.2021; 30(10): 1037. CrossRef - Emerging therapeutic options in inflammatory bowel disease
Jesus K Yamamoto-Furusho, Norma N Parra-Holguín
World Journal of Gastroenterology.2021; 27(48): 8242. CrossRef
- Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease
- 16,508 View
- 194 Download
- 7 Web of Science
- 7 Crossref
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