Withdrawal of thiopurines in Crohn’s disease treated with scheduled adalimumab maintenance: a prospective randomised clinical trial (DIAMOND2)

Background The risk:benefit ratio of concomitant use of thiopurines with scheduled adalimumab (ADA) maintenance therapy for Crohn’s disease is controversial. The aim of this study is to identify the influence of withdrawal of thiopurines in patients in remission with combination therapy in an open-l...

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Published in:Journal of gastroenterology 2019-10, Vol.54 (10), p.860-870
Main Authors: Hisamatsu, Tadakazu, Kato, Shingo, Kunisaki, Reiko, Matsuura, Minoru, Nagahori, Masakazu, Motoya, Satoshi, Esaki, Motohiro, Fukata, Norimasa, Inoue, Satoko, Sugaya, Takeshi, Sakuraba, Hirotake, Hirai, Fumihito, Watanabe, Kenji, Kanai, Takanori, Naganuma, Makoto, Nakase, Hiroshi, Suzuki, Yasuo, Watanabe, Mamoru, Hibi, Toshifumi, Nojima, Masanori, Matsumoto, Takayuki
Format: Article
Language:English
Subjects:
Abdominal Surgery
Adalimumab
Adalimumab - adverse effects
Adalimumab - therapeutic use
Adolescent
Adult
Aged
Azathioprine - administration & dosage
Azathioprine - adverse effects
Azathioprine - therapeutic use
Biomarkers - blood
C-Reactive Protein - metabolism
Clinical trials
Colorectal Surgery
Corticosteroids
Crohn Disease - drug therapy
Drug Administration Schedule
Drug Therapy, Combination
Endoscopy, Gastrointestinal
Female
Gastroenterology
Gastrointestinal Agents - administration & dosage
Gastrointestinal Agents - adverse effects
Gastrointestinal Agents - therapeutic use
Hepatology
Humans
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - therapeutic use
Immunotherapy
Male
Medicine
Medicine & Public Health
Middle Aged
Monoclonal antibodies
Original Article—Alimentary Tract
Prospective Studies
Rankings
Remission
Remission Induction
Surgical Oncology
TNF inhibitors
Treatment Outcome
Tumor Necrosis Factor Inhibitors - adverse effects
Tumor Necrosis Factor Inhibitors - therapeutic use
Young Adult
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Summary:Background The risk:benefit ratio of concomitant use of thiopurines with scheduled adalimumab (ADA) maintenance therapy for Crohn’s disease is controversial. The aim of this study is to identify the influence of withdrawal of thiopurines in patients in remission with combination therapy in an open-label, randomised, controlled trial (DIAMOND2; UMIN000009596). Methods Patients in corticosteroid-free clinical remission (CFCR) for ≥ 6 months with ADA (40 mg, s.c., every other week) scheduled maintenance combined with thiopurines were randomised into two groups, “continue” (Con) or “discontinue” (Dis) group of thiopurines, whereas all other patients kept receiving scheduled ADA maintenance therapy for 52 weeks. The primary endpoint was the proportion of patients in CFCR at week 52. Secondary endpoints were endoscopic remission (ER), trough levels of ADA in serum, and safety. Results Fifty patients were randomised to Con or Dis groups. Characteristics of patients were not significantly different between the groups. CFCR and ER prevalence at week 52 were not significantly different between groups (log rank, P  = 0.704, P  = 1.000, respectively). Trough levels of ADA were not significantly different between groups ( P  = 0.515). The proportion of patients with AAA positivity at week 52 was not significantly different ( P  = 0.437). ER at week 0 was involved in ER and triple remission at week 52. No serious adverse effects were observed in either group. Conclusion Continuation of thiopurines > 6 months offers no clear benefit over scheduled ADA monotherapy. CFCR, ER, and ADA trough level at week 52 were not significantly different between groups. ER at week 0 may be involved in better long-term clinical outcomes.
ISSN:0944-1174
1435-5922
DOI:10.1007/s00535-019-01582-w