Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis.

Abstract

BACKGROUND:

Adalimumab is a fully human, monoclonal antibody against tumor necrosis factor that is approved in Western countries for the treatment of moderately to severely active ulcerative colitis (UC).

METHODS:

This 52-week, phase 2/3, randomized, double-blind study evaluated adalimumab for induction and maintenance treatment in 273 anti-TNF-naive Japanese patients with UC who were refractory to corticosteroids, immunomodulators, or both. Patients received placebo, adalimumab 80/40 (80 mg at week 0, then 40 mg every other week), or adalimumab 160/80 (160/80 mg at weeks 0/2, then 40 mg every other week) in addition to background UC therapy.

RESULTS:

At week 8, remission rates were similar among treatment arms, but more patients treated with adalimumab 160/80 achieved response (placebo, 35 %; 80/40, 43 %; 160/80, 50 %; P = 0.044 for 160/80 vs placebo) and mucosal healing (placebo, 30 %; 80/40, 39 %; 160/80, 44 %; P = 0.045 for 160/80 vs placebo) compared with placebo. At week 52, more patients receiving adalimumab 40 mg every other week achieved response (18 vs 31 %; P = 0.021), remission (7 vs 23 %; P = 0.001), and mucosal healing (16 vs 29 %; P = 0.015) compared with placebo. Week 8 response to adalimumab was associated with greater rates of response (61 %), remission (46 %), and mucosal healing (57 %) at week 52 relative to the overall population. Rates of serious adverse events were similar between treatment arms.

CONCLUSIONS:

Induction with adalimumab 160/80 mg led to early response and mucosal healing. Maintenance adalimumab had greater rates of long-term response, remission, and mucosal healing compared with placebo. No new safety signals were identified.

• Authors: Yasuo Suzuki, Satoshi Motoya, Hiroyuki Hanai, Takayuki Matsumoto, Toshifumi Hibi, Anne M Robinson, Nael M Mostafa, Jingdong Chao, Vipin Arora, Anne Camez, Roopal B Thakkar, Mamoru Watanabe
• Journal: Journal of gastroenterology (J Gastroenterol) Vol. 49 Issue 2 Pg. 283-94 (Feb 2014) ISSN: 1435-5922 [Electronic] Japan
• PMID: 24363029 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenal Cortex Hormones
• Anti-Inflammatory Agents
• Antibodies, Monoclonal, Humanized
• Immunosuppressive Agents
• Adalimumab

Topics

• Adalimumab
• Adrenal Cortex Hormones
• Adult
• Anti-Inflammatory Agents (adverse effects, pharmacokinetics, therapeutic use)
• Antibodies, Monoclonal, Humanized (adverse effects, pharmacokinetics, therapeutic use)
• Colitis, Ulcerative (drug therapy)
• Double-Blind Method
• Drug Resistance
• Female
• Humans
• Immunosuppressive Agents
• Japan
• Maintenance Chemotherapy
• Male
• Middle Aged
• Remission Induction
• Severity of Illness Index
• Treatment Outcome