Clinical–alimentary tractAdalimumab for Maintenance of Clinical Response and Remission in Patients With Crohn’s Disease: The CHARM Trial
Section snippets
Patients
CHARM included men and women 18–75 years of age with known CD of at least 4 months’ duration (radiologic/endoscopic confirmation required) that at the screening visits was moderately to severely active, as defined by a baseline Crohn’s Disease Activity Index (CDAI) score of 220–450 points. Concurrent therapies for CD, including stable dosages (for at least 4 weeks before screening) of azathioprine, 6-mercaptopurine, methotrexate, 5-aminosalicylates, sulfasalazine, oral mesalamine, and
Patient Disposition and Baseline Characteristics
A total of 854 patients enrolled in the trial and received induction therapy with 80 mg of adalimumab at week 0 and 40 mg of adalimumab at week 2 (Figure 1). Of these, 76 withdrew before randomization at week 4. The most common reasons for study discontinuation were adverse events and lack of efficacy. The remaining 778 patients were randomized at week 4 to receive placebo (n = 261), adalimumab 40 mg every other week (n = 260), or adalimumab 40 mg weekly (n = 257). A total of 505 enrolled
Discussion
Adalimumab, a fully human immunoglobulin G1 monoclonal antibody, is effective in inducing and maintaining long-term (56-week) clinical remission in patients with moderate to severe CD who have responded to induction therapy with adalimumab. Significant treatment differences between adalimumab and placebo groups in terms of remission and CDAI 100-point and 70-point responses were noted early (within 4 weeks after randomization) and were maintained throughout the double-blind phase. Consistent
References (36)
- et al.
Tumor necrosis factor: biology and therapeutic inhibitors
Gastroenterology
(2000) - et al.
Maintenance infliximab for Crohn’s disease: the ACCENT I randomised trial
Lancet
(2002) - et al.
Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn’s disease
Gastroenterology
(1999) - et al.
The incidence and management of infusion reactions to infliximab: a large center experience
Am J Gastroenterol
(2003) - et al.
Intravenous hydrocortisone premedication reduces antibodies to infliximab in Crohn’s disease: a randomized controlled trial
Gastroenterology
(2003) - et al.
Incidence and importance of antibody responses to infliximab after maintenance or episodic treatment in Crohn’s disease
Clin Gastroenterol Hepatol
(2004) - et al.
Anti-TNF-alpha therapy in ankylosis spondylitis
Cytokine
(2006) - et al.
Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC I trial
Gastroenterology
(2006) Tumour necrosis factor and Crohn’s disease
Gut
(1997)- et al.
Infliximab for the treatment of fistulas in patients with Crohn’s disease
N Engl J Med
(1999)
Infliximab maintenance therapy for fistulizing Crohn’s disease
N Engl J Med
A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn’s disease
N Engl J Med
Influence of immunogenicity on the long-term efficacy of infliximab in Crohn’s disease
N Engl J Med
Delayed hypersensitivity to infliximab (Remicade) re-infusion after a 2-4 year interval without treatment
Gastroenterology
A single dose, placebo controlled study of the fully human anti-tumor necrosis factor-alpha antibody adalimumab (D2E7) in patients with rheumatoid arthritis
J Rheumatol
Adalimumab, a fully human anti tumor necrosis factor-alpha monoclonal antibody, and concomitant standard antirheumatic therapy for the treatment of rheumatoid arthritis: results of STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis)
J Rheumatol
Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial
Arthritis Rheum
Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial
Arthritis Rheum
Cited by (0)
Supported by a research grant from Abbott Laboratories (Abbott Park, IL).
A list of the CHARM study investigators and sites appears in Appendix 1.
- 1
Jean-Frédéric Colombel, William Sandborn, Paul Rutgeerts, Robert Enns, Stephen Hanauer, Remo Panaccione, and Stefen Schreiber have served as consultants for Abbott Laboratories and have participated in continuing medical education events supported by unrestricted educational grants from Abbott Laboratories.
- 2
Dan Byczkowski, Ju Li, Jeffrey Kent, and Paul Pollack are employees of Abbott Laboratories.