Adalimumab (Humira)
This drug is a recombinant human immunoglobulin (Ig) G1 monoclonal antibody that binds with high affinity and specificity to human soluble TNF-alpha but not to lymphotoxin (TNF-beta). Results have shown that the immunogenicity of adalimumab is low compared with the infliximab (Peyrin-Biroulet L et al, 2007)Peyrin-Biroulet L, Laclotte C, Bigard MA. Adalimumab maintenance therapy for Crohn's disease with intolerance or lost response to infliximab: an open-label study. Aliment Pharmacol Ther. 2007;25(6):675-80.
Adalimumab was approved in 2007 for inducing and maintaining clinical remission in adult patients with moderate-to-severe Crohn's disease who have had an inadequate response to conventional therapy, or have lost response to or are intolerant to infliximab.
Adalimumab is given as subcutaneous injections, with maintenance treatment being administered as one injection every other week. The patient can self administer the injections.
Two placebo-controlled trials, CLASSIC I and CLASSIC II, showed that adalimumab was effective for both induction and maintenance of remission in patients who were previously naive to anti-TNF therapy. Adalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial. The rates of remission at week 4 in the adalimumab 40 mg/20 mg, 80 mg/40 mg, and 160 mg/80 mg groups were 18% (P = 0.36), 24% (P = 0.06), and 36% (P = 0.001), respectively, and 12% in the placebo group. The optimal induction dosing regimen for adalimumab in this study was 160 mg at week 0 followed by 80 mg at week 2 (Hanauer SB et al, 2006)Hanauer SB, Sandborn WJ, et al. Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial. Gastroenterology. 2006 Feb;130(2):323-33 . Adalimumab was able to induce and maintain clinical remission for up to 56 weeks in patients with moderate to severe Crohn's disease naive to anti-TNF treatment (Sandborn WJ et al, 2007)Sandborn W et al. Certolizumab pegol (CIMZIATM), a humanized anti-TNF PEGylated Fab' fragment, is safe and effective in the maintenance of response and remission following induction in active Crohn's disease: a Phase III study (PRECiSE) .
The CHARM trial (Colombel JF et al, 2007)Colombel JF, Sandborn WJ, et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology. 2007 Jan;132(1):52-65 confirmed the same effects in patients who were either were naive to infliximab therapy or who had previously been on infliximab therapy. In patients who had lost response or become intolerant of infliximab, the GAIN trial results (Mannon P et al, 2007)Mannon PJ, Fuss IJ et al. Anti-IL-12 Crohn's Disease Study Group. Anti-interleukin-12 antibody for active Crohn's disease. N Engl J Med. 2004;351(20):2069-79 showed a benefit from adalimumab therapy induction with remission at 4 weeks.
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