Maintenance of Remission over 1 Year in Patients with Active Crohnʼs Disease Treated with Adalimumab

Medical Management of Crohn's Disease

“…Adalimumab at a dosage of 40-mg subcutaneously administered every other week was as efficacious as weekly dosing. 98,99 In these trials, adalimumab was generally well tolerated.…”

“…Newer biologic agents such as adalimumab, certolizumab, and natalizumab have demonstrated excellent efficacy and safety in early trials. [98][99][100][101][102][103][104][105][106] Adalimumab has been shown in two randomized placebo controlled trials (CLASSIC 1, CLASSIC 2) to be effective for induction and maintenance of clinical remission in patients with moderate to severely active CD. 98,99 Induction of remission was achieved after 4 weeks of adalimumab therapy and clinical remission was maintained for up to 56 weeks in patients with moderate to severely active CD naive to other anti-TNF therapy.…”

Current and future anti-TNF therapy for inflammatory bowel disease

“…The rate of clinical response (defined as decrease in CDAI of 70 points from baseline) at week 4 was also significantly higher in the adalimumab group (52% vs 34%, P < 0.001). • Clinical trials of adalimumab in Crohn's disease and rheumatoid arthritis have shown no differences between adalimumab and placebo groups with respect to the incidence of adverse events, serious adverse events, infections, and serious infections [19][20][21][22][23][24][25][26]. Adverse events included injection-site reactions, development of autoantibodies (antinuclear and anti-dsDNA), and infection (including tuberculosis).…”

“…Clinical response (defined as decrease in CDAI of 100 points from baseline) at week 4 was seen in 50% and 40% of patients treated with adalimumab at 160/80 and 80/40 mg, respectively, compared with 25% of patients in the placebo group (P < 0.05 for the adalimumab 160/80 group). • A total of 275 of the patients who completed CLASSIC I entered CLAS-SIC II, a long-term study of adalimumab for maintenance of remission published only in abstract form by Sandborn et al[19,20].…”

“Mind the Gap”

“…At 1 year, maintenance of remission in 55 initial remission patients was seen in 74% (13/19) of patients given 40 mg every other week, 83% (15/18) of patients given 40 mg every week, and 44% (7/18) of patients given placebo. 63 Colombel and colleagues recently reported results of the double-blind placebo-controlled 56-week CHARM trial, which evaluated ADA for maintenance of clinical remission (CDAI <150) in patients who had responded (CDAI decrease Z70 points) to 4 weeks of open-label ADA induction therapy. 64 Four hundred ninety-nine patients who responded were randomized to placebo, ADA 40 mg every week, or ADA 40 mg weekly through week 56.…”