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Background

Adalimumab (ADA) is approved for treatment of moderate to severe Crohn's disease (CD) in Western and Japanese countries; however, ADA has not been tested in Chinese patients (pts) with CD. This study evaluated the efficacy and safety of ADA treatment from weeks (wks) 8 to 26 in Chinese pts with moderate to severe CD and elevated high-sensitivity (hs)-CRP.

Methods

Adult Chinese pts (N = 30) with CD [CD Activity Index (CDAI), 220 to 450; hs-CRP, ≥3 mg/L] were randomized 1:1 and stratified by CD severity (CDAI ≤300 or >300) to receive double-blind (DB) ADA-160/80 mg or -80/40 mg at wks 0/2, followed by ADA 40 mg at wks 4 and 6. At wk 8, all pts received open-label (OL) ADA 40 mg every other week (eow) to wk 26. Pts with flares/nonresponse at or after wk 12 could receive OL ADA 80 mg eow. Efficacy outcomes assessed at wks 8, 12, 16, 20 and 26 were: remission (CDAI <150), response (decrease in CDAI ≥70 points from baseline [BL]), and reduction from BL in hs-CRP. Nonresponder imputation was used for missing CDAI data and for pts who dose-escalated. Last observation carried forward was used for missing hs-CRP data; no formal hypothesis testing was performed.

Results

Mean age was 34.5 years, 20% were female, mean CD duration 2.6 years, median weight 49.3 kg, and mean CDAI 315 at BL. Median BL hs-CRP levels in the 80/40 and the 160/80 groups were 30.6 and 31.9 mg/L, respectively. BL use of immunomodulators and corticosteroids was similar between groups (overall 70% and 27% of pts, respectively). 8 pts discontinued prior to week 26 (N = 4 per group). At week 8 of the DB period, response (87%–93%) or remission (60%–67%) was observed in most pts in the 80/40 and 160/80 groups; these rates were sustained during the OLE phase to wk 26 (Table). 3 pts dose escalated (n = 1, ADA 80/40; n = 2, ADA 160/80), and 1 of the dose escalators (ADA 160/80) achieved remission at wk 26. Median change from BL in hs-CRP was greater with ADA 160/80 versus ADA 80/40 at most observation points from weeks 8 to 26. Adverse event rates from weeks 0 to 26 were similar in the 80/40 (73%) and 160/80 (67%) groups.

Conclusions

ADA 160/80 induction therapy was associated with a shorter time to achievement of remission and ongoing therapy with ADA 40 mg eow resulted in sustained efficacy in 2/3 of Chinese pts with moderately to severely active CD to week 26. Inflammation as measured by hs-CRP decreased over time with both ADA doses. The safety profile of ADA was consistent with previous trials.

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Copyright © 2016 Crohn's & Colitis Foundation of America, Inc.
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