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P396 Adalimumab induction therapy achieves clinical remission and response in chinese patients with Crohn's Disease

K.-C. Wu*1, Z.H. Ran2, X. Gao3, M. Chen4, J. Zhong5, J.-Q. Sheng6, M.A. Kamm7, 8, S. Travis9, A.M. Robinson10, K. Wallace10, M. Shapiro10, Y. Li10, R.B. Thakkar10

1Xijing Hospital of the Fourth Military Medical University, Gastroenterology, Xi’an, China, 2Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, 3The Sixth Affiliated Hospital of Sun Yat-sen University, Gastroenterology, Guangzhou, China, 4The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, 5Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China, 6The Military General Hospital of Beijing, PLA, Gastroenterology, Beijing, China, 7St. Vincent’s Hospital, Gastroenterology, Melbourne, Australia, 8The University of Melbourne, Gastroenterology, Parkville, Australia, 9Translational Gastroenterology Unit, Gastroenterology, Oxford, United Kingdom, 10AbbVie Inc., Global Pharmaceutical Research & Development, North Chicago, United States

Background

Adalimumab (ADA) has demonstrated efficacy for induction and maintenance of remission in patients (pts) with Crohn's disease (CD) in Western and Japanese studies. The 8 week (wk) efficacy and safety of ADA is reported in Chinese pts with moderately to severely active CD and elevated high-sensitivity (hs)-CRP in ongoing Study M14-232 (NCT02015793).

Methods

In this Phase 2 study, adult Chinese pts with CD [CD Activity Index (CDAI), 220-450; hs-CRP, ≥3 mg/L] were enrolled. Pts (N=30 total), were randomized 1:1 and stratified by CD severity (CDAI ≤300 or >300) to receive 1 of 2 ADA induction dosing regimens for the 8 wk double-blind (DB) period: 160/80 mg at wks 0/2, 40 mg at wks 4 and 6 OR 80 mg at wk 0, 40 mg at wks 2, 4, and 6. At wk 8, all patients were able to enroll in an 18 wk open-label (OL) phase to receive 40 mg ADA every other wk. Efficacy outcomes assessed included: remission (CDAI <150), response [decrease in CDAI ≥70 points from baseline (BL)], and reductions from BL in hs-CRP and fecal calprotectin (FC) levels over time. Nonresponder imputation (NRI) was used for missing categorical data and last observation carried forward (LOCF) was used for missing hs-CRP and FC. No formal hypothesis testing was performed.

Efficacy outcomes in ADA-treated patients

Week 2Week 2Week 4Week 4Week 6Week 6Week 8Week 8
80/40 (N=15)160/80 (N=15)80/40 (N=15)160/80 (N=15)80/40 (N=15)160/80 (N=15)80/40 (N=15)160/80 (N=15)
Response66.780.093.393.393.386.793.386.7
Remission26.746.740.066.760.073.360.066.7
Median reduction from BL in hs-CRP, mg/L-14.1-25.4-12.1-21.1-12.7-21.6-11.9-21.6
Median reduction from BL in FC, mcg/gNDND-135-207NDND93-274

Results

Enrolled pts had mean age 34.5 years (yrs), mean CD duration 2.6 yrs, 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; corresponding values for FC were 802 and 945 mcg/g. BL use of immunomodulators and corticosteroids was similar between groups (overall 70% and 27% of patients, respectively). Clinical and biological response was observed at wk 2 in most pts in both groups (Table), and was maintained from wks 4 to 8. Remission rates increased over time and were numerically greater in the 160/80 group at each visit v. the 80/40 group. Greater median reductions from BL in hs-CRP levels at each visit and greater median reductions in FC at wks 4 and 8 were observed at each visit in the 160/80 group v. the 80/40 group. Adverse event rates were similar in the 80/40 (40%) and 160/80 (46.7%) groups.

Conclusion

Treatment of Chinese pts with moderately to severely active CD with 160/80 ADA induction resulted in achievement of remission in 2/3 of pts at wk 4. The safety profile of ADA was consistent with previous trials. High response and remission rates may reflect a short duration of disease.