Primary endpoint was clinical response at wk6 in patients enrolled after dose selection. Secondary endpoints at wk6 were clinical remission, mucosal healing, and change from baseline in IBDQ. Primary analysis population for efficacy consisted of patients randomized after dose selection (n = 774); for safety, all treated patients in Ph2 and 3 were combined (n = 1065). Results: 774 patients were randomized in the primary analysis population; 759 patients (98%) completed through wk6. Significantly higher proportions of patients find more who received GLM were in clinical response, clinical remission, mucosal healing and showed improvement in the IBDQ at wk6 vs PBO

(Table). Through wk6, proportions of patients with AEs LEE011 were similar for the combined GLM and PBO grps (39.1% and 38.2%, resp); 3.0% and 6.1% of patients, resp, had SAEs. There was a death in the GLM 400 mg/200 mg grp; a single case of demyelination was reported in this grp. Injection site reactions were uncommon and comparable across GLM grps. Malignancy rates were 0.3%. 0.0%, and 0.3% in the PBO, GLM 200 mg/100 mg, and GLM 400/200 mg grps, resp. Conclusion: Induction regimens

of SC GLM induced clinical response, clinical remission, mucosal healing and improved quality of life in anti-TNF naïve UC patients. Safety of GLM induction was consistent with the safety profile of GLM in labeled rheumatologic indications and other anti-TNFs. Key Word(s): 1. golimumab; 2. ulcerative colitis; 3. induction; 4. anti-TNF; Table: Primary and major secondary endpoints at wk6 among randomized patients after dose selection     GLN   PBO 200 mg/100 mg 400 mg/200 mg 3 patients prospectively excluded

from efficacy analyses due to misconduct; their safety data is included 133 (51.8%) p < 0.0001* 142(55.0%) p < 0.0001* 48(18.7%) p < 0.0001 46(17.8%) p < 0.0001 111(43.2%) p = 0.0005 117(45.3%) p < 0.0001 27.4 p < 0.0001 27.0 p < 0.0001 Presenting Author: XIAOCANG CAO Additional Authors: ZHIBO HAN Corresponding Author: XIAOCANG CAO Affiliations: tianjin medicl university general hospital; Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Peking Union of Medical Amino acid College Objective: MSCs have been found to have significant immunosuppressive capacities which make it as a potential treatment for various immune disorders including IBD. Many studies are being performed to further elucidate the mechanism of immune modulation by MSCs, while the effect molecule seems different between the cell of human and mice. Furthermore, MSCs pretreated by proinflammatory cytokines such as INFr and TNFa obtain intensive immunoregulatory effect, thus far the qualification of activated MSCs is still unclear, especially for human cell, which limits farther exploration. Here, we just defined hMSChireg, a subpopulation of human mesenchymal stem cells with character of CD106+, which exhibits unique immune regulatory property.