DOP061 Phase III randomised, double-blind, controlled trial to compare biosimilar infliximab (CT-P13) with innovator infliximab in patients with active Crohn's disease: early efficacy and safety results
Kim Y.H.*1, Ye B.D.2, Pesegova M.3, Alexeeva O.4, Osipenko M.5, Lahat A.6, Dorofeyev A.7, Salamon A.8, Fishman S.9, Levchenko O.10, Cheon J.H.11, Scribano M.L.12, Mateescu R.-B.13, Lee K.M.14, Eun C.S.15, Lee S.J.16, Lee S.Y.16
1Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea 2University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea 3Krasnoyarsk Regional clinical hospital, Krasnoyarsk, Russian Federation 4Nizhny Novgorod Regional Clinical Hospital n.a. N.A.Semashko, Nizhny Novgorod, Russian Federation 5Novosibirsk State Medical University, Novosibirsk, Russian Federation 6Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel and Sackler Faculty of Medicine, Tel Aviv University, Ramat-Gan, Israel 7Medical Center LLC Ukrainian German Antiulcer Gastroenterology Center BIK Kyiv, Kyiv, Ukraine 8Tolna Megyei Balassa János Kόrház, Szekszárd, Hungary 9Tel Aviv Sourasky Medical Center, Tel Aviv, Israel 10Municipal Institution Odesa Regional Clinical Hospital, Odesa, Ukraine 11Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea 12Azienda Ospedaliera San Camillo Forlanini, Roma, Italy 13Gastroenterology Dept. at Colentina Clinical Hospital AND “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania 14St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, South Korea 15Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, South Korea 16CELLTRION, Inc., Incheon, South Korea
CT-P13 is a biosimilar of innovator infliximab (INX) and has been approved for all indications by the European Medicines Agency in 2013 and Food and Drug Administration in 2016.
This study was a randomised, double-blind, parallel-group, phase III study conducted in patients with moderate to severe CD. The primary objective of the study was to compare efficacy between CT-P13 and INX in terms of Crohn's Disease Activity Index (CDAI)-70 response rates at Week 6. CDAI-70 response and CDAI-100 response were defined as reductions from baseline in the CDAI score of at least 70 and 100 points, respectively. Clinical remission was defined as an absolute CDAI score of less than 150 points . Comparisons between the 2 treatment groups up to Week 6 were evaluated.
Of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed study up to Week 6. At Week 6, CDAI-70 response rate of CT-P13 was quite similar to that of INX (CT-P13, 71.4%; INX, 75.2%; p-value = 0.5613). Similar and consistent trends were observed in proportion of patients achieving CDAI-100 response (CT-P13, 61.9%; INX, 64.4%; p-value=0.7744) and clinical remission rate of 42.9% and 44.6% (p-value = 0.8329) in CT-P13 and INX treatment group, respectively (Table 1). The number of patients with at least one treatment-emergent adverse event (TEAE) showed a similar proportion in the 2 treatment groups (CT-P13, 30.6% [34/111]; INX, 35.8% [39/109]). The proportion of number of patients with at least one treatment-emergent serious adverse event (TESAE) was also comparable between treatment groups (CT-P13, 1.8% [2/111]; INX, 1.8% [2/109]). TEAEs of special interest including infusion-related reactions and infections related to study drug were reported in similar between the 2 treatment groups (CT-P13, 5.4% [6/111]; INX, 5.5% [6/109] as infusion-related reactions, CT-P13, 2.7% [3/111]; INX, 1.8% [2/109] as infections).
The efficacy of CT-P13 was similar to INX in terms of CDAI-70, CDAI-100 and clinical remission up to Week 6 in patients with CD. In addition, CT-P13 was well tolerated with a similar safety profile to that of INX up to Week 6. These results are consistent with randomised controlled studies of INX and other published studies and further reinforced now within the randomised controlled settings [1–3].
 Colombel JF, Sandborn WJ, Reinisch W, et al, (2010), Infliximab, azathioprine, or combination therapy for Crohn's disease, N Engl J Med, 362(15):1383–95
 Gecse KB, Vegh Z, Kurti Z, et al, (2016), Efficacy and safety of biosimilar infliximab after one-year: results from a prospective nationwide cohort, United European Gastroenterol J, 4(5S):A59–60
 Jørgensen KK, Olsen IC, Goll GL, et al, (2016), Biosimilar infliximab (CT-P13) is not inferior to originator infliximab: results from the 52-week randomized nor-switch trial, United European Gastroenterol J, 2(Supplement 1)