Background: CT-P13 (RemsimaÃ?®, InflectraÃ?®) is a biosimilar of the infliximab reference product (RP; RemicadeÃ?®). The\naim of this study was to compare the 54-week efficacy, immunogenicity, safety, pharmacokinetics (PK) and\npharmacodynamics (PD) of CT-P13 and RP in patients with active rheumatoid arthritis (RA).\nMethods: In this multinational phase III double-blind study, patients with active RA and an inadequate response to\nmethotrexate (MTX) were randomized (1:1) to receive CT-P13 (3 mg/kg) or RP (3 mg/kg) at weeks 0, 2, 6 and then\nevery 8 weeks to week 54 in combination with MTX (12.5ââ?¬â??25 mg/week). Efficacy endpoints included American\nCollege of Rheumatology (ACR)20, ACR50 and ACR70 response rates, Disease Activity Score in 28 joints (DAS28),\nSimplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), European League Against Rheumatism\n(EULAR) response rates, patient-reported outcomes and joint damage progression. Immunogenicity, safety and PK/\nPD outcomes were also assessed.\nResults: Of 606 randomized patients, 455 (CT-P13 233, RP 222) were treated up to week 54. At week 54, ACR20\nresponse rate was highly similar between groups (CT-P13 74.7 %, RP 71.3 %). ACR50 and ACR70 response rates were\nalso comparable between groups (CT-P13 43.6 % and 21.3 %, respectively; RP 43.1 % and 19.9 %, respectively).\nDAS28, SDAI and CDAI decreased from baseline to week 54 to a similar extent with CT-P13 and RP. Radiographic\nprogression measured by Sharp scores as modified by van der Heijde was also comparable. With both treatments,\npatient assessments of pain, disease activity and physical ability, as well as mean scores on the Medical Outcomes\nStudy Short Form Health Survey (SF-36), improved markedly at week 14 and remained stable thereafter up to week\n54. The proportion of patients positive for antidrug antibodies at week 54 was similar between the two groups: 41.1\n% and 36.0 % with CT-P13 and RP, respectively. CT-P13 was well tolerated and had a similar safety profile to RP. PK/\nPD results were also comparable between CT-P13 and RP.\nConclusions: CT-P13 and RP were comparable in terms of efficacy (including radiographic progression),\nimmunogenicity and PK/PD up to week 54. The safety profile of CT-P13 was also similar to that of RP.\n(Continued on next page)
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