- The study results involves assessing of CT-P13 SC (90mg/120mg/180mg) vs CT-P13 IV (3mg/kg) in 50 patients in ratio (1:1:1:1) with RA, followed by a P-I/III study assessing CT-P13 SC (120mg, q2w) vs CT-P13 IV in 362 patients in ratio (1:1) with RA for 30wks.
- Collective results: @54wks. efficacy is comparable; DAS28 (CRP) and ACR20 are comparable in all cohorts; CT-P13 SC is non-inferior to CT-P13 IV, @22wks. similar ACR response, @6wk. SC 120mg safety is comparable to IV dose
- CT-P13 is a mAb, currently being evaluated in an additional 5yrs. study for RA and ankylosing spondylitis and has received approval in the US (marketed as Inflectra) in Apr’16, in Europe (marketed as Remsima) in Sept’13, additionally in other 89+ countries
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