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CT-P13 in Rheumatoid Arthritis
The PLANETRA trial was a phase 3, randomized, double-blind, multicenter,
parallel- group study of CT-P13 in rheumatoid arthritis patients with active disease
despite treatment with ≥3 months of methotrexate dosed at 12.5–25 mg weekly
[ 4 ]. In the PLANETRA trial, eligible RA patients were randomized to receive
CT-P13 (n = 302) or Remicade® (n = 304) dosed at 3 mg/kg at weeks 0, 2, and 6
then every 8 weeks with the primary endpoints assessed at week 30 with continued
methotrexate administration. The primary aim of the PLANETRA trial was to
demonstrate therapeutic equivalence between the two treatment groups defined as
95% confidence intervals (CI) of treatment response within a margin of ±15% at
week 30. Week 30 response rates were similar for CT-P13 (60.9%)- and Remicade®
(58.6%)-treated patients with the 95% CI range of -6–10%, within the prespecified
equivalence margin. Adverse event profiles (CT-P13 60.1%, Remicade® 60.8%) at
week 30 and PK data profiles (AUC and Cmax values) measured after each infusion
were also equivalent between the two treatment groups [ 4 ]. At week 30, 25.8% of
CT-P13-treated patients and 25.4% of Remicade®-treated patients developed anti-
drug antibodies using ECL-based assays for ADA detection. Among patients con-
tinuing with the PLANETRA study to week 54, remission and response rates, PK
profiles, and adverse event rates were again comparable between the two treatment
groups. ADA positivity at week 54 was substantially higher than reported during
the PLANETAS trials for AS with 52.3% of CT-P13-treated and 49.5% of
Remicade®-treated patients having antibodies present by week 54 with lower resul-
tant response rates [ 16 ].
In the open-label extension study, beginning at week 54, PLANETRA study
patients treated with CT-P13 could continue with scheduled 3 mg/kg dosing every
8 weeks (n = 158), or Remicade®-treated patients could switch to CT-P13 at the
same dosing and interval for an additional 48 weeks (n = 144). Clinical efficacy and
adverse event rates were comparable between the continued versus switched groups,
with the proportions of CT-P13-treated patients with ADA also similar between the
patients who continued CT-P13 (49.1% at week 54, 46.4% at week 102) and the
patients who switched from Remicade® to CT-P13 (49.3% at week 54, 49.6% at
week 102) [ 17 ].
CT-P13 in Inflammatory Bowel Disease
There are limited published data commenting on the safety, efficacy, and bioequiv-
alence of CT-P13 for the inflammatory bowel diseases (IBD), Crohn’s disease
(CD), and ulcerative colitis (UC), consisting mostly of small retrospective studies
performed in Korea, Poland, or Hungary (Table 15.2) [ 18 ]. One of the larger, pro-
spective observational cohort studies using CT-P13 for IBD included 78 patients
(46 CD/32 UC with 28% CD and 16% UC patients having had prior biologic
C.Y. Ha and A. Kornbluth