Session Information
Session Type: Late-Breaking Abstracts
Background/Purpose: CT-P13 is a biosimilar of infliximab (INX), approved by the European Medicines Agency. The objective of this open-label Phase 3 extension study was to confirm long-term efficacy and safety of CT-P13 and to investigate switching from INX to CT-P13, in patients (pts) with rheumatoid arthritis (RA).
Methods: The PLANETRA Study was a 54-week (wk), randomized, double-blind, parallel-group study demonstrating efficacy and safety equivalence of CT-P13 (3 mg/kg) compared with INX when co-administered with methotrexate (12.5-25 mg/wk) and folic acid (≥5 mg/wk, oral dose) every 8 wks in pts with RA (Yoo DH ARD2013;72(S3):73). In total, 302/455 pts who completed the scheduled visits were entered into the open-label extension phase for an additional 48 wks: 158 pts were maintained with CT-P13 (maintenance group) and 144 pts switched from INX to CT-P13 (switch group). Efficacy (including ACR20/50/70) and safety assessments including immunogenicity were monitored throughout the study.
Results: At wk 54, ACR20/50/70 response rate were similar between groups (CT-P13: 76.8%/45.7%/21.9%; INX 77.5%/50.0%/23.9%, respectively). At wk 78, ACR20/50/70 response rate was comparable for the maintenance group (71.5%/48.3%/24.5%) and switch group (78.2%/47.9%/29.6%). Through wk 102, ACR20/50/70 response rates were maintained and were similar in each group; 72.2%/48.3%/24.5% and 71.8%/51.4%/26.1%, respectively. Good and moderate EULAR-CRP responses at wks 54, 78 and 102 were observed in 89.4%/79.5%/81.5% of pts in the maintenance group and 87.3%/85.9%/76.8% of pts in the switch group, respectively. Changes in DAS28-CRP from baseline were comparable between the two groups: −2.4/−2.4/−2.4 in the maintenance group; −2.4/−2.6/−2.5 in the switch group, at wks 54, 78 and 102 respectively). EULAR-ESR response rates and DAS28-ESR results were also comparable between groups (Table). The proportion of pts positive for anti-drug antibody (ADA) was comparable between the two groups throughout the study and ADA positivity did not increase significantly during year 2 when both groups were receiving CT-P13: maintenance group, 49.1%, 50.4% and 46.4%; switch group, 49.3%, 49.6% and 49.6% at wk 54, 78 and 102, respectively. The number of pts with at least one AE or SAE was comparable (Table). Infusion-related reactions were seen in 10 pts (6.3%) in the maintenance group and in 4 pts(2.8%) in the switch group (p=0.1781). There were no reports of TB infections in either group. Malignancies were reported in 1 pt (ovarian cancer) in the maintenance group and in 4 pts (breast cancer, T-cell lymphoma, ovarian cancer and myeloproliferative disorder) in the switch group.
Conclusion: CT-P13 was well tolerated and effective over 2 years in pts with active RA. The efficacy and safety profiles of the maintenance group and the switch group were comparable during this extension study.
| Efficacy outcome | CT-P13 throughout study (N=151) | Switched from INX to CT-P13 in extension phase (N=142) | |
| ACR20, n (%) |
Wk 54 | 116 (76.8) | 110 (77.5) |
| Wk 78 | 108 (71.5) | 111 (78.2) | |
| Wk 102 | 109 (72.2) | 102 (71.8) | |
| ACR50, n (%) |
Wk 54 | 69 (45.7) | 71 (50.0) |
| Wk 78 | 73 (48.3) | 68 (47.9) | |
| Wk 102 | 73 (48.3) | 73 (51.4) | |
| ACR70, n (%) |
Wk 54 | 33 (21.9) | 34 (23.9) |
| Wk 78 | 37 (24.5) | 42 (29.6) | |
| Wk 102 | 37 (24.5) | 37 (26.1) | |
|
DAS28-CRP |
Baseline (BL, wk 0) | 5.8 | 5.8 |
| Δ from BL at Wk 54 | -2.4 | -2.4 | |
| Δ from BL at Wk 78 | -2.4 | −2.6 | |
| Δ from BL at Wk 102 | -2.4 | −2.5 | |
| DAS28-ESR | BL (wk 0) | 6.6 | 6.6 |
| Δ from BL at Wk 54 | -2.5 | −2.6 | |
| Δ from BL at Wk 78 | −2.6 | −2.8 | |
| Δ from BL at Wk 102 | −2.6 | −2.7 | |
|
EULAR-CRP good and moderate responses, n (%) |
Wk 54 | 135 (89.4) | 124 (87.3) |
| Wk 78 | 120 (79.5) | 122 (85.9) | |
| Wk 102 | 123 (81.5) | 109 (76.8) | |
|
EULAR-ESR good and moderate responses, n (%) |
Wk 54 | 136 (90.1) | 122 (85.9) |
| Wk 78 | 120 (79.5) | 123 (86.6) | |
| Wk 102 | 123 (81.5) | 115 (81.0) | |
| Safety outcome | CT-P13 throughout study (N=159) | Switched from INX to CT-P13 in extension phase (N=143) | |
| TEAEs, n | 226 | 180 | |
| pts with ≥1 TEAE, n (%) | 85 (53.5) | 77 (53.8) | |
| Mild | 37 (23.3) | 38 (26.6) | |
| Moderate | 39 (24.5) | 31 (21.7) | |
| Severe | 7 (4.4) | 8 (5.6) | |
| Life-threatening | 1 (0.6) | 0 | |
| Death | 1 (0.6) | 0 | |
| pts with ≥1 TESAE, n (%) | 12 (7.5) | 13 (9.1) | |
| pts with ≥1 infection, n (%) | 50 (31.4) | 47 (32.9) | |
| ADA positive, n (%) | Wk 54 | 78 (49.1) | 69 (49.3) |
| Wk 78 | 71 (50.4) | 66 (49.6) | |
| Wk 102 | 64 (46.4) | 64 (49.6) | |
| ADA, anti-drug antibodies; DAS, disease activity score; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event |
Disclosure:
D. H. Yoo,
Celltrion Inc,
5;
N. Prodanovic,
None;
J. Jaworski,
None;
P. Miranda,
None;
E. B. Ramiterre,
None;
A. Lanzon,
None;
A. Baranauskaite,
None;
P. Wiland,
None;
C. Abud-Mendoza,
None;
B. Oparanov,
None;
S. Smiyan,
Celltrion Inc,
5;
Y. Son,
Celltrion Inc,
3;
W. Park,
Celltrion Inc,
5;
U. Müller-Ladner,
Celltrion Inc,
5,
Celltrion Inc,
8.
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