Session Information
Date: Monday, November 9, 2015
Title: Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy III: Biosimilars
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: SB2 is developed as
a biosimilar of the infliximab reference product (INF). 30-week efficacy and
safety results from a randomized phase III study were recently presented1.
The objective of this study is to compare the long-term efficacy, safety and immunogenicity
between SB2 and INF, including progression of radiographic damage, up to 54
weeks.
Methods: This study is a
randomized, double-blind phase III study.
Patients with moderate to severe RA (1987 ACR criteria) despite methotrexate (MTX) were randomized in a 1:1
ratio to receive either SB2 or INF (3 mg/kg). Dose increments were allowed
after week 30 up to 7.5 mg/kg. Dosing occurred at week 0, 2, 6 and then every 8
weeks until week 46. Efficacy, safety and immunogenicity outcomes were assessed
up to week 54 at each visit. Radiographic damage was assessed by the change of
modified total sharp score (mTSS) from baseline to
week 54.
Results: A total of 584
patients were randomized to either SB2 (N=291) or INF (N=293) and 452 patients completed
54 weeks of treatment (SB2 N=227, INF N=225). The ACR20 response rate at week
54 in the full analysis set (FAS) was 50.7% in SB2 and 52.6% in INF (Figure 1).
The ACR50 and ACR70 responses were also similar (32.1%
vs. 29.7%; 18.3% vs. 17.7%, Figure 1). Other secondary efficacy parameters at week
54 such as DAS28 or EULAR response were similar between the two treatment
groups. The change of mTSS was comparable between the two treatment groups (mean
change: 0.38 in SB2 vs. 0.37 in INF; cumulative probability plot is shown in Figure
2). The safety profile of SB2 was generally comparable to that of INF (Table 1).
The overall anti-drug antibody positivity up to week 54 was 62.4% in SB2 and
57.5% in INF (p-value = 0.270).
Conclusion: Up to 54 weeks, SB2 showed comparable long-term efficacy, safety and immunogenicity
to those of INF and well tolerated. In particular, radiographic progression was
comparable between SB2 and INF at 54 weeks.
Reference
1. Choe
JY et al. EULAR 2015, SAT0152
Figure 1. ACR20, 50, 70 Response Rates at Week 54 in
the Full Analysis Set (FAS)*
*FAS follows
the intention-to-treat (ITT) principle and includes all patients with at least
1 dose of the study drug. Patients without response at week 54 were considered
as non-responders.
Figure 2. Cumulative Probability of Change in Modified Total Sharp Score (mTSS) from baseline at Week 54
|
Table 1. Safety Profile of the Study Population up to 54 weeks
|
||||
|
Number of patients with |
SB2 (N=290)* |
INF (N=293) |
||
|
n |
% |
n |
% |
|
|
At least 1 TEAE |
179 |
61.7 |
191 |
65.2 |
|
At least 1 SAE |
29 |
10.0 |
31 |
10.6 |
|
Total infections |
85 |
29.3 |
110 |
37.5 |
|
Serious infections |
9 |
3.1 |
6 |
2.0 |
|
Tuberculosis |
1 |
0.3 |
1 |
0.3 |
|
Infusion-related reaction |
17 |
5.9 |
15 |
5.1 |
|
Malignancy |
2 |
0.7 |
0 |
0.0 |
|
Death |
0 |
0 |
1 |
0.3 |
|
SAE: serious adverse event; TEAE: treatment-emergent adverse event. *1 patient dropped out before receiving at least 1 dose of SB2. |
||||
To cite this abstract in AMA style:
Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH, Smolen JS. A Randomized, Double-Blind, Phase III Study Comparing SB2, an Infliximab Biosimilar, to the Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 54-Week Results [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/a-randomized-double-blind-phase-iii-study-comparing-sb2-an-infliximab-biosimilar-to-the-infliximab-reference-product-remicade-in-patients-with-moderate-to-severe-rheumatoid-arthritis-despi/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-randomized-double-blind-phase-iii-study-comparing-sb2-an-infliximab-biosimilar-to-the-infliximab-reference-product-remicade-in-patients-with-moderate-to-severe-rheumatoid-arthritis-despi/