Session Information
Date: Tuesday, October 23, 2018
Title: Rheumatoid Arthritis – Treatments Poster III: Biosimilars and New Compounds
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: In the United Kingdom (UK) since 2016, etanercept biosimilars (SB4) are since 2016 a first-line treatment option for the management of severe rheumatoid arthritis (RA) defined as non-response to ≥2 csDMARDs. However, real world data, including how it compares with the etanercept originator (ETN) are lacking. This study aims to compare the short-term effectiveness of etanercept originator with its biosimilar in patients with RA when used as a first biologic following csDMARDs.
Methods: This study included patients with RA registered with the British Society for Rheumatology Biologics Registers for RA (BSRBR-RA) at the point of starting either ETN or an SB4 since 2016 as their first biologic. Baseline information is collected at drug start and includes demographic and clinical data. Follow-up (FU) data are captured every 6 months and include details on therapy changes, current disease activity, and development of any adverse events. The primary outcome of this study is effectiveness as calculated by change in the 28 joint count disease activity score (DAS28). Only patients with a complete DAS28 at baseline and their first FU were included in the final analysis of this study. Hazard ratios (HR) comparing drug survival and risk of first serious adverse event (SAE) between ETN and SB4 patients were calculated using adjusted Cox regression.
Results: Between January 2016 and 27 March 2018, 322 and 855 patients starting ETN or SB4 respectively as first biologic were recruited to the BSRBR-RA. Complete DAS28 data at baseline and first FU were available for 192 ETN patients and 301 SB4 patients. Patient characteristics were similar between the 2 cohorts (Table). Only the baseline DAS28 was slightly higher in the ETN patients compared with the SB4 patients (p=0.02). After adjusting for baseline patient and clinical characteristics, no difference between groups was observed in DAS28 (p=0.1) or remission status (p=0.5) at first FU.
Thirteen (7%) and 11 (3%) ETN and SB4 patients stopped their respective treatments by the first FU. The adjusted hazard ratio for stopping ETN versus SB4 over this time period was similar (HR=1.0 (95% CI 0.4-2.5); p=0.9). Risk of SAEs over the first 6 months was also similar between groups (HR (SB4 versus ETN) =0.5 (95% CI 0.3-1.1); p=0.1), with 13 (14%) and 19 (6%) SAEs reported in ETN and SB4 patients respectively until first FU.
Conclusion: In the UK, etanercept biosimilars are now frequently used as first-line biologics in RA patients. These short-term follow-up data demonstrate in routine clinical care that SB4 appears to have comparable short-term effectiveness to ETN in terms of drug response, drug survival and safety profile.
Table
|
|
ETN |
SB4 |
p-value |
|
Number |
192 |
301 |
|
|
Female, n (%) |
129 (67%) |
226 (75%) |
0.1 |
|
Age (years) |
59 (50; 67) |
59 (51; 68) |
0.7 |
|
Disease Duration (years) |
5 (2; 13) |
5 (2; 13) |
0.3 |
|
|
|
|
|
|
Smoking |
|
|
0.5 |
|
Current |
26 (14%) |
79 (18%) |
|
|
Former |
80 (43%) |
117 (40%) |
|
|
Never |
80 (43%) |
125 (42%) |
|
|
Comorbidities |
|
|
0.2 |
|
0 |
100 (52%) |
178 (59%) |
|
|
1 |
63 (33%) |
72 (24%) |
|
|
2 |
18 (9%) |
33 (11%) |
|
|
3+ |
11 (6%) |
18 (6%) |
|
|
Baseline MTX use (%) |
101 (54%) |
181 (61%) |
0.1 |
|
HAQ (0-3) |
1.6 (0.8; 2.0) |
1.5 (1.0;2.1) |
0.3 |
|
DAS28 at baseline |
6.0 (5.4; 6.8) |
5.9 (5.2; 6.4) |
0.02 |
|
DAS28 at 6 months |
3.2 (2.3; 4.4) |
3.1 (2.1; 4.4) |
0.2 |
|
DAS28 change at 6 months |
2.6 (1.4; 3.9) |
2.9 (1.7; 3.8) |
0.5 |
|
DAS28 remission |
65 (34%) |
118 (39%) |
0.2 |
|
DAS28 low disease activity |
96 (50%) |
159 (53%) |
0.5 |
|
EULAR Good response |
95 (49%) |
159 (53%) |
0.5 |
|
Linear regression DAS28* |
Ref. |
-0.3 (-0.6; 0.0) |
0.1 |
|
Logistic regression DAS28* remission HR (95% CI) |
Ref. |
0.2 (-0.3; 0.7) |
0.5 |
To cite this abstract in AMA style:
De Cock D, Kearsley-Fleet L, Davies R, Watson K, Hyrich KL. SB4 Shows Comparable Short-Term Effectiveness to Its Etanercept Originator As First-Line Biologic Treatment for Patients with Rheumatoid Arthritis in Routine Clinical Care [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/sb4-shows-comparable-short-term-effectiveness-to-its-etanercept-originator-as-first-line-biologic-treatment-for-patients-with-rheumatoid-arthritis-in-routine-clinical-care/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/sb4-shows-comparable-short-term-effectiveness-to-its-etanercept-originator-as-first-line-biologic-treatment-for-patients-with-rheumatoid-arthritis-in-routine-clinical-care/