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: SB4, a biosimilar to the reference ETN, received EU marketing authorisation in January 2016, based on the totality of evidence from pre-clinical and clinical Phase I and III studies that demonstrated similar efficacy, bioequivalence, and comparable safety and immunogenicity to ETN. There are few published data on outcomes of transition from originator to biosimilar outside the controlled setting of randomised clinical trials.
Objectives: Provide real world evidence on the outcomes of transition from ETN to SB4 in routine clinical practice.
Methods: This ongoing observational study is designed to enrol 600 subjects with RA or axSpA, who initiated SB4 as part of routine clinical practice following a minimum of 6 months treatment with a stable dose of originator ETN, at clinics in France, Germany, Italy and Spain. Data are captured from clinic records, retrospectively for 6 months prior to switch and prospectively and/or retrospectively for 6 months following switch. Outcome measures include disease score (DAS-28 for RA, BASDAI for axSpA) over time, clinical characteristics and management, and adverse events. This interim analysis (IA) describes baseline characteristics and clinical outcome 3 months post-initiation of SB4.
Results: In this interim analysis, 255 subjects have been included: 163 with RA and 92 with axSpA, both groups possibly representing longer-standing established disease; neither group experienced a clinically significant difference in disease score from baseline to 3 months post-transition, with mean individual change of 0.0 (95% CI -0.1, 0.2) and 0.4 (95% CI 0.0, 0.9) in RA and axSpA subjects respectively.
Table 1: Baseline characteristics of subjects at transition, and 3-month disease score outcomes
|
|
RA (N=163) |
AxSpA (N=92) |
||
|
|
Mean (SD) |
Q1, Q3 |
Mean (SD) |
Q1, Q3 |
|
Age in years |
60.8 (11.09) |
54.0, 69.0 |
50.7 (12.49) |
40.0, 61.0 |
|
Women n (%) |
112 (68.7) |
– |
28 (30.4) |
– |
|
Duration of disease, years |
14.3 (9.49) |
7.4, 21.0 |
12.8 (11.44) |
5.0, 16.3 |
|
Current/Ex-smoker n (%) |
37 (23.6) |
– |
32 (34.8) |
– |
|
Currently unemployed n (%) |
96 (58.9*) |
– |
24 (26.1*) |
– |
|
csDMARD** concomitant to SB4 n % |
83 (76.1***) |
– |
20 (47.6***) |
– |
|
|
Mean (SD) |
95% CI |
Mean (SD) |
95% CI |
|
DAS-28 in 6 months prior to transition to SB4 (n = 146) |
2.0 (0.92) |
1.8, 2.1 |
– |
– |
|
DAS-28 at 3 months post-transition to SB4 (n = 85) |
2.2 (1.87) |
2.0, 2.4 |
– |
– |
|
Individual change in DAS-28 from baseline to 3 months post-transition to SB4 (n= 79) |
0.0 (0.84) |
-0.1, 0.2 |
– |
– |
|
BASDAI in 6 months prior to transition to SB4 (n = 76) |
– |
– |
3.0 (2.02) |
2.5, 3.4 |
|
BASDAI at 3 months post-transition to SB4 (n = 42) |
– |
– |
3.4 (2.29) |
2.7, 4.1 |
|
Individual change in BASDAI at 3 months post-transition to SB4 (n = 37) |
– |
– |
0.4 (1.35) |
0.0, 0.9 |
DAS-28, Disease Activity Score 28; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BMI, body mass index; SD, standard deviation. *Data available for 157 and 86 subjects respectively. **conventional synthetic disease-modifying antirheumatic drug. ***Data available for 109 and 42 subjects respectively.
Conclusion: This IA provides a first insight into clinical outcomes in a contemporary cohort of EU patients with established RA and axSpA, transitioned from originator to biosimilar ETN in a study of clinical practice: data do not indicate loss of treatment effectiveness in the 3 months following transition. Subsequent to these preliminary data, the study will provide ongoing, pertinent information about 3- and 6-month outcomes in these populations, helping to inform evidence-based treatment decisions.
To cite this abstract in AMA style:
Krüger K, Selmi C, Cantagrel A, Abad MA, Freudensprung U, Rezk MF, Addison J. Benefit Study: Results of Interim Analysis of a Pan-European Observational Study to Evaluate Real-World Effectiveness of SB4 Following Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis (RA) or Axial Spondyloarthritis (AxSpA) [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/benefit-study-results-of-interim-analysis-of-a-pan-european-observational-study-to-evaluate-real-world-effectiveness-of-sb4-following-transition-from-originator-etanercept-etn-in-patients-with-rheu/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/benefit-study-results-of-interim-analysis-of-a-pan-european-observational-study-to-evaluate-real-world-effectiveness-of-sb4-following-transition-from-originator-etanercept-etn-in-patients-with-rheu/