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:
Benepali (SB4) an etanercept (ETN) biosimilar, has demonstrated comparable efficacy in randomised controlled trials. Switching patients to biosimilars has cost benefits to the national health systems (NHS). However, there is reluctance to switch patients, due to lack of real world data about its efficacy and safety.
The impetus for this study was to determine the real data trends of efficacy and safety in SB4 switching during treatment of patients with inflammatory arthritis.
Methods: Inflammatory arthritis patients, (rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AS)) switching from ETN to SB4, between Mar/17 and Oct/17, were included in this prospective observational single centre study. Disease activity scores and CRP before, and 3-6 months after switch, were calculated. Factors associated with SB4 withdrawal were recorded. DAS28, spinal VAS, BASDAI, and 66/68 swollen joint (SJ) and tender joint (TJ) counts were captured to measure efficacy. Flares were defined as a change of 1.2 points in DAS28, whilst a change of 22.55% in BASDAI was considered clinically significant.
Results:
A total of 158 inflammatory arthritis SB4 switch patients were identified (87 RA, 30 PsA and 41 AS). Patients switched from ETN after a median time of 67 (RA), 110 (PsA) and 51 (AS) months. Demographics are shown in Table 1. Disease activity measurements before, and 3-6 months after switch, are shown in Table 2. In RA, no statistical difference was found in mean DAS28 scores (p=0.344). In PsA, no significant difference was found in 68 TJ counts (p=0.565) and 66 SJ counts (p=0.475). In AS, there was no difference in mean BASDAI (p=0.893) or VAS scores (p=0.108). Median CRP level was comparable in the three groups (p=0.363). 144 (91.14%) patients continued to receive SB4 at six months. In total, 14 patients (8.9%) switched back to ETN from SB4: 4 AS (2.5%) patients had disease flare. 7 patients (4.4%) had mild adverse reaction (pruritus (2), rash (1), dizziness (1), bruising (2) and blurred vision (1)), and 3 RA patients (1.9%) had a subjective deterioration with unchanged DAS 28. All 14 patients achieved improvement after switching back to ETN.
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Table 1. Baseline demographics of Barts patient cohort |
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RA (n=87) |
PsA (n=30) |
AS (n=41) |
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Age (mean ± SD) |
61.68 ± 13.61 |
54.77 ± 13.54 |
41.90 ± 9.80 |
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Female gender, n (%) |
70 (80.5%) |
12 (29.3%) |
7 (23.3%) |
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Duration of ETN (months), median [IQR] |
67 [38.75-115] |
110 [85-115] |
51 [20.5-86.0] |
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Other biologic drug prior to ETN, n (%) |
6 (6.9%) |
1 (2.4%) |
3 (10%) |
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ETN indicates etanercept; RA, rheumatoid arthritis; PsA, psoriatic arthritis; AS, axial spondyloarthritis |
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Table 2. Disease activity scores before and 3-6 months after switch |
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ETN (mean ± SD) |
SB4 (mean ± SD) |
p-value |
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DAS28 |
2.82 ± 1.49 |
3.03 ± 1.47 |
0.344 |
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BASDAI |
3.27 ± 2.59 |
3.32 ± 2.24 |
0.893 |
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Spinal VAS |
3.22 ± 2.95 |
4.12 ± 2.99 |
0.108 |
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68 TJC |
4.26 ± 10.55 |
3.81 ± 9.76 |
0.565 |
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66 SJC |
0.78 ± 1.97 |
0.93 ± 1.64 |
0.475 |
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ETN indicates etanercept; SB4, benepali |
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Conclusion:
In this real-life observational study, biosimilar switch of SB4 was successful in over 90% of cases. The efficacy of SB4 seemed comparable to ETN and was well tolerated. In this cohort, the switch to SB4 resulted in an approximate cost saving of £370,000/yr to the NHS. It is hoped these results will encourage other centers to switch their patients from originator ETN to biosimilar SB4.
To cite this abstract in AMA style:
Alkoky H, Pakozdi A, Tahir H. Benepali Switches in Clinical Practice – a Positive Single Centre Experience [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/benepali-switches-in-clinical-practice-a-positive-single-centre-experience/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/benepali-switches-in-clinical-practice-a-positive-single-centre-experience/