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Abstract Number: 2533

Switching Patients with Arthritis from Etanercept (Enbrel) to the Biosimilar Drug, Benepali: A Single- Center Retrospective Observational Study

Anastasia- Vasiliki Madenidou1, Andrew Jeffries2, Sneha Varughese2, Stephen Jones2, Helen Veevers2, Hanadi Sari- Kouzel2 and Chandini Rao2, 1Rheumatology, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom, 2Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Biologics, Biosimilars and etanercept

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Session Information

Date: Tuesday, October 23, 2018

Session 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, the etanercept biosimilar, is licenced in the UK for the same indications as the reference product, Enbrel.

In 2016, the Rheumatology Department at Blackpool Teaching Hospitals, after informing all the patients on Enbrel about Benepali, switched the patients that gave consent.

A proportion of these patients requested a switch back to Enbrel and therefore we aimed to investigate the reasons for Benepali withdrawal and if the loss of effect (LOE) is reflected in change of disease activity measures.

Methods: We included all the patients switched to Benepali from July 2016 to April 2018, identified from the departmental biologics database. Data were collected from patientsÕ records.

Baseline characteristics associated with Benepali withdrawal were explored by multivariate logistic regression analysis stratified by diagnosis (RA, SpA, PsA) and included age, gender, duration of disease, co- treatment with DMARDs, concomitant Methotrexate, number of biological DMARDs (bDMARDs) before Enbrel, duration on Enbrel, number of swollen and tender joints, baseline ESR and CRP; only for RA: seropositivity for RF and / or ACPA, DAS- 28 before any bDMARD, baseline DAS-28 and Patient Global Score (PGS); only for SpA: HLA- B27 status, BASDI before any bDMARD, baseline BASDI and pain Visual Analogue Score (VAS) and only for PsA: Baseline Patient (PtGA) and Physician Global Assessment (PGA).

Wilcoxon signed-rank test was performed to compare the various expressions of disease activity (DAS- 28 and PGS for RA, BASDI and pain VAS for SpA, PtGA and PGA for PsA, ESR, CRP) before switching to Benepali and before Benepali withdrawal in patients with LOE.

Results: A total of 72 patients on Enbrel were switched to Benepali, of which 19 (26,4%) switched back to Enbrel after 6 months [interquartile range (IQR) 3.5- 10] on the biosimilar product (Table). All the 19 patients had remained on Enbrel until the time of data analysis [follow- up period: 12 months (IQR 7.5- 15.5)].

The reasons of withdrawal were LOE (58%), adverse events (32%), infection (5%) and difficulty using the pen device (5%). In RA, the duration on Enbrel was associated with Benepali withdrawal [OR 1.43 (95% CI 1.02, 2.00)] and no statistically significant factors were found in SpA and PsA.

For RA, LOE is reflected in the DAS- 28 increase (2.99), PGS increase (40 mm), increase in tender joints (3.5) and CRP increase (2 mg/dl) (all p <0.05), whereas for SpA and PsA there was no statistically significant change in disease activity measures.

Conclusion: The majority (73,6%) had a good response to Benepali, which is in keeping with the current evidence. In RA, LOE is reflected only in the subjective measures, except for CRP. Interestingly, all the patients switching back to Enbrel, stayed on this treatment, which may indicate other contributing factors in withdrawal not identified by this study, due to the limitation of the small sample size.

Table: Baseline characteristics of patients switched to Benepali

Rheumatoid arthritis

Axial Spondyloarthropathy

Psoriatic arthritis

Number, n

36

23

13

Female, n (%)

27 (75%)

7 (30%)

6 (46%)

Age, years

62 (56- 77)

56 (46- 66)

54 (51.5- 67.5)

Duration on Etanercept (Enbrel) before switching to Benepali, years

3.8 (2.3- 7.5)

5.2 (3.1- 7.5)

2.8 (2.3- 6.6)

Duration of disease before switching to Benepali, years

15 (8.2- 21)

29 (17.3- 38)

17 (12.5- 26.5)

Co- treatment with DMARDs, n (%)

32 (89%)

2 (8,7%)

9 (69,2%)

Concominant Methotrexate, n (%)

26 (72%)

1 (4,3%)

6 (46,2%)

On other bDMARDs before Enbrel, n (%)

8 (22.2%)

4 (17.4%)

2 (15.4%)

DAS- 28 before any bDMARD

6.18 (5.72- 6.71)

NA

NA

DAS- 28 before switching to Benepali

2.87 (1.89- 3.73)

NA

NA

BASDI before any bDMARD

NA

7.01 (6.25- 8.68)

NA

BASDI before switching to Benepali

NA

2.95 (1.94- 4.85)

NA

ESR before switching to Benepali, mm/hr

12.50 (6.00- 19.75)

6.00 (2.00- 9.00)

7.00 (5.00- 26.50)

CRP before switching to Benepali, mg/dl

2.00 (1.00- 5.00)

4.00 (1.00- 7.90)

2.00 (1.00- 9.50)

Numbers are medians (interquartile ranges) unless otherwise stated

bDMARDs= biological DMARDs, NA= Not Applicable


Disclosure: A. V. Madenidou, None; A. Jeffries, Pfizer, Inc., 9; S. Varughese, None; S. Jones, None; H. Veevers, None; H. Sari- Kouzel, None; C. Rao, Pfizer, Inc., 9.

To cite this abstract in AMA style:

Madenidou AV, Jeffries A, Varughese S, Jones S, Veevers H, Sari- Kouzel H, Rao C. Switching Patients with Arthritis from Etanercept (Enbrel) to the Biosimilar Drug, Benepali: A Single- Center Retrospective Observational Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/switching-patients-with-arthritis-from-etanercept-enbrel-to-the-biosimilar-drug-benepali-a-single-center-retrospective-observational-study/. Accessed March 8, 2021.
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