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:
Biosimilar contains a version of active substance similar of an already approved biological agent in terms of quality, characteristic, biological activity, safety and efficacy. The price of biosimilars is often less than their original biologic agents. Many healthcare providers have the option of switching patients from original biologic agents to biosimilars to reduce cost.The Purpose of this study was to compare the effectiveness and safety of the Etanercept Biosimilar (Benepali) with Originator (Enbrel) after switching in patients with rheumatoid arthritis (RA) in Wales, United Kingdom
Methods:
A retrospective study was conducted across all hospitals within Wales in the United Kingdom as a national audit. Patients switched from Enbrel to Benepali were identified. Efficacy was assessed by change in DAS28CRP disease activity status before and after switching. We included both biologic naïve and experienced patients.
Results:
±±9.2 yrs. Enbrel was used as first line biologic treatment in 105 patients, second line in 14 and third line in 1 patient. Rheumatoid Factor and ACPA were positive in 72% and 63% of patients respectively. Most patients were taking concomitant DMARDs (96/120). Only 24 patients were not taking any conventional DMARDs, however, 8 patients were treated with prednisolone. Methotrexate was the most commonly used DMARD. After switching to biosimilar, 47 (39.1%) patients out of 120 patients had increase in their DAS28CRP score of which 27 patients (22.5%) moved from a lower disease state to a higher disease state (Table). Out of 102 patients who were in remission at the time of switching, 17 (17%) patients developed low, moderate or high diseases activity. At baseline, 18 patients were in low or moderate disease activity, 10 (56%) moved to moderate or high disease activity. Amongst 47 patients who had increase in DAS28CRP, 18 reported disease flares. Most flares occurred within the first 4 months of switching (16 out of 18 flares). Half of these patients (9 out of 18) were switched back to Enbrel. 13 adverse reactions were noted after switching to on Benepali, which included 5 infections (chest and urinary), 4 others (shortness of breath, oral ulcerations, eczema, neutropenia 1 patient each) and 4 unspecified.
Table
|
After Switching |
||||
|
Baseline N=120 |
Remission |
LDA |
MDA |
HAD |
|
Remission (n=102) |
85 |
8 |
8 |
1 |
|
LDA (n=7) |
0 |
0 |
6 |
1 |
|
MDA (n=11) |
0 |
0 |
8 |
3 |
|
HAD (n=0) |
0 |
0 |
0 |
0 |
LDA –low diseases activity MDA-Moderate diseases activity HDA-High diseases activity
Conclusion:
After switching from Enbrel to biosimilar Benepali, many patients experience increase in disease activity, this is more likely if patients are not in disease remission at the time of switching suggesting that these may be due to natural fluctuation or spontaneous disease flares in patients with unstable disease. Only 18 (15%) patients reported disease flare and 9 (8%) patients had to switch back to Enbrel.
To cite this abstract in AMA style:
Rajamani K, Choy E. Change in Disease Activity after Switching Etanercept (originator) to Biosimilar (Benepali) Is Associated with Active Disease at Baseline [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/change-in-disease-activity-after-switching-etanercept-originator-to-biosimilar-benepali-is-associated-with-active-disease-at-baseline/. Accessed .« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/change-in-disease-activity-after-switching-etanercept-originator-to-biosimilar-benepali-is-associated-with-active-disease-at-baseline/