PHASE lll CLlNlCAL STUDY
STUDY DESlGN
N=596
Baseline to
Week 100
Phase 3 randomised double-blind multicentre study with open-label extension period (100 weeks) in RA patients from centres in the Czech Republic and Poland who continued after 52 weeks of treatment
ACR20 at Week 24 and the evaluation of long-term efficacy, safety and immunogenicity when continuing Benepali™ compared vs. switching from oETN to Benepali™.
Numbers subsequent to initial randomisation are the numbers who completed the intended study timepoints (i.e. 24 weeks, 52 weeks, and 100 weeks). Efficacy analyses were undertaken in patients receiving ≥1 dose of study drug, therefore patient numbers may be higher than shown in the study design.
Primary endpoint ACR20 at week 24
Benepali™ controls disease activity as well as oETN2,3
Adapted from: Emery P, et al. 2017.
Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept.
Secondary endpoint
Benepali™ controls disease activity as well as oETN1–3
Adapted from: Emery P, et al. 2017.
Abbreviations: DAS28, DAS28, 28-joint Disease Activity Score; oETN, originator etanercept; RA, rheumatoid arthritis; SD, standard deviation.
Benepali™ inhibits radiographic progression similarly to oETN to Week 1001–3
Adapted from: Emery P, et al. 2017.
Abbreviations: oETN, originator etanercept; mTSS, modified Total Sharp Score.
Benepali™ provides QoL benefit comparable to oETN4
Adapted from: Emery P, et al. 2017.
Abbreviations: oETN, originator etanercept; HAQ-DI, Health Assessment Questionnaire-Disability Index; QoL, quality of life; SD, standard deviation.
The immunogenicity profile of Benepali™ is comparable to that of oETN4
Adapted from: Emery P, et al. 2017.
Abbreviations: ADA, anti-drug antibody; oETN, originator etanercept.
Benepali cohort (n=126)
oETN cohort (n=119)
oETN/Benepali cohort
(switched to Benepali after 52 weeks) (n=119)
Comparable safety profile to oETN, with fewer injection-related adverse events at Week 241
| Preferred term | BenepaliTM 50 mg (n=299) n (%) |
oETN 50 mg (n=297) n (%) |
|---|---|---|
| Upper respiratory tract infection | 21 (7.0) | 15 (5.1) |
| Alanine aminotransferase increased | 15 (5.0) | 14 (4.7) |
| Nasopharyngitis | 14 (4.7) | 15 (5.1) |
| Headache | 13 (4.3) | 8 (2.7) |
| Hypertension | 10 (3.3) | 10 (3.4) |
| Aspartate aminotransferase increased | 7 (2.3) | 8 (2.7) |
| Viral infection | 7 (2.3) | 5 (1.7) |
| lnjection site erythema | 6 (2.0) | 33 (11.1) |
| Rheumatoid arthritis | 6 (2.0) | 9 (3.0) |
| Bronchitis | 6 (2.0) | 6 (2.0) |
| Diarrhoea | 5 (1.7) | 7 (2.4) |
| Pharyngitis | 4 (1.3) | 8 (2.7) |
| Urinary tract infection | 4 (1.3) | 7 (2.4) |
| Lymphocyte count decreased | 4 (1.3) | 6 (2.0) |
| Cough | 3 (1.0) | 10 (3.4) |
| Erythema | 2 (0.7) | 10 (3.4) |
| Dizziness | 2 (0.7) | 7 (2.4) |
| lnjection site rash | 2 (0.7) | 6 (2.0) |
| lnjection site reaction | 1 (0.3) | 7 (2.4) |
Adapted from: Emery P, et al. 2017.
Abbreviations: oETN, originator etanercept.