Table 1.
Characterization of the studies included in the systematic review (n = 6)
| Author/year | Country | Study design | Follow-up time | Population | Outcomes | Dosage | Control group (biological)1 | Exposed group (biosimilar) 1 | Total participants |
|---|---|---|---|---|---|---|---|---|---|
| Bae et al. 2017 [19] | South Korea | Phase III RCT | 48 weeks | Patients ≥ 20 years with RA3 |
Primary: ACR20 at week 24 Secondary: ACR20 at weeks 12 and 48; ACR50 and 70 at weeks 12, 24, and 48; DAS286; EULAR4 response. AEs7. ADAs8 at weeks 24 and 48 |
25 mg of HD203 and ETN administered subcutaneously twice a week with MTX once a week (7.5–25 mg/week) | ETN (n = 147) |
HD203 (n = 147) |
n = 294 |
| Emery et al. 2015–2017 [20–22] | Ukraine, United Kingdom, Bulgaria, Colombia, Czech Republic, Hungary, South Korea, Lithuania, Mexico, and Poland | Phase III RCT with open-label period | 100 weeks | Patients aged 18 to 75 years with RA3 |
Primary: ACR20 at week 24 Secondary: ACR20, 50, and 70 up to week 52; DAS286-ESR; EULAR4 response. SDAI9 and CDAI10 scores. HAQ-DI12. AEs7. ADAs8 and neutralizing antibodies at weeks 0, 2, 4, 8, 12, 16, 24, and 52 |
50 mg of SB4 and ETN self-administered subcutaneously once a week with MTX (10–25 mg/week) and folic acid (5–10 mg/week) |
ETN (n = 297, open label n = 119) |
SB4 (n = 299, open label n = 126) |
n = 596 open label n = 245 |
| Jaworski et al. 2019 [23] | Mexico, Russian Federation, the United States of America, and 13 European countries 2 | Phase III RCT | 48 weeks | Patients ≥ 18 years of age with RA34 |
Primary: DAS286-CRP up to week 24 Secondary: DAS286, EULAR4 response, ACR20/50/70 response, HAQ-DI12 in week 24 and week 48; FACIT11; AEs7. ADAs8 and neutralizing antibodies up to 48 weeks |
GP2015 50 mg and ETN self-administered subcutaneously once a week with MTX (10–25 mg/week) and folic acid (≥ 5 mg/week) | ETN (n = 166) | GP2015 (n = 175) | n = 376 |
| Matsuno et al. 2018 [24] | South Korea and Japan | Phase III RCT | 52 weeks | Patients aged between 20 and 75 years with RA3 |
Primary: DAS286-ESR at week 24 Secondary: DAS286 at weeks 12 and 52, ACR20 at weeks 12, 24, and 52, ACR50, ACR70 and EULAR4 response at weeks 12, 24, and 52. AEs up to week 54. ADAs8 and neutralizing antibodies at weeks 0, 12, 24, and 52 |
50 mg of LBEC0101 and ETN-RP5 subcutaneously once a week with MTX (7.5 to 15 mg/week in Korea and 6 to 16 mg/week in Japan, with dose approval in the country) | ETN (n = 187) | LBEC0101 (n = 187) | n = 374 |
| Matucci-Cerinic et al. 2018 [25] | Mexico, the Russian Federation, the United States of America, and 13 European countries 2 | Phase III RCT | 24 weeks | Patients ≥ 18 years with RA34 |
Primary: DAS286-CRP week 24 Secondary: EULAR4, DAS286 ACR20/50/70, HAQ-DI12, FACIT11; AEs7; ADAs8 at weeks 2, 4, 12, and 24 |
50 mg of GP2015 and ETN self-administered subcutaneously once a week with MTX (10–25 mg/week) and folic acid (≥ 5 mg/week) | ETN (n = 190) | GP 2015 (n = 186) | n = 376 |
| Park et al. 2019 [26] | South Korea and Japan | Phase III RCT, with open-label period | 100 weeks | Patients aged 41 to 65 years with RA4 |
Primary: DAS286-ESR/CRP at weeks 76 and 100 Secondary: ACR 20, 50, 70, EULAR4 response at weeks 52, 76, and 100 |
50 mg LBEC0101 and ETN self-administered subcutaneously once a week with MTX (7.5–15 mg/week) | ETN (n = 187, open label 78) | LBEC0101 (n = 187, open label 70) |
n = 374 n = 148 no open label |
1Number of participants at baseline
2Bulgaria, Czech Republic, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Serbia, Slovakia, Spain, United Kingdom
3American College of Rheumatology Criteria, 1987
4Criteria of the European American College of Rheumatology (EULAR) 2010
5Etanercept Reference Product–ETN-RP
6Disease Activity Score 28–DAS28
7Adverse Events–AEs
8Antidrug Antibodies–ADAs
9Simplified Disease Activity Index–SDAI
10Clinical Disease Activity Index–CDAI
11Functional Assessment of Chronic Illness Therapy–FACIT
12Health Assessment Questionnaire Disability Index–HAQ-DI
Source: Prepared by the authors