Table 1 Characterization of the studies included in the systematic review (n = 6)

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 [20,21,22]

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