Table 2. . randomized phase 3 trials with adalimumab biosimilars, in which their clinical activity was compared with originator adalimumab (Humira®).
| Author | Investigated biosimilar | Study design | Patients | n | Duration, weeks | Primary end point | Primary end point relative to Humira® | Ref. |
|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | ||||||||
| Cohen et al. 2017 | ABP 501 (Amjevita®/ Amgevita®) | R, DB, P | Moderate to severe active RA on MTX | 526 | 24 | ACR20 at week 24 | RR 1.039 (90% CI 0.954, 1.133) | [37] |
| Fleischmann et al. 2018 | PF-06410293 (Amsparity®) | R, DB, P | Active RA on MTX | 597 | 78 | ACR20 at week 12 | Adjusted difference -2.98% (95% CI -10.38, 4.44; 90% CI -9.25, 3.28) | [39] |
| Weinblatt et al. 2018 | SB5 (Imraldi®/ Hadlima®) | R, DB, P | Moderate to severe active RA on MTX | 544 | 52 | ACR20 at week 24 | Adjusted difference 0.1% (95% CI -7.83, 8.13), in PPS (n = 476) | [46] |
| Genovese et al. 2019 | FKB327 (Hulio®) | R, DB, P | Active RA on MTX | 728 | 24–54 | ACR20 at week 24 | Adjusted difference -1.6%† (95% CI -7.9, 4.7; 90% CI -7.3, 3.6), in FAS (n = 721) | [40] |
| Kay et al. 2021 | CT-P17 (Yuflyma®) | R, DB, P | Active RA on MTX | 648 | 24–52 | ACR20 at week 24 | Adjusted difference 0%‡ (95% CI -5.94, 5.94) | [42] |
| Plaque psoriasis | ||||||||
| Papp et al. 2017 | ABP 501 (Amjevita®/ Amgevita®) | R, DB, P | Moderate to severe psoriasis (PASI ≥12), not responsive to or tolerant of conventional systemic therapy | 350 | 16–52 | % change from baseline PASI score at week 16 | LSM difference -2.18% (95% CI -7.39, 3.02) | [44] |
| Blauvelt et al. 2018 | GP2017 (Hyrimoz®) | R, DB, P | Moderate to severe psoriasis (PASI ≥12), previously treated with phototherapy or conventional systemic therapy | 465 | 51 | PASI75 at week 16 | Adjusted difference 1.8% (95% CI -7.46, 11.15) in PPS (n = 393) | [36] |
| Hercogová et al. 2020 | MSB11022 (Idacio®) | R, DB, P | Moderate to severe psoriasis (PASI ≥12), previously treated with phototherapy or conventional systemic therapy | 443 | 52 | PASI75 at week 16 | Difference –1.9% (95% CI -7.82, 4.07) in PPS (n = 394) | [41] |
| Feldman et al. 2021 | AVT02 (Hukyndra®) | R, DB, P | Moderate to severe psoriasis (PASI ≥12), not responsive to or tolerant of ≥1 non-biologic systemic therapy | 413 | 52 | % change from baseline PASI score at week 16 | LSM difference 2.3% (95% CI -1.34, 5.88; 90% CI -0.76, 5.29) in FAS (n = 412) | [38] |
†
Crude difference in proportions calculated from data reported in the paper, namely ACR20 response rate of 74.1% with FKB327 and 75.7% with adalimumab.
‡
Crude difference in proportions calculated from data reported in the paper, namely ACR20 response rate of 82.7% in each group.
ACR20: Proportion of patients achieving a 20% improvement in American College of Rheumatology criteria; CI: Confidence interval; DB: Double-blind; FAS: Full analysis set; LSM: Least squares mean; MTX: Methotrexate; P: Parallel; PASI: Psoriasis Area and Severity Index; PPS: Per protocol set; R: Randomized; RA: Rheumatoid arthritis; RR: Risk ratio.