Table 3.
Mean Changes of PROMs Score Between Week 24 to 30 from Baseline
| First Author (Year) | Design | Construct or Domain | PRO | Biosimilar | Reference Product | Time (Weeks) | n | Biosimilar Group | n | Reference Group | Funding |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Yoo (2013)56 | RCT | Physical function | HAQ-DI | CT-P13 | Infliximab | 30 | 302 | −0.6 (0.6) | 304 | −0.50 (0.60) | Celltrion Inc. |
| Takeuchi (2015)59 | RCT | Physical function | HAQ-DI | CT-P13 | Infliximab | 30 | 50 | −0.47 (0.51) | 51 | −0.36(0.47) | Celltrion Inc. |
| Edwards (2019)57 | RCT | Physical function | HAQ-DI | MSB11022 | Adalimumab | 24 | 143 | −0.61 (0.60) | 145 | −0.62 (0.58) | Merck. |
| Alten (2019)29 | RCT | Physical function | HAQ-DI | PF06438179/GP1111 | Adalimumab | 30 | 280 | −0.6 (NR) | 143 | −0.6 (NR) | Sandoz and Pfizer |
| Matucci-Cerinic (2018)54 | RCT | Physical function | HAQ-DI | GP2015 | Etanercept | 24 | 186 | −0.57 (NR) | 190 | −0.67 (NR) | Sandoz |
| Yoo (2013)56 | RCT | QoL | SF36-PC | CT-P13 | Infliximab | 30 | 302 | 7.1 (7.9) | 304 | 6.5 (7.6) | Celltrion Inc. |
| Edwards (2019)57 | RCT | QoL | SF36-PC | MSB11022 | Adalimumab | 24 | 143 | 10.23 (9.03) | 145 | 9.99 (8.29) | Merck |
| Kay (2021)70 | RCT | QoL | SF36-PC | CT-P17 | Adalimumab | 24 | 309 | 7.86 (7.41) | 312 | 8.21 (8.01) | Celltrion Inc. |
| Kay (2021)70 | RCT | QoL | SF36-MC | CT-P17 | Adalimumab | 24 | 309 | 5.87 (9.84) | 312 | 6.58 (9.74) | Celltrion Inc. |
| Yoo (2013)56 | RCT | PtGA | VAS | CT-P13 | Infliximab | 30 | 302 | −28.5 (25.9) | 304 | −27 (25.60) | Celltrion Inc. |
| Blauvelt (2021)51 | RCT | PtGA | VAS | GP2017 | Adalimumab | 24 | 177 | −38.2 (24.1) | 176 | −41.5 (23.9) | Sandoz company |
| Yoo (2013)56 | RCT | Pain | VAS (mm) | CT-P13 | Infliximab | 30 | 302 | −29.5 (25.5) | 304 | −27.8 (24.6) | Celltrion Inc. |
| Blauvelt (2021)51 | RCT | Pain | VAS (mm) | GP2017 | Adalimumab | 24 | 177 | −38.5 (25.7) | 176 | −41.4 (24.2) | Sandoz company |
| Yoo (2013)56 | RCT | QoL | SF36-MC | CT-P13 | Infliximab | 30 | 302 | 7.1 (10.0) | 304 | 6.6 (10.4) | Celltrion Inc. |
| Kay (2021)70 | RCT | QoL | SF36-MC | CT-P17 | Adalimumab | 24 | 309 | 5.87 (9.84) | 312 | 6.58 (9.74) | Celltrion Inc. |
| Blauvelt (2021)51 | RCT | Fatigue | FACIT | GP2017 | Adalimumab | 24 | 177 | 27.98 (9.20) | 176 | 38.8 (9.30) | Sandoz company |
| Matucci-Cerinic (2018)54 | RCT | Fatigue | FACIT | GP2015 | Etanercept | 24 | 186 | 9.45 (NR) | 190 | 11.8 (NR) | Sandoz |
| Edwards (2019)57 | RCT | QoL | EuroQol Index | MSB11022 | Adalimumab | 24 | 143 | 0.19 (0.21) | 145 | 0.18 (0.18) | Merck |
| Edwards (2019)57 | RCT | QoL | EuroQol VAS | MSB11022 | Adalimumab | 24 | 143 | 24.1(26.99) | 145 | 18.6 (26.58) | Merck |
Abbreviations: RCT, randomized clinical trial; PtGA, Patient Global Assessment; QoL, quality of life; SF-36-PC, SF-36 physical component; SF-36-MC, SF-36 mental component; VAS, visual analog scale; NRS, numeric rating scale; RAID, rheumatoid arthritis impact of disease; NR, not reported.