Table 4.
Mean Changes of PROMs Score Between Week 48 to 54 from Baseline
| First Author (Year) | Design | Construct or Domain | Patient-Reported Outcome | Biosimilar | Reference Product | Time (Weeks) | n | Biosimilar Group | n | Reference Group | Funding |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Yoo (2013)56 | RCT | Physical function | HAQ-DI | CT-P13 | Infliximab | 54 | 302 | −0.6 (0.61) | 304 | −0.52 (0.59) | Celltrion Inc. |
| Takeuchi (2015)59 | RCT | Physical function | HAQ-DI | CT-P13 | Infliximab | 54 | 50 | −0.54 (0.59) | 51 | −0.25 (0.47) | Celltrion Inc. |
| Emery (2017)49 | RCT | Physical function | HAQ-DI | SB4 | Etanercept | 52 | 299 | −0.73 (0.58) | 297 | 0.70 (0.62) | Samsung Bioepis |
| Edwards (2019)57 | RCT | Physical function | HAQ-DI | MSB11022 | Adalimumab | 52 | 143 | −0.68 (0.68) | 145 | −0.65 (0.65) | Merck. |
| Alten (2019)29 | RCT | Physical function | HAQ-DI | PF06438179/GP1111 | Adalimumab | 54 | 280 | −0.03 (NR) | 143 | −0.02 (NR) | Sandoz and Pfizer |
| Yoo (2013)56 | RCT | QoL | SF36-PC | CT-P13 | Infliximab | 54 | 302 | 7.6 (8.1) | 304 | 6.6 (8.4) | Celltrion Inc. |
| Jorgensen (2017)58 | RCT | QoL | SF36-PC | CT-P13 | Infliximab | 52 | 206 | 0.2 (6.60) | 202 | −1.2 (6.09) | Norwegian Ministry of Health and Care Services. |
| Edwards (2019)57 | RCT | QoL | SF36-PC | MSB11022 | Adalimumab | 52 | 143 | 11.56 (9.33) | 145 | 11.15 (8.66) | Merck |
| Furst (2021)71 | RCT | QoL | SF-36 PC | CT-P17 | Adalimumab | 52 | 303 | 9.63 (7.51) | 153 | 10.7 (8.53) | Celltrion Inc. |
| Jorgensen (2017)58 | RCT | QoL | SF36 MC | CT-P13 | Infliximab | 52 | 206 | −1.3 (8.90) | 202 | −0.7 (8.90) | Norwegian Ministry of Health and Care Services. |
| Furst (2021)71 | RCT | QoL | SF-36 MC | CT-P17 | Adalimumab | 52 | 303 | 5.90 (9.58) | 153 | 7.73 (10.41) | Celltrion Inc. |
| Yoo (2013)56 | RCT | PtGA | VAS (mm) | CT-P13 | Infliximab | 54 | 302 | −30.3 (24.3) | 304 | −26.6 (27.80) | Celltrion Inc. |
| Blauvelt (2021)51 | RCT | PtGA | VAS (mm) | GP2017 | Adalimumab | 48 | 177 | −35.1 (25.7) | 176 | −39.4 (25.7) | Sandoz company |
| Jorgensen (2017)58 | RCT | PtGA | NRS (0–10) | CT-P13 | Infliximab | 52 | 206 | 0.3 (2.2) | 202 | 0.4 (0.90) | Norwegian Ministry of Health and Care Services. |
| Yoo (2013)56 | RCT | Pain | VAS | CT-P13 | Infliximab | 54 | 302 | −30.2 (23.8) | 304 | −28.4 (26.9) | Celltrion Inc. |
| Edwards (2019)57 | RCT | QoL | EuroQol Index | MSB11022 | Adalimumab | 52 | 143 | 0.21 (0.20) | 145 | 0.20 (0.18) | Merck |
| Jorgensen (2017)58 | RCT | QoL | EuroQol Index | CT-P13 | Infliximab | 52 | 206 | 0.0 (0.20) | 202 | 0.0 (0.20) | Norwegian Ministry of Health and Care Services. |
| Edwards (2019)57 | RCT | QoL | EuroQol VAS | MSB11022 | Adalimumab | 52 | 143 | 26.8 (26.15) | 145 | 22.6 (24.93) | Merck |
| Jorgensen (2017)58 | RCT | Impact of disease | RAID | CT-P13 | Infliximab | 52 | 206 | 0.20 (1.40) | 202 | 0.60 (1.20) | Norwegian Ministry of Health and Care Services. |
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.