Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis

Table 2 Summary of analyses of ACR20 at week 22 using non-parametric analysis of covariance method

Analysis population	RD (ABP 710 – RP) of ACR20 (%)
Analysis population	Point estimate	90% CI	95% CI
ITT analysis set with NRI	7.18	0.75, 13.62	− 0.49, 14.85
ITT analysis set with LOCF imputation	6.09	− 0.26, 12.44	− 1.48, 13.66
ITT analysis set, as observed	6.52	0.04, 12.99	− 1.20, 14.23
Per protocol analysis set	8.40	1.73, 15.06	0.45, 16.34

Abbreviations: ACR20 20% improvement in American College of Rheumatology core set measurements, CI confidence interval, ITT intent-to-treat, LOCF last observation carried forward, NRI nonresponder imputation, RD response difference, RP reference product
Note: The Mantel-Haenszel estimate and corresponding CIs for the RD were estimated by the non-parametric analysis of covariance method using the SAS NParCov4 macro with strata determined by IXRS values of the stratification factors geographic region (Europe, North America combined with Asia Pacific) and prior biologic use and adjustment for baseline covariates (tender joint count, swollen joint count, Subject’s Global Health Assessment, Investigator’s Global Health Assessment, Subject’s Assessment of Disease-related Pain, HAQ-DI, C-reactive protein, age, use of oral corticosteroid, use of non-steroidal anti-inflammatory drugs, body mass index categories of < 25, 25–30, and ≥ 30, and methotrexate dose)

ISSN: 1478-6362