Background Treatment with TCZ in combination with MTX or as monotherapy in MTX-naive patients (pts) with early RA previously demonstrated improvements in signs and symptoms and in inhibition of structural joint damage in all treatment groups at 52 wks.1 Here, the PRO findings from the primary analysis at wk 52 of the 2-year, double-blind, placebo-controlled trial FUNCTION (WA19926) are reported, representing the effect of TCZ and/or MTX on health and functionality from the pt perspective.
Objectives To assess the effect of TCZ+MTX and TCZ monotherapy vs MTX on PROs in MTX-naive pts with early RA.
Methods Pts were randomized (1:1:1:1) to receive TCZ 8 mg/kg (TCZ8) + MTX, TCZ8 monotherapy, TCZ 4 mg/kg (TCZ4) + MTX, or MTX for 104 wks. Inclusion criteria included RA for ≤2 y, DAS28-ESR >3.2, MTX-naive, elevated ESR or CRP, and presence of RF or anti-CCP antibodies or radiographic erosion(s). PRO endpoints included HAQ-DI (analyzed as continuous and categorical variables), SF-36 (v2; standard 4-wk recall) Physical and Mental Component Scores (PCS, MCS), FACIT-Fatigue scores, and the ACR components Patient Global Assessment (PGA) and the Pain 100-mm Visual Analogue Scale (VAS) scores. All endpoints were analyzed as change from baseline (BL). No imputation was used for missing data. Statistical analysis of secondary endpoints followed a hierarchical chain of testing to control for type 1 error. Exploratory endpoints were not adjusted for multiplicity. 52-wk data are reported here.
Results The ITT population included 1157 pts (TCZ8+MTX, n=290; TCZ8 monotherapy, n=292; TCZ4+MTX, n=288; MTX, n=287). BL characteristics were similar in all treatment groups. TCZ8+MTX demonstrated statistically significantly greater improvement in HAQ-DI scores from BL to wks 24 and 52 than were seen in the MTX group (p=0.0011 and 0.0024, respectively; secondary endpoints, Table). Percentages of pts with the minimal clinically important difference of ≥0.22 in HAQ-DI at wk 52 were numerically higher for TCZ8+MTX than for MTX. Mean improvements in FACIT-fatigue, SF-36 PCS, SF-36 MCS, Pain VAS, and PGA VAS scores at wk 24 and wk 52 were larger for TCZ8+MTX vs MTX. Clinically relevant improvements of ≥5 for FACIT-Fatigue, >5.42 for SF-36 PCS, and >6.33 for SF-36 MCS were reached by wk 24 with TCZ8+MTX and were maintained through wk 52. Numerically higher improvements were also observed across all endpoints for TCZ4+MTX vs MTX. All PRO responses for TCZ8 monotherapy were largely similar to those seen for MTX.
Conclusions These results show that in MTX-naive pts with early RA, all treatment groups showed improvement across different PROs of pain, fatigue, physical function, and quality of life. The TCZ combination therapy groups showed consistently greater numerical improvements compared to MTX alone.
Ann Rheum Dis 2013;72(Suppl 3):63.
Disclosure of Interest G. Burmester Grant/research support: Abbott, BMS, Pfizer, Roche, UCB, Consultant for: Abbott, BMS, Medimmune, MSD, Pfizer, Roche, UCB, Speakers bureau: Abbott, BMS, MSD, Pfizer, Roche, UCB, R. Blanco Speakers bureau: Roche, MSD, AbbVie, Pfizer, M. Keiserman Grant/research support: Roche, BMS, Novartis, HGS, Pfizer, Consultant for: Amgen, Pfizer, Janssen, BMS, Speakers bureau: Abbott, Pfizer, Janssen, BMS, W. Rigby Consultant for: Roche, R. van Vollenhoven Grant/research support: AbbVie, BMS, GSK, Pfizer, Roche, UCB, Consultant for: AbbVie, Biotest, BMS, Pfizer, Roche, UCB, Vertex, S. Dimonaco Employee of: Roche, S. Grzeschik Shareholder of: Roche, Employee of: Roche, N. Mitchell Shareholder of: Roche, Employee of: Roche