Figure 1

Rheumatoid arthritis. Data from the PREMIER randomised controlled trial (RCT): adalimumab plus methotrexate (ADA+MTX) versus methotrexate (MTX) in methotrexate-naive subjects with disease duration of 7–9 months. (A) Baseline scores from PREMIER (inner polygon, dark purple) versus age and gender-matched norms specific to this protocol, derived from the US population (outer polygon, light purple), as a spydergram. Differences in health-related quality of life across all domains compared with matched norms in this early rheumatoid arthritis population are easily discernable, with largest decrements in physical function (PF), role physical (RP), bodily pain (BP), social functioning (SF) and role emotional (RE). (B) Treatment-associated improvements at one and 2 years with methotrexate (MTX) monotherapy (orange) or adalimumab plus methotrexate (ADA+MTX) (blue) as concentric rings, compared with baseline and age/gender-matched norms. As each demarcation on the domain axes represents 10 points, changes are large and meet or exceed minimally clinical important differences in all domains at both timepoints in both groups. Although similar at 1 year, incremental improvements at 2 years in successful completers are largest with combination (ADA+MTX) therapy and meet or approach US normative values in five of eight domains, compared with three of eight with methotrexate monotherapy. Short Form-6D (SF-6D) scores reflect large improvements at 1 and 2 years in both treatment groups, well exceeding minimally important difference (MID) of 0.041. (C) Baseline (inner blue polygon) and matched norms (grey) versus treatment-associated changes in the RA Prevention of Structural Damage (RAPID) 1 trial at 1 year: placebo (PL) plus methotrexate (MTX) (orange) versus certolizumab (CZP) plus methotrexate (200 mg dark green; 400 mg light green polygons). Lowest scores were evident in RP and RE, followed by PF and BP, similar to other later disease populations. Improvements with active treatment are greatest in RP, PF and RE, with the largest decrements at baseline. SF-6D scores reflect large improvements in both certolizumab plus methotrexate groups versus placebo plus methotrexate, which does not meet MID of 0.041. As this protocol included subjects recruited outside north America, available US normative data offer a “benchmark” comparison only.