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Table 2 Baseline disease characteristics (intention-to-treat population)

From: A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy

  PF-06438179/GP1111
(n = 324)
Infliximab-EU
(n = 326)
All patients
(N = 650)
RA duration, mean (SD), years 7.3 (8.6) 6.4 (6.7) 6.9 (7.7)
RF or anti-CCP antibody positive, n (%) 249 (76.9) 267 (81.9) 516 (79.4)
Swollen joint count, mean (SD) 16.1 (9.4) 16.3 (8.7) 16.2 (9.1)
Tender joint count, mean (SD) 24.7 (13.9) 25.7 (12.9) 25.2 (13.4)
hs-CRP, mg/L
 Mean (SD) 25.8 (24.3) 25.3 (28.4) 25.6 (26.4)
 Median (range) 17.9 (0.5–135.0) 16.5 (0.8–203.0) 17.4 (0.5–203.0)
DAS28-CRP, mean (SD) 6.0 (1.0) 6.0 (0.9) 6.0 (0.9)
HAQ-DI, mean (SD) 1.6 (0.6) 1.6 (0.7) NC
Prior use of one biologic drug, n (%) 7 (2.2)a 3 (0.9) 10 (1.5)a
MTX dose, mean (SD), mg/wk 14.2 (4.5)b 14.4 (4.5) 14.3 (4.5)b
Corticosteroid use, n (%) 178 (54.9) 192 (58.9) 370 (56.9)
Antimalarial drug use,c n (%) 2 (0.6) 5 (1.5) 7 (1.1)
Sulfasalazine drug use,c n (%) 2 (0.6) 2 (0.6) 4 (0.6)
  1. Abbreviations: Anti-CCP Anticyclic citrullinated peptide, DAS28-CRP Disease Activity Score in 28 joints, four components based on C-reactive protein, HAQ-DI Health Assessment Questionnaire Disability Index, hs-CRP High-sensitivity C-reactive protein, Infliximab-EU Infliximab sourced from the European Union, MTX Methotrexate, NC not calculated, RA Rheumatoid arthritis, RF Rheumatoid factor
  2. aIncludes one patient (PF-06438179/GP1111) who received more than two doses of sarilumab; this patient was not captured as biologic-experienced but was correctly recorded as having an exclusion criterion protocol deviation
  3. bTotal weekly dose of MTX was 16 mg/wk for one patient (PF-06438179/GP1111) but incorrectly recorded as 32 mg/wk; incorrect dose was the maximum value of the MTX dose range and was used for calculation of mean dose
  4. cUse of sulfasalazine and antimalarial drugs was allowed only in the original protocol, but not in subsequent protocol amendments