Table 1.
Patient demographics at baseline and disease activity at baseline and week 24a
| SB5 group (n = 271) | ADA overall group (n = 273) | ADA/SB5 group (n = 125) | ADA/ADA group (n = 129) | |||||
|---|---|---|---|---|---|---|---|---|
| Demographics at baseline | ||||||||
| Age, years | 49.8 ± 12.7 | 52.5 ± 11.9 | 51.7 ± 11.3 | 52.8 ± 12.3 | ||||
| Sex, no. (%) | ||||||||
| Female | 217 (80.1) | 224 (82.1) | 105 (84.0) | 103 (79.8) | ||||
| Male | 54 (19.9) | 49 (17.9) | 20 (16.0) | 26 (20.2) | ||||
| BMI, kg/m2 | 26.2 ± 4.8 | 27.0 ± 5.1 | 27.2 ± 5.3 | 26.9 ± 5.0 | ||||
| Disease duration, years | 5.4 ± 4.4 | 5.5 ± 4.3 | 5.3 ± 4.1 | 5.6 ± 4.5 | ||||
| MTX dose, mg/week | 15.1 ± 4.6 | 15.4 ± 4.4 | 15.4 ± 4.5 | 15.2 ± 4.4 | ||||
| Duration of MTX use, months | 39.5 ± 38.4 | 37.8 ± 34.9 | 38.3 ± 33.8 | 39.5 ± 37.2 | ||||
| RF positive, no. (%) | 203 (74.9) | 185 (67.8) | 80 (64.0) | 94 (72.9) | ||||
| Disease activity at baseline | ||||||||
| Swollen joint count | 15.8 ± 8.0 | 15.5 ± 7.5 | 14.5 ± 6.4 | 16.3 ± 8.3 | ||||
| Tender joint count | 23.9 ± 11.7 | 24.1 ± 10.8 | 23.8 ± 10.5 | 24.3 ± 11.3 | ||||
| HAQ DI score | 1.3 ± 0.6 | 1.4 ± 0.6 | 1.4 ± 0.6 | 1.4 ± 0.7 | ||||
| DAS28‐ESR | 6.5 ± 0.7 | 6.5 ± 0.71 | 6.5 ± 0.6 | 6.4 ± 0.8 | ||||
| CRP, mg/liter | 11.5 ± 19.0 | 12.6 ± 19.0 | 13.0 ± 20.8 | 11.9 ± 15.7 | ||||
| ESR, mm/hour | 39.6 ± 13.3 | 39.6 ± 13.9 | 40.5 ± 14.3 | 39.3 ± 14.0 | ||||
| Physician's global assessment, 0–100‐mm VAS | 59.8 ± 16.9 | 60.6 ± 15.4 | 60.6 ± 14.7 | 61.0 ± 16.1 | ||||
| Patient's global assessment, 0–100‐mm VAS | 58.5 ± 20.3 | 59.4 ± 18.7 | 59.1 ± 18.0 | 59.9 ± 19.6 | ||||
| Patient's assessment of pain, 0–100‐mm VAS | 59.2 ± 20.7 | 60.8 ± 19.7 | 61.0 ± 19.6 | 60.6 ± 20.0 | ||||
| ACR‐N | NA | NA | NA | NA | ||||
| Disease activity at week 24 | ||||||||
| Swollen joint count | 3.2 ± 4.5 | 3.3 ± 4.9 | 3.3 ± 5.0 | 3.3 ± 4.7 | ||||
| Tender joint count | 7.4 ± 7.4 | 8.4 ± 9.6 | 8.1 ± 9.1 | 8.4 ± 10.0 | ||||
| HAQ DI score | 0.8 ± 0.6 | 0.9 ± 0.6 | 0.9 ± 0.6 | 0.9 ± 0.6 | ||||
| DAS28‐ESR | 3.7 ± 1.2 | 3.8 ± 1.4 | 3.7 ± 1.4 | 3.8 ± 1.3 | ||||
| CRP, mg/liter | 5.6 ± 10.3 | 5.8 ± 8.6 | 6.1 ± 9.9 | 5.3 ± 6.7 | ||||
| ESR, mm/hour | 18.9 ± 14.8 | 19.0 ± 14.2 | 18.6 ± 12.8 | 19.6 ± 15.5 | ||||
| Physician's global assessment, 0–100‐mm VAS | 23.6 ± 16.4 | 25.0 ± 17.8 | 25.0 ± 18.0 | 24.0 ± 17.1 | ||||
| Patient's global assessment, 0–100‐mm VAS | 33.7 ± 21.7 | 35.1 ± 22.0 | 36.7 ± 22.4 | 33.1 ± 21.4 | ||||
| Patient's assessment of pain, 0–100‐mm VAS | 35.6 ± 21.8 | 37.0 ± 23.3 | 38.6 ± 23.4 | 34.7 ± 22.9 | ||||
| ACR‐N | 40.2 ± 28.7 | 39.6 ± 29.2 | 38.4 ± 29.6 | 41.5 ± 28.8 | ||||
Except where indicated otherwise, values are the mean ± SD. SB5 group = patients randomized to receive the biosimilar SB5 at week 0; adalimumab (ADA) overall group = patients randomized to receive reference ADA at week 0; ADA/SB5 group = patients receiving ADA rerandomized to switch to SB5; ADA/ADA group = patients receiving ADA rerandomized to continue ADA; BMI = body mass index; MTX = methotrexate; RF = rheumatoid factor; HAQ DI = Health Assessment Questionnaire disability index; DAS28‐ESR = Disease Activity Score in 28 joints using the erythrocyte sedimentation rate; CRP = C‐reactive protein; VAS = visual analog scale; ACR‐N = American College of Rheumatology index of improvement in rheumatoid arthritis; NA = not applicable.