Introduction
Methods
Study design
Endpoints
Statistical analysis
Results
Patient population
Characteristics of the study population and baseline features before the introduction of the current biological treatment
Total group (n = 332) | Standard care group (n = 192) | Dose reduction group (n = 140) | p value | |
---|---|---|---|---|
Patient age in 2017, years (mean ± SD) | 57.83 ± 15.12 | 55.70 ± 15.78 | 60.74 ± 13.69 | 0.02 |
Patient age at the RA diagnostic, years (mean ± SD) | 40.56 ± 13.89 | 38.72 ± 13.99 | 43.08 ± 13.39 | 0.04 |
Patient age at the introduction of the evaluated biologic treatment, years (mean ± SD) | 51.16 ± 14.33 | 49.99 ± 14.82 | 52.77 ± 13.50 | |
Disease duration at the introduction of the first sDMARD, years (mean ± SD) | 2.10 ± 5.12 | 2.05 ± 5.21 | 2.17 ± 5.02 | |
Disease duration at the introduction of the first bDMARD, years (mean ± SD) | 8.33 ± 9.13 | 9.06 ± 9.62 | 7.34 ± 8.35 | |
Disease duration at the introduction of the evaluated bDMARD, years (mean ± SD) | 11.09 ± 9.99 | 12.08 ± 10.60 | 9.73 ± 8.95 | 0.034 |
Women, n (%) | 259 (78%) | 143 (74.5%) | 116 (82.9%) | |
Anticyclic citrullinated peptide antibody positive, n (%) | 221 (73.9%) | 123 (70.3%) | 98 (79%) | |
Rheumatoid factor positive, n (%) | 252 (77.3%) | 137 (72.8%) | 115 (83.3%) | 0.04 |
Presence of erosion, n (%) | 290 (87.3%) | 166 (86.5%) | 124 (88.6%) | |
Smoking status, n (%) | 52 (17%) | 28 (16,4%) | 24 (17.6%) | |
Tender joint count (0–68 scale) at the introduction of the evaluated bDMARD (mean ± SD) | 11.02 ± 8.8 | 11.14 ± 8.52 | 10.85 ± 9.33 | |
Swollen joint count (0–68 scale) at the introduction of the evaluated bDMARD (mean ± SD) | 8.56 ± 5.77 | 8.41 ± 6.06 | 8.76 ± 5.36 | |
Health assessment questionnaire (0–3 scale) at the introduction of the evaluated bDMARD (mean ± SD) | 1.45 ± 0.71 | 1.52 ± 0.70 | 1.34 ± 0.71 | 0.048 |
Patient global assessment (0–100 mm) at the introduction of the evaluated bDMARD (mean ± SD) | 64.29 ± 23.70 | 67.11 ± 22.33 | 60.09 ± 25.14 | 0.024 |
C-reactive protein (mg/dl) at the introduction of the evaluated bDMARD (mean ± SD) | 2.61 ± 7.19 | 2.71 ± 9.08 | 2.49 ± 3.21 | |
Disease activity score in 28 joints at the introduction of the evaluated bDMARD (mean ± SD) | 4.82 ± 1.02 | 4.83 ± 0.98 | 4.80 ± 1.09 | |
Glucocorticoids intake at the introduction of the evaluated bDMARD, n (%) | 173 (53.2%) | 99 (52.1%) | 74 (54.8%) | |
Methotrexate intake at the introduction of the evaluated bDMARD, n (%) | 258 (77.7%) | 141 (73.8%) | 117 (86.7%) | 0.005 |
Comparison of the DAS28-CRP between the 2 groups
Analysis according to the different types of received biological treatments, dose reduction and relapses
Number of bDMARDs received | Total group % (n) | Standard care group % (n) | Dose reduction group % (n) |
---|---|---|---|
1 | 53.3 (177) | 49.5 (96) | 57.6 (81) |
2 | 29.5 (98) | 32.1 (61) | 26.6 (37) |
3 | 8.4 (28) | 8.3 (16) | 8.5 (12) |
4 | 5.7 (19) | 6.3 (12) | 5.0 (7) |
5 | 2.4 (8) | 2.6 (5) | 2.2 (3) |
6 | 0.6 (2) | 1.1 (2) | 0 (0) |
Total | 100 (332) | 100 (192) | 100 (140) |
Economic impact of reducing the dose of biological treatments
bDMARD | Standard care group n (%) | Annual cost per patient in euros (€) for the standard care group | Dose reduction group n (%) | Annual cost per patient in euros (€) for the dose reduction group |
---|---|---|---|---|
ABA | 11 (5.7) | 12,979 | 11 (7.9) | 8643.5 |
ADA | 14 (7.3) | 12,525 | 28 (20.0) | 7175.03 |
CZP | 5 (2.6) | 11,740.2 | 0 (0) | Not available |
ETN | 29 (15.1) | 9328.6 | 30 (21.4) | 5580.04 |
GOL | 19 (9.9) | 12,703.08 | 3 (2.1) | Not available |
IFX | 68 (35.41) | 7290 | 28 (20) | 6146.5 |
RTX | 17 (8.85) | 8784 | 18 (12.85) | 4675.03 |
TOC | 29 (15.1) | 12,773.7 | 22 (15.71) | 9487.7 |
192 | 140 |