Change from subcutaneous to intravenous abatacept and back in patients with rheumatoid arthritis as simulation of a vacation: a prospective phase IV, open-label trial (A-BREAK)

Table 1 Demographical data (at baseline)

	Intention to treat	Per protocol
Number, number	52	49
Gender, female/male	31/21	29/20
Age, years	59.1 ± 10.8	59.3 ± 11.0
Body mass index, kg/cm	27.8 ± 5.3	27.8 ± 5.4
Disease duration, years	8.7 ± 8.2	8.3 ± 7.7
HAQ-DI, baseline	0.55 ± 0.66	0.58 ± 0.67
Tender joint count 68, mean ± SD	1.95 ± 2.97	2.11 ± 2.95
Swollen joint count 68, mean ± SD	0.55 ± 1.29	0.60 ± 1.30
Erythrocyte sedimentation rate, mm/h	11.37 ± 6.00	11.38 ± 7.0
C-reactive protein, mg/l	3.49 ± 2.00	6.28 ± 3.0
Patient’s global assessment of disease activity (VAS 0–100)	16.97 ± 13.26	15.81 ± 17.90
Patient’s global assessment of pain (VAS 0–100)	19.62 ± 16.61	18.05 ± 17.58
Physician’s global assessment of disease activity (VAS 0–100)	10.98 ± 9.28	14.33 ± 7.45
DAS-28	1.73 ± 0.72	1.82 ± 0.80
Rheumatoid factor-positive^a	62.0 %	63.8 %
ACPA-positive^a	50.0 %	51.1 %
Erosive disease^a	58.3 %	55.5 %
Pre-exposed to IV abatacept	38.5 %	34.6 %
Pre-exposed to TNF antagonists	60.1 %	53.4 %
Pre-exposed to other biologic agents	28.8 %	26.9 %
Concomitant therapy
Leflunomide	n = 20	n = 19
Leflunomide + hydroxychloroquine	n = 1	n = 1
Methotrexate^b	n = 18	n = 16
Hydroxychloroquine	n = 5	n = 5
Sulfasalazine	n = 4	n = 4
Sulfasalazine + hydroxychloroquine	n = 3	n = 3
Prednisolone dose or equivalent, mg/d	2.66 ± 3.25	2.82 ± 3.28

^aMeasured on patients with data assessable
^bMethotrexate was always applied in subcutaneous formulation
HAQ-DI Health assessment questionnaire disability Index, SD standard deviation, ACPA anti-citrullinated peptide antibodies, VAS visual analog scale, DAS-28 disease activity score in 28 joints

ISSN: 1478-6362