Low-dose modified-release prednisone in axial spondyloarthritis: 3-month efficacy and tolerability

Figures & data

Table 1 Demographic and clinical characteristics of the study population at baseline

	Overall population (n=57)	Low-active SpA (n=16, 28.1%)	Active SpA (n=41, 71.9%)	P-value
Age, years	54.3±14.2	54.7±14.5	54.2±14.3	0.91
Female sex, n (%)	37 (64.9)	6 (37.5)	30 (73.2)	0.016
Duration of the disease, years	5.3±7.3	7.0±11.9	4.7±4.5	0.31
Disease presentation, n (%)
Peripheral	31 (54.4)	10 (62.5)	21 (51.2)	0.56
Entheseal	17 (29.8)	3 (18.7)	14 (34.1)	0.34
Dactylitis	14 (24.6)	4 (25.0)	10 (24.4)	0.96
Other inflammatory features, n (%)
Psoriasis	27 (47.4)	10 (62.5)	17 (42.5)	0.19
Crohn’s disease	9 (15.8)	2 (12.5)	7 (17.1)	0.97
Ulcerative colitis	4 (7.0)	1 (6.3)	3 (7.3)	0.89
Uveitis	2 (3.5)	0	2 (4.9)	0.96
Previous treatment, n (%)
DMARDs	42 (73.7)	7 (43.7)	35 (85.4)	0.004
Sulfasalazine	18 (31.6)	3 (18.7)	15 (36.6)
Methotrexate	11 (19.3)	3 (18.7)	8 (19.5)
Leflunomide	7 (12.3)	1 (6.3)	6 (14.6)
Anti-TNF-α monotherapy	3 (5.3)	0	3 (7.3)
Anti-TNF-α + methotrexate	1 (1.7)	0	1 (2.4)
Anti-TNF-α + sulfasalazine	1 (1.7)	0	1 (2.4)
BASDAI score (0–10)	5.7±2.4	2.8±0.7	6.9±1.8	<0.0001
BASMI score (0–10)	1.5±1.9	1.6±2.5	1.5±1.6	0.81

Notes: All values are expressed as mean ± SD or n (%). The sum of percentages may not be equal to 100 due to rounding.

Abbreviations: BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; DMARDs, disease-modifying antirheumatic drugs; SD, standard deviation; SpA, spondyloarthritis.

Figure 1 Patient disposition.

Abbreviations: GCs, glucocorticoids; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index.

Figure 2 Axial pain (A), peripheral pain (B), fatigue (C), and morning stiffness (D) at baseline (T0) and different time points on low-dose MR prednisone in patients with active or low-active spondyloarthritis.

Notes: The significant differences within treatment groups at weeks 4 and 12 are reported. No other comparisons were significant.
Abbreviations: T0, baseline evaluation; MR, modified-release; NRS, numerical rating scale.

Table 2 Absolute changes in important clinical and laboratory variables in patients with active SpA after 12 weeks of treatment with low-dose MR prednisone

Variables	Responders (n=22)	Nonresponders (n=19)	Difference
BASDAI score (0–10)
Baseline	6.5±1.7	7.3±1.9	0.18
Absolute change**	5.0±1.9	0.9±1.6	<0.0001
BASMI score (0–10)
Baseline	1.4±1.9	1.6±1.3	0.74
Absolute change	0.60±2.1	0.10±1.9	0.44
MASES (0–13)
Baseline	2.5±4.1	5.6±5.0	0.03
Absolute change	2.1±4.2	1.0±5.1	0.50
Axial pain (0–10)
Baseline	5.5±4.1	8.1±1.9	0.02
Absolute change**	4.4±4.5	0.8±1.5	0.02
Peripheral pain (0–10)
Baseline	6.4±3.6	8.8±1.7	0.01
Absolute change**	4.3±4.4	1.1±2.4	0.006
Sacroiliac pain (0–10)
Baseline	0.68±0.89	1.4±0.84	0.001
Absolute change	0.14±0.94	0.16±1.4	0.95
Fatigue (0–10)
Baseline	7.4±3.0	8.3±2.5	0.29
Absolute change**	5.0±3.7	1.3±2.4	0.0007
Morning stiffness severity (0–10)
Baseline	7.9±2.4	7.8±2.7	0.97
Absolute change**	6.1±2.6	1.3±2.7	<0.0001
Morning stiffness duration (min)
Baseline	71±42	58±44	0.36
Absolute change*	65±38	25±33	0.001
ESR (mm)
Baseline	22.8±19.6	19.0±15.3	0.51
Absolute change	4.9±9.3	3.8±7.4	0.67
CRP (mg/L)
Baseline	0.96±1.3	1.4±4.0	0.64
Absolute change	0.6±1.2	1.0±4.1	0.61

Notes: All values are expressed as mean ± SD.

* Interaction at week 12 between the subgroups, P<0.01.

** Interaction at week 12 between the subgroups, P<0.0001.

Abbreviations: BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MR, modified-release; SD, standard deviation; SpA, spondyloarthritis.