Azilsartan improves the effects of etanercept in patients with active rheumatoid arthritis: a pilot study

Figures & data

Figure 1 Flow chart of the study.

Abbreviations: Azil, azilsartan; Etan, etanercept; RA, rheumatoid arthritis.

Figure 2 Effect of Azil on the ESR of patients with active RA maintained on Etan.

Notes: *Significantly different from baseline in each group (paired t-test, P<0.05). Values with non-identical superscripts (a, b) among groups were significantly different (ANOVA, P<0.05).
Abbreviations: ANOVA, analysis of variance; Azil, azilsartan; ESR, erythrocyte sedimentation rate; Etan, etanercept; RA, rheumatoid arthritis.

Figure 3 Effect of Azil on serum CRP of patients with active RA maintained on Etan.

Notes: Values with non-identical superscripts (a, b) among groups were significantly different (ANOVA, P<0.05). *Significantly different from baseline in each group (paired t-test, P<0.05).
Abbreviations: Azil, azilsartan; CRP, C-reactive protein level; Etan, etanercept; RA, rheumatoid arthritis.

Table 1 Demographic data and baseline characteristics of the RA patients treated with Etan or its combination with Azil

Parameters	Etan + placebo N=16	Etan + Azil N=20	P-value
Gender, n (%)
Male	4 (25)	6 (30)	0.4
Female	12 (75)	14 (70)	0.32
Age (years)	47.9±11.7	45.7±10.4	0.56
Body weight (kg)	88.5±17.5	86.8±15.6	0.18
BMI (kg/m^2)	32.1±2.7	33.1±3.0	0.38
Disease duration (year)	7.2±2.6	8.5±2.4	0.12
MTX treatment (months)	35.3±7.0	34.6±5.8	0.76
ESR (mm/h)	49.8±14.3	48.5±15.8	0.49
CRP (μg/mL)	9.8±5.5	12.0±4.5	0.38
DAS-28 score (four values)	6.0±0.57	6.4±0.82	0.12
SDAI score	26.4±3.9	27.2±4.9	0.59
HAQ-DI score	1.9±0.30	2.04±0.37	0.28
CDAI score	30.4±6.4	30.2±4.9	0.94
Joint deformities, n (%)	5 (31.4)	7 (35.0)	0.40
Use of steroids (<10 mg/day prednisolone), n (%)	4 (25)	5 (22.7)	0.62
Use of NSAIDs, n (%)	7 (43.8)	10 (45.5)	0.58
Associated diseases, n (%)
Hypertension, n (%)	15 (93.8)	17 (85.0)	0.19
Diabetes mellitus, n (%)	2 (12.5)	3 (15.0)	0.32
Smoking habits, n (%)	1 (6.2)	2 (10.0)	0.14

Note: Data shown as mean ± SD unless indicated otherwise.

Abbreviations: Azil, azilsartan; CDAI, clinical disease activity index; CRP, C-reactive protein; DAS-28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; Etan, etanercept; HAQ-DI, health assessment questionnaire disease index; MTX, methotrexate; RA, rheumatoid arthritis; SDAI, simplified disease activity index.

Table 2 Effect of Azil on DAS-28, SDAI, HAQ-DI, and CDAI of patients with active RA maintained on Etan

Clinical score	Etan + placebo (N=16)		Etan + Azil (N=20)
	Zero time	After 90 days	Zero time	After 90 days
DAS-28	6.01±0.57^a	4.9±0.5^b,*	6.4±0.82^a	4.4±0.23^c,*
SDAI	26.4±3.9^a	23.4±3.7^a	27.2±4.9^a	18.1±4.2^b,*
HAQ-DI-DI	1.9±0.3^a	1.6±0.2^b,*	2.0±0.4^a	1.3±0.3^c,*
CDAI	30.4±6.4^a	23.1±5.7^b,*	30.2±4.9^a	19.3±4.8^c,*

Notes: Data shown as mean ± SD.

* Significantly different from baseline in each group (paired t-test, P<0.05). Values with non-identical superscripts (a, b, c) among groups were significantly different (ANOVA, P<0.05).

Abbreviations: ANOVA, analysis of variance; Azil, azilsartan; CDAI, clinical disease activity index; CRP, C-reactive protein; DAS-28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; Etan, etanercept; HAQ-DI, health assessment questionnaire disease index; MTX, methotrexate; RA, rheumatoid arthritis; SDAI, simplified disease activity index.

Table 3 Effect of Azil on different functional areas of the DAS-28 score of patients with active RA maintained on Etan

Clinical score	Etan + placebo (N=16)		Etan + Azil (N=20)
	Zero time	After 90 days	Zero time	After 90 days
TJC	12.6±3.1^a	8.9±4.2^b,*	11.3±3.6^a	6.9±2.9^c,*
SJC	5.3±1.1^a	3.9±1.1^b,*	4.6±1.5^a	1.9±1.5^c,*
VAS-100 (mm)	65±9.8^a	55.6±10.9^b,*	68±12.8^a	51.3±6.5^b,*
EGA (cm)	6.6±0.81^a	5.3±0.87^b,*	6.7±0.92^a	4.2±0.81^c,*
Morning stiffness (min)	32.5±20.4^a	25.1±17.8^a	29.0±18.4^a	13.3±11.7^b,*

Notes: Data shown as mean ± SD.

* Significantly different from baseline in each group (paired t-test, P<0.05). Values with non-identical superscripts (a, b, c) among groups were significantly different (ANOVA, P<0.05).

Abbreviations: ANOVA, analysis of variance; Azil, azilsartan; DAS-28, 28-joint Disease Activity Score; EGA, evaluator global assessment; Etan, etanercept; RA, rheumatoid arthritis; SJC, swollen joint count; TJC, tender joint count; VAS, visual analog score.

Table 4 Effect of Azil on different functional areas of HAQ-DI score of patients with active RA maintained on Etan

Parameters	Etan + placebo (N=16)			Etan + Azil (N=20)
	Zero time	After 90 days	% change	Zero time	After 90 days	% change
Dress	1.6±0.8^a	0.8±0.7^b,*	50.3 ↓	1.6±0.6^a	0.7±0.6^b,*	58.1 ↓
Arise	1.5±0.7^a	1.1±0.5^b,*	41.5 ↓	1.7±0.8^a	0.8±0.6^b,*	55.8 ↓
Eat	1.8±0.8^a	1.3±0.8^b,*	30.9 ↓	2.1±0.7^a	0.7±0.5^c,*	66.6 ↓
Walk	1.9±0.8^a	1.4±0.7^b,*	19.1 ↓	2.2±0.9^a	0.9±0.6^c,*	59.1 ↓
Hygiene	1.6±0.9^a	1.1±0.9^b,*	34.9 ↓	1.9±0.7^a	0.7±0.7^b,*	65.8 ↓
Reach	2.1±0.9^a	1.9±1.1^a	11.9 ↓	2.6±0.7^a	1.2±0.6^b,*	53.8 ↓
Grip	1.6±0.6^a	1.2±0.8^a	24.4 ↓	1.8±0.7^a	0.7±0.6^b,*	60.0 ↓
Daily activity	2.0±0.9^a	1.5±1.0^b,*	25.0 ↓	2.6±0.8^a	1.2±0.7^b,*	47.1 ↓

Notes: Data shown as mean ± SD.

* Significantly different from baseline in each group (paired t-test, P<0.05). Values with non-identical superscripts (a, b, c) among groups were significantly different (ANOVA, P<0.05).

Abbreviations: ANOVA, analysis of variance; Azil, azilsartan; Etan, etanercept; HAQ-DI, health assessment questionnaire disability index; RA, rheumatoid arthritis.