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Modern Rheumatology Volume 25, 2015 - Issue 2
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Original Article

Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: Rheumatoid Arthritis with Orencia Trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial—an open-label, one-year, prospective study—Interim analysis of 32 patients for 24 weeks

Hiroto TsuboiDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Isao MatsumotoDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Shinya HagiwaraDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Tomoya HirotaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Hiroyuki TakahashiDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Hiroshi EbeDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Masahiro YokosawaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Chihiro HagiyaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Hiromitsu AsashimaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Chinatsu TakaiDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Haruka MikiDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Naoto UmedaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Yuya KondoDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Hiroshi OgishimaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Takeshi SuzukiDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, Japan
,
Shintaro HirataThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Fukuoka Prefecture, Japan
,
Kazuyoshi SaitoThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Fukuoka Prefecture, Japan
,
Yoshiya TanakaThe First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu City, Fukuoka Prefecture, Japan
,
Yoshiro HoraiUnit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
,
Hideki NakamuraUnit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
,
Atsushi KawakamiUnit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
&
Takayuki SumidaDepartment of Internal Medicine, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki Prefecture, JapanCorrespondence[email protected]
 show all
Pages 187-193 | Received 10 Jul 2014, Accepted 30 Jul 2014, Published online: 11 Sep 2014

Figures & data

Table 1. Clinicopathological features of enrolled patients at baseline (N = 32).

Figure 1. Effect of abatacept on RA. (A) Effects of abatacept treatment on Simplified Disease Activity Index (SDAI) in 31 patients. Data deficit was compensated by the last observation carried forward (LOCF) method (*P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept. (B) Effects of abatacept treatment on SDAI in 7 bio-switch patients and 24 bio-naïve patients. Data deficit compensated by the LOCF method (*P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. The difference between two groups was examined using Mann–Whitney U-test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept and methotrexate combination treatment on SDAI in 23 patients and of abatacept alone in 8 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant.

Figure 1. Effect of abatacept on RA. (A) Effects of abatacept treatment on Simplified Disease Activity Index (SDAI) in 31 patients. Data deficit was compensated by the last observation carried forward (LOCF) method (*P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept. (B) Effects of abatacept treatment on SDAI in 7 bio-switch patients and 24 bio-naïve patients. Data deficit compensated by the LOCF method (*P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. The difference between two groups was examined using Mann–Whitney U-test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept and methotrexate combination treatment on SDAI in 23 patients and of abatacept alone in 8 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant.

Figure 2. Effect of abatacept treatment on RA disease activity. Effects of abatacept treatment on disease activity as assessed by SADI in 31 patients. Data deficit was compensated by the LOCF method. ABT, abatacept.

Figure 2. Effect of abatacept treatment on RA disease activity. Effects of abatacept treatment on disease activity as assessed by SADI in 31 patients. Data deficit was compensated by the LOCF method. ABT, abatacept.

Figure 3. Effect of abatacept on VAS in SS. (A) Effects of abatacept treatment on patients’ VAS for dry mouth, dry eye, and parotid pain in 29 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. VAS, visual analog scale; N.S, not significant. (B) Effects of abatacept treatment on physicians’ VAS for dry mouth, keratoconjunctivitis sicca, and general condition in 28 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. VAS, visual analog scale; KCS, keratoconjunctivitis sicca.

Figure 3. Effect of abatacept on VAS in SS. (A) Effects of abatacept treatment on patients’ VAS for dry mouth, dry eye, and parotid pain in 29 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. VAS, visual analog scale; N.S, not significant. (B) Effects of abatacept treatment on physicians’ VAS for dry mouth, keratoconjunctivitis sicca, and general condition in 28 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. VAS, visual analog scale; KCS, keratoconjunctivitis sicca.

Figure 4. Effects of abatacept on secretory function in SS. (A) Effects of abatacept treatment on saliva volume assessed by Saxson's test in 29 patients. Data deficit was compensated by the LOCF method. N.S, not significant vs. 0 week (baseline); Wilcoxon signed-rank test; ABT, abatacept. (B) Effect of abatacept treatment on saliva volume assessed by Saxson's test in 11 patients with Greenspan grading 1/2 of labial salivary gland (LSG) biopsy and in 16 patients with grade 3/4. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept treatment on tear volume assessed by Schirmer's test in 25 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept.

Figure 4. Effects of abatacept on secretory function in SS. (A) Effects of abatacept treatment on saliva volume assessed by Saxson's test in 29 patients. Data deficit was compensated by the LOCF method. N.S, not significant vs. 0 week (baseline); Wilcoxon signed-rank test; ABT, abatacept. (B) Effect of abatacept treatment on saliva volume assessed by Saxson's test in 11 patients with Greenspan grading 1/2 of labial salivary gland (LSG) biopsy and in 16 patients with grade 3/4. Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), Wilcoxon signed-rank test. Difference between two groups was examined using Mann–Whitney U test. ABT, abatacept; N.S, not significant. (C) Effects of abatacept treatment on tear volume assessed by Schirmer's test in 25 patients. Data deficit was compensated by the LOCF method (*P < 0.05 vs. 0 week [baseline]), Wilcoxon signed-rank test. ABT, abatacept.

Figure 5. Effect of abatacept on IgG, RF, and anti-SS-A antibody in SS. Effects of abatacept treatment on (A) serum IgG level (n = 31), (B) serum RF level (n = 30 patients), (C) titer of anti-SS-A antibody (n = 20 patients). Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), N.S; not significant vs baseline, Wilcoxon signed-rank test. ABT; abatacept.

Figure 5. Effect of abatacept on IgG, RF, and anti-SS-A antibody in SS. Effects of abatacept treatment on (A) serum IgG level (n = 31), (B) serum RF level (n = 30 patients), (C) titer of anti-SS-A antibody (n = 20 patients). Data deficit was compensated by the LOCF method (*P < 0.05 vs 0 week [baseline]), N.S; not significant vs baseline, Wilcoxon signed-rank test. ABT; abatacept.

Figure 6. Correlation between improvement in SS and RA. Correlation between (A) increase in saliva volume (assessed by Saxon's test) and fall in SDAI (n = 29 patients). Spearman's rank correlation coefficient = 0.211, not significant, and (B) between increase of tear volume (assessed by Schirmer's test) and fall in SDAI (n = 25 patients). Data deficit was compensated by the LOCF method. Spearman's rank correlation coefficient = 0.333, not significant.

Figure 6. Correlation between improvement in SS and RA. Correlation between (A) increase in saliva volume (assessed by Saxon's test) and fall in SDAI (n = 29 patients). Spearman's rank correlation coefficient = 0.211, not significant, and (B) between increase of tear volume (assessed by Schirmer's test) and fall in SDAI (n = 25 patients). Data deficit was compensated by the LOCF method. Spearman's rank correlation coefficient = 0.333, not significant.

Table 2. Adverse events in 32 cases during 24 weeks.

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