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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.

Tsuboi H, Matsumoto I, Hagiwara S, Hirota T, Takahashi H, Ebe H, Yokosawa M, Hagiya C, Asashima H, Takai C, Miki H, Umeda N, Kondo Y, Ogishima H, Suzuki T, Hirata S, Saito K, Tanaka Y, Horai Y, Nakamura H, Kawakami A, Sumida T - Mod Rheumatol (2014)

Bottom Line: Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections.Conclusion.Abatacept seems to be effective for both RA and RA-related secondary SS.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Faculty of Medicine, University of Tsukuba , Tsukuba, Ibaraki Prefecture , Japan.

ABSTRACT
Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion. Abatacept seems to be effective for both RA and RA-related secondary SS.

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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.
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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.

Mentions: Abatacept significantly decreased patients' VAS for dry mouth and dry eye from 53.3 ± 25.4 and 39.9 ± 28.6 mm at 0 week to 41.0 ± 30.8 and 30.8 ± 24.4 mm at 24 weeks (P < 0.05), respectively (Figure 3A). However, abatacept did not change patients' VAS for parotid pain (Figure 3A). Abatacept significantly decreased physicians' VAS for keratoconjunctivitis sicca (KCS) and general condition from 44.7 ± 28.0 and 35.9 ± 19.3 mm at 0 week to 32.5 ± 23.8 and 25.8 ± 21.6 mm at 24 weeks (P < 0.05), respectively (Figure 3B).


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.

Tsuboi H, Matsumoto I, Hagiwara S, Hirota T, Takahashi H, Ebe H, Yokosawa M, Hagiya C, Asashima H, Takai C, Miki H, Umeda N, Kondo Y, Ogishima H, Suzuki T, Hirata S, Saito K, Tanaka Y, Horai Y, Nakamura H, Kawakami A, Sumida T - Mod Rheumatol (2014)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4389760&req=5

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.
Mentions: Abatacept significantly decreased patients' VAS for dry mouth and dry eye from 53.3 ± 25.4 and 39.9 ± 28.6 mm at 0 week to 41.0 ± 30.8 and 30.8 ± 24.4 mm at 24 weeks (P < 0.05), respectively (Figure 3A). However, abatacept did not change patients' VAS for parotid pain (Figure 3A). Abatacept significantly decreased physicians' VAS for keratoconjunctivitis sicca (KCS) and general condition from 44.7 ± 28.0 and 35.9 ± 19.3 mm at 0 week to 32.5 ± 23.8 and 25.8 ± 21.6 mm at 24 weeks (P < 0.05), respectively (Figure 3B).

Bottom Line: Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections.Conclusion.Abatacept seems to be effective for both RA and RA-related secondary SS.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Faculty of Medicine, University of Tsukuba , Tsukuba, Ibaraki Prefecture , Japan.

ABSTRACT
Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion. Abatacept seems to be effective for both RA and RA-related secondary SS.

Show MeSH
Related in: MedlinePlus