Limits...
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.

Show MeSH

Related in: MedlinePlus

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

License
getmorefigures.php?uid=PMC4389760&req=5

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.

Mentions: Saliva volume by Saxson's test increased slightly from 2232 ± 1908 mg/2 min at 0 week to 2424 ± 2004 mg/2 min at 24 weeks in 29 patients (Figure 4A). Interestingly, in 11 patients with Greenspan grading 1/2 of LSG biopsy, saliva volume significantly increased from 2945 ± 2090 mg/2 min at 0 week to 3419 ± 2121 mg/2 min at 24 weeks (P < 0.05; Figure 4B). Tear volume by Schirmer's test significantly increased from 3.6 ± 4.6 mm/5 min at 0 week to 5.5 ± 7.1 mm/5 min at 24 weeks in 25 patients (P < 0.05; Figure 4C).


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)

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

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

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.
Mentions: Saliva volume by Saxson's test increased slightly from 2232 ± 1908 mg/2 min at 0 week to 2424 ± 2004 mg/2 min at 24 weeks in 29 patients (Figure 4A). Interestingly, in 11 patients with Greenspan grading 1/2 of LSG biopsy, saliva volume significantly increased from 2945 ± 2090 mg/2 min at 0 week to 3419 ± 2121 mg/2 min at 24 weeks (P < 0.05; Figure 4B). Tear volume by Schirmer's test significantly increased from 3.6 ± 4.6 mm/5 min at 0 week to 5.5 ± 7.1 mm/5 min at 24 weeks in 25 patients (P < 0.05; Figure 4C).

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