Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis(RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and l...Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis(RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and long?term extension(LTE) studies.Methods: ORAL Sync was a 1?year, randomized, placebo?controlled, Phase 3 trial. Patients received tofacitinib 5 or 10 mg twice daily(BID) or placebo advanced to tofacitinib 5 or 10 mg BID at 3 or 6 months. All patients remained on ≥1 background conventional synthetic disease?modifying antirheumatic drug. ORAL Sequel is an open?label LTE study(data?cut: March 2015; data collection and analyses were ongoing, and study database was not locked at the time of analysis; study was closed in 2017). Efficacy outcomes: American College of Rheumatology(ACR) 20/50/70 response rates and Disease Activity Score in 28 joints using erythrocyte sedimentation rate(DAS28?4 [ESR]). Patient? and physician?reported outcomes: Health Assessment Questionnaire?Disability Index(HAQ?DI), Patient and Physician Global Assessment of Arthritis, and pain(visual analog scale). Safety was assessed throughout.Results: ORAL Sync included 218 patients; 192 were subsequently enrolled into ORAL Sequel. In ORAL Sync, more patients achieved ACR20(tofacitinib 5 mg BID, 67.4%; 10 mg BID, 70.6%; placebo, 34.1%) and DAS28?4(ESR) <2.6(tofacitinib 5 mg BID, 7.1%;10 mg BID, 13.1%; placebo, 2.3%) with tofacitinib versus placebo at Month 6. Mean changes from baseline in HAQ?DI were greater with tofacitinib versus placebo at Month 6. In ORAL Sequel, efficacy was consistent to Month 48. Incidence rates for adverse events of special interest in tofacitinib?treated patients were similar to the global population.Conclusions: Tofacitinib significantly reduced signs/symptoms and improved physical function and quality of life in Chinese patients with moderate?to?severely active RA up to Month 48. The safety profile was consistent with the global population.Clinical Trial Identifier: NCT00856544 and NCT00413699.展开更多
Background： Approximately 15-20% cases of systemic lupus erythematosus （SLE） are diagnosed in children. There have been a Few studies reporting the epidemiological data of pediatric-onset SLE （cSLE） in China, nei...Background： Approximately 15-20% cases of systemic lupus erythematosus （SLE） are diagnosed in children. There have been a Few studies reporting the epidemiological data of pediatric-onset SLE （cSLE） in China, neither comparing the differences between cSLE and adult-onset SLE （aSLE）. The aim of this study was to describe the impact of age of onset on clinical features and survival in cSLE patients in China based on the Chinese SLE Treatment and Research group （CSTAR） database. Methods： We made a prospective study of 225 cSLE patients （aged 〈16 years） and 1759 patients aged 16-50 years based on CSTAR registry. We analyzed initial symptoms, clinical presentations, SLE disease activity, damages, and outcomes ofcSLE, as well as compared with aSLE patients. Results： The mean age ofcSLE patients was 12.16 ± 2.92 years, with 187 （83.1%） females. Fever （P 〈 0.001） as well as mucocutaneous （P 〈 0.001 ） and renal （P = 0.006） disorders were found to be significantly more frequent in cSLE patients as initial symptoms, while muscle and joint lesions were significantly less common compared to aSLE subjects （P 〈 0.001 ）. The eSLE patients were found to present more fi＇equently with malar rash （P = 0.001; odds ratio {OR], 0.624; 95% confidence interval [CI ], 0.470 0.829） but less tYequently with arthritis （P 〈 0.001 ; OR, 2.013; 95% CI, 1.512-2.679） and serositis （P = 0.030; OR, 1.629; 95% CI, 1.053 2.520）. There was no significant difl＇erence in SLE disease activity index scores between cSLE and aSLE groups （P = 0.478）. Cox regression indicated that childhood onset was the risk factor for organ damage in lupus patients （hazard ratio 0.335 [0.170 0.658], P = 0.001）. The survival curves between the cSLE and aSLE groups had no significant difference as determined by the log-rank test （0.557, P = 0.455）. Conclusions： cSLE in China has different clinical features and more inflammation than aSLE patients. Damage may be less in children and there is no difl＇erence in 5- year survival between cSLE and aSLE groups.展开更多
文摘Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis(RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and long?term extension(LTE) studies.Methods: ORAL Sync was a 1?year, randomized, placebo?controlled, Phase 3 trial. Patients received tofacitinib 5 or 10 mg twice daily(BID) or placebo advanced to tofacitinib 5 or 10 mg BID at 3 or 6 months. All patients remained on ≥1 background conventional synthetic disease?modifying antirheumatic drug. ORAL Sequel is an open?label LTE study(data?cut: March 2015; data collection and analyses were ongoing, and study database was not locked at the time of analysis; study was closed in 2017). Efficacy outcomes: American College of Rheumatology(ACR) 20/50/70 response rates and Disease Activity Score in 28 joints using erythrocyte sedimentation rate(DAS28?4 [ESR]). Patient? and physician?reported outcomes: Health Assessment Questionnaire?Disability Index(HAQ?DI), Patient and Physician Global Assessment of Arthritis, and pain(visual analog scale). Safety was assessed throughout.Results: ORAL Sync included 218 patients; 192 were subsequently enrolled into ORAL Sequel. In ORAL Sync, more patients achieved ACR20(tofacitinib 5 mg BID, 67.4%; 10 mg BID, 70.6%; placebo, 34.1%) and DAS28?4(ESR) <2.6(tofacitinib 5 mg BID, 7.1%;10 mg BID, 13.1%; placebo, 2.3%) with tofacitinib versus placebo at Month 6. Mean changes from baseline in HAQ?DI were greater with tofacitinib versus placebo at Month 6. In ORAL Sequel, efficacy was consistent to Month 48. Incidence rates for adverse events of special interest in tofacitinib?treated patients were similar to the global population.Conclusions: Tofacitinib significantly reduced signs/symptoms and improved physical function and quality of life in Chinese patients with moderate?to?severely active RA up to Month 48. The safety profile was consistent with the global population.Clinical Trial Identifier: NCT00856544 and NCT00413699.
文摘Background： Approximately 15-20% cases of systemic lupus erythematosus （SLE） are diagnosed in children. There have been a Few studies reporting the epidemiological data of pediatric-onset SLE （cSLE） in China, neither comparing the differences between cSLE and adult-onset SLE （aSLE）. The aim of this study was to describe the impact of age of onset on clinical features and survival in cSLE patients in China based on the Chinese SLE Treatment and Research group （CSTAR） database. Methods： We made a prospective study of 225 cSLE patients （aged 〈16 years） and 1759 patients aged 16-50 years based on CSTAR registry. We analyzed initial symptoms, clinical presentations, SLE disease activity, damages, and outcomes ofcSLE, as well as compared with aSLE patients. Results： The mean age ofcSLE patients was 12.16 ± 2.92 years, with 187 （83.1%） females. Fever （P 〈 0.001） as well as mucocutaneous （P 〈 0.001 ） and renal （P = 0.006） disorders were found to be significantly more frequent in cSLE patients as initial symptoms, while muscle and joint lesions were significantly less common compared to aSLE subjects （P 〈 0.001 ）. The eSLE patients were found to present more fi＇equently with malar rash （P = 0.001; odds ratio {OR], 0.624; 95% confidence interval [CI ], 0.470 0.829） but less tYequently with arthritis （P 〈 0.001 ; OR, 2.013; 95% CI, 1.512-2.679） and serositis （P = 0.030; OR, 1.629; 95% CI, 1.053 2.520）. There was no significant difl＇erence in SLE disease activity index scores between cSLE and aSLE groups （P = 0.478）. Cox regression indicated that childhood onset was the risk factor for organ damage in lupus patients （hazard ratio 0.335 [0.170 0.658], P = 0.001）. The survival curves between the cSLE and aSLE groups had no significant difference as determined by the log-rank test （0.557, P = 0.455）. Conclusions： cSLE in China has different clinical features and more inflammation than aSLE patients. Damage may be less in children and there is no difl＇erence in 5- year survival between cSLE and aSLE groups.
