PubMed:27716172 JSONTXT

{"project":"Zierdiyeerkenaili_800","denotations":[{"id":"T1","span":{"begin":13,"end":29},"obj":"DP"},{"id":"T2","span":{"begin":158,"end":167},"obj":"DP"},{"id":"T3","span":{"begin":2262,"end":2278},"obj":"DP"},{"id":"T4","span":{"begin":663,"end":679},"obj":"DP"},{"id":"T5","span":{"begin":955,"end":964},"obj":"DP"},{"id":"T6","span":{"begin":341,"end":352},"obj":"CI"},{"id":"T7","span":{"begin":90,"end":101},"obj":"CI"},{"id":"T8","span":{"begin":557,"end":568},"obj":"CI"},{"id":"T9","span":{"begin":1414,"end":1425},"obj":"CI"},{"id":"T10","span":{"begin":1521,"end":1532},"obj":"CI"},{"id":"T11","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T12","span":{"begin":1791,"end":1802},"obj":"CI"},{"id":"T13","span":{"begin":1840,"end":1851},"obj":"CI"},{"id":"T14","span":{"begin":1931,"end":1942},"obj":"CI"},{"id":"T15","span":{"begin":1973,"end":1984},"obj":"CI"},{"id":"T16","span":{"begin":2284,"end":2295},"obj":"CI"}],"text":"Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial.\nBACKGROUND: Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical agents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small molecule Janus kinase inhibitor investigated for the topical treatment of psoriasis.\nMETHODS: This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of tofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque psoriasis. Primary endpoint: proportion of patients with Calculated Physician's Global Assessment (PGA-C) clear or almost clear and ≥2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of patients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75) response; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item (ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured.\nRESULTS: Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients with PGA-C clear or almost clear and ≥2 grade improvement from baseline at Week 8 was 18.6 % for 2 % tofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib BID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference vs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 % tofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus was significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting Day 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced serious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group.\nCONCLUSIONS: In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.\nTRIAL REGISTRATION: NCT01831466 registered March 28, 2013."}

{"project":"wangzhuo19_800_2","denotations":[{"id":"T1","span":{"begin":90,"end":101},"obj":"CI"},{"id":"T2","span":{"begin":341,"end":352},"obj":"CI"},{"id":"T3","span":{"begin":557,"end":568},"obj":"CI"},{"id":"T4","span":{"begin":1414,"end":1425},"obj":"CI"},{"id":"T5","span":{"begin":1521,"end":1532},"obj":"CI"},{"id":"T6","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T7","span":{"begin":1931,"end":1942},"obj":"CI"},{"id":"T8","span":{"begin":1791,"end":1802},"obj":"CI"},{"id":"T9","span":{"begin":1973,"end":1984},"obj":"CI"},{"id":"T10","span":{"begin":663,"end":679},"obj":"DP"},{"id":"T11","span":{"begin":13,"end":29},"obj":"DP"},{"id":"T12","span":{"begin":2262,"end":2278},"obj":"DP"}],"text":"Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial.\nBACKGROUND: Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical agents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small molecule Janus kinase inhibitor investigated for the topical treatment of psoriasis.\nMETHODS: This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of tofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque psoriasis. Primary endpoint: proportion of patients with Calculated Physician's Global Assessment (PGA-C) clear or almost clear and ≥2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of patients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75) response; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item (ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured.\nRESULTS: Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients with PGA-C clear or almost clear and ≥2 grade improvement from baseline at Week 8 was 18.6 % for 2 % tofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib BID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference vs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 % tofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus was significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting Day 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced serious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group.\nCONCLUSIONS: In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.\nTRIAL REGISTRATION: NCT01831466 registered March 28, 2013."}

{"project":"Zierdiyeerkenaili_800_2","denotations":[{"id":"T2","span":{"begin":158,"end":167},"obj":"DP"},{"id":"T3","span":{"begin":438,"end":447},"obj":"DP"},{"id":"T6","span":{"begin":13,"end":29},"obj":"DP"},{"id":"T7","span":{"begin":663,"end":679},"obj":"DP"},{"id":"T8","span":{"begin":2262,"end":2278},"obj":"DP"},{"id":"T9","span":{"begin":90,"end":101},"obj":"CI"},{"id":"T10","span":{"begin":557,"end":568},"obj":"CI"},{"id":"T11","span":{"begin":1414,"end":1425},"obj":"CI"},{"id":"T12","span":{"begin":1521,"end":1532},"obj":"CI"},{"id":"T13","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T14","span":{"begin":1791,"end":1802},"obj":"CI"},{"id":"T15","span":{"begin":1840,"end":1851},"obj":"CI"},{"id":"T16","span":{"begin":1931,"end":1942},"obj":"CI"},{"id":"T17","span":{"begin":1973,"end":1984},"obj":"CI"},{"id":"T18","span":{"begin":2284,"end":2295},"obj":"CI"},{"id":"T19","span":{"begin":341,"end":352},"obj":"CI"}],"text":"Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial.\nBACKGROUND: Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical agents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small molecule Janus kinase inhibitor investigated for the topical treatment of psoriasis.\nMETHODS: This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of tofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque psoriasis. Primary endpoint: proportion of patients with Calculated Physician's Global Assessment (PGA-C) clear or almost clear and ≥2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of patients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75) response; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item (ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured.\nRESULTS: Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients with PGA-C clear or almost clear and ≥2 grade improvement from baseline at Week 8 was 18.6 % for 2 % tofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib BID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference vs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 % tofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus was significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting Day 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced serious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group.\nCONCLUSIONS: In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.\nTRIAL REGISTRATION: NCT01831466 registered March 28, 2013."}

{"project":"chenxin_473849_800_3","denotations":[{"id":"T1","span":{"begin":20,"end":29},"obj":"DP"},{"id":"T10","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T11","span":{"begin":1791,"end":1802},"obj":"CI"},{"id":"T12","span":{"begin":1840,"end":1851},"obj":"CI"},{"id":"T13","span":{"begin":1931,"end":1942},"obj":"CI"},{"id":"T14","span":{"begin":1973,"end":1984},"obj":"CI"},{"id":"T15","span":{"begin":2284,"end":2295},"obj":"CI"},{"id":"T2","span":{"begin":158,"end":167},"obj":"DP"},{"id":"T3","span":{"begin":438,"end":447},"obj":"DP"},{"id":"T4","span":{"begin":670,"end":679},"obj":"DP"},{"id":"T5","span":{"begin":2269,"end":2278},"obj":"DP"},{"id":"T6","span":{"begin":90,"end":101},"obj":"CI"},{"id":"T7","span":{"begin":557,"end":568},"obj":"CI"},{"id":"T8","span":{"begin":1414,"end":1425},"obj":"CI"},{"id":"T9","span":{"begin":1521,"end":1532},"obj":"CI"},{"id":"T16","span":{"begin":341,"end":352},"obj":"CI"}],"text":"Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial.\nBACKGROUND: Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical agents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small molecule Janus kinase inhibitor investigated for the topical treatment of psoriasis.\nMETHODS: This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of tofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque psoriasis. Primary endpoint: proportion of patients with Calculated Physician's Global Assessment (PGA-C) clear or almost clear and ≥2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of patients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75) response; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item (ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured.\nRESULTS: Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients with PGA-C clear or almost clear and ≥2 grade improvement from baseline at Week 8 was 18.6 % for 2 % tofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib BID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference vs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 % tofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus was significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting Day 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced serious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group.\nCONCLUSIONS: In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.\nTRIAL REGISTRATION: NCT01831466 registered March 28, 2013."}

{"project":"yangbin123xm_800_3","denotations":[{"id":"T10","span":{"begin":557,"end":568},"obj":"CI"},{"id":"T11","span":{"begin":1414,"end":1425},"obj":"CI"},{"id":"T12","span":{"begin":1521,"end":1532},"obj":"CI"},{"id":"T13","span":{"begin":1760,"end":1771},"obj":"CI"},{"id":"T14","span":{"begin":1791,"end":1802},"obj":"CI"},{"id":"T15","span":{"begin":1840,"end":1851},"obj":"CI"},{"id":"T16","span":{"begin":1931,"end":1942},"obj":"CI"},{"id":"T17","span":{"begin":1973,"end":1984},"obj":"CI"},{"id":"T2","span":{"begin":20,"end":29},"obj":"DP"},{"id":"T3","span":{"begin":90,"end":101},"obj":"CI"},{"id":"T4","span":{"begin":158,"end":167},"obj":"DP"},{"id":"T5","span":{"begin":438,"end":447},"obj":"DP"},{"id":"T6","span":{"begin":670,"end":679},"obj":"DP"},{"id":"T8","span":{"begin":2269,"end":2278},"obj":"DP"},{"id":"T9","span":{"begin":341,"end":352},"obj":"CI"},{"id":"T18","span":{"begin":2284,"end":2295},"obj":"CI"}],"text":"Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial.\nBACKGROUND: Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical agents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small molecule Janus kinase inhibitor investigated for the topical treatment of psoriasis.\nMETHODS: This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of tofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque psoriasis. Primary endpoint: proportion of patients with Calculated Physician's Global Assessment (PGA-C) clear or almost clear and ≥2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of patients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75) response; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item (ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured.\nRESULTS: Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients with PGA-C clear or almost clear and ≥2 grade improvement from baseline at Week 8 was 18.6 % for 2 % tofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib BID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference vs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 % tofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus was significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting Day 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced serious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group.\nCONCLUSIONS: In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile.\nTRIAL REGISTRATION: NCT01831466 registered March 28, 2013."}