Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab DOI Creative Commons
Xing‐Hua Gao,

Weili Pan,

Min Zheng

et al.

Advances in Therapy, Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 13, 2024

In China, approximately 2.3 million people have psoriasis. Continuous treatment is recommended for moderate-to-severe This study aimed to evaluate the outcomes of continuous versus interrupted ixekizumab (IXE) and retreatment with IXE after disease worsening in Chinese patients. this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, patients were randomized or placebo at Week 0. At 12, responders (static Physician's Global Assessment [sPGA] score, 0 1 [0,1]) re-randomized (2:1) (IXE/IXE, treatment) (IXE/PBO, treatment). After re-randomization, IXE/PBO (relapse, sPGA ≥ 3) was switched every 4 weeks (IXE/PBO + IXEQ4W, retreatment). Efficacy assessed by evaluating response rates Psoriasis Area Severity Index (PASI) 75/90/100, (0,1), Dermatology Life Quality (DLQI) mean PASI, Itch Numerical Rating Scale (NRS) scores improvements special body areas. Safety evaluated assessing treatment-emergent adverse events (AEs) serious AEs. 289 IXE/IXE group (192 patients) (97 patients). High PASI 75 (0, 1) responses maintained until 60. 60, 88 (90.7%) had relapse; median time relapse 20 weeks. 24 retreatment, recaptured (97.2% 74.6%, respectively, IXEQ4W group). AEs comparable who received retreatment. treatment, high through 60 Most withdrawal. most these regained since 12. NCT03364309. a common skin condition that affects millions worldwide, including significant number China. effectiveness safety The focused on comparing where stopped taking medication then restarted it their symptoms worsened. found rates, meaning improved significantly stayed way However, returned discontinued medication; usually took occur. When within 12 weeks, concluded important maintaining control Additionally, if experience stopping medication, can effectively recapture improve again. profile consistent those previous studies, side effects being mild moderate severity. Overall, findings support using as long-term option managing psoriasis

Language: Английский

Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab DOI Creative Commons
Xing‐Hua Gao,

Weili Pan,

Min Zheng

et al.

Advances in Therapy, Journal Year: 2024, Volume and Issue: unknown

Published: Nov. 13, 2024

In China, approximately 2.3 million people have psoriasis. Continuous treatment is recommended for moderate-to-severe This study aimed to evaluate the outcomes of continuous versus interrupted ixekizumab (IXE) and retreatment with IXE after disease worsening in Chinese patients. this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, patients were randomized or placebo at Week 0. At 12, responders (static Physician's Global Assessment [sPGA] score, 0 1 [0,1]) re-randomized (2:1) (IXE/IXE, treatment) (IXE/PBO, treatment). After re-randomization, IXE/PBO (relapse, sPGA ≥ 3) was switched every 4 weeks (IXE/PBO + IXEQ4W, retreatment). Efficacy assessed by evaluating response rates Psoriasis Area Severity Index (PASI) 75/90/100, (0,1), Dermatology Life Quality (DLQI) mean PASI, Itch Numerical Rating Scale (NRS) scores improvements special body areas. Safety evaluated assessing treatment-emergent adverse events (AEs) serious AEs. 289 IXE/IXE group (192 patients) (97 patients). High PASI 75 (0, 1) responses maintained until 60. 60, 88 (90.7%) had relapse; median time relapse 20 weeks. 24 retreatment, recaptured (97.2% 74.6%, respectively, IXEQ4W group). AEs comparable who received retreatment. treatment, high through 60 Most withdrawal. most these regained since 12. NCT03364309. a common skin condition that affects millions worldwide, including significant number China. effectiveness safety The focused on comparing where stopped taking medication then restarted it their symptoms worsened. found rates, meaning improved significantly stayed way However, returned discontinued medication; usually took occur. When within 12 weeks, concluded important maintaining control Additionally, if experience stopping medication, can effectively recapture improve again. profile consistent those previous studies, side effects being mild moderate severity. Overall, findings support using as long-term option managing psoriasis

Language: Английский

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