Dataset Information

Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis.

ABSTRACT: Objective: The purpose of this study was to evaluate the speed of onset of clinical response to ixekizumab (IXE) and assess the progression of visible improvement in patients with moderate-to-severe plaque psoriasis. Design: This was an interventional, randomized, open-label, Phase IIIb clinical trial. Setting: This was a single center study at the Mount Sinai School of Medicine. Participants: Twelve patients were randomized at a ratio of 1:1 to receive 80mg of ixekizumab every two (IXE Q2W) or four (IXE Q4W) weeks following a starting dose of 160mg of ixekizumab. After Week 12, all patients received 80mg IXE Q4W through Week 44. Measurements: Clinical response was measured using the Patient's Global Assessment (PatGA), the Psoriasis Area and Severity Index (PASI), the static Physician's Global Assessment (sPGA), and the Itch Numeric Rating Scale (Itch NRS). Sequential patient photographs were taken at regular intervals during the study to evaluate visible improvement in plaque psoriasis. Results: The median time to an improvement of at least 1 point or 2 points from baseline in PatGA score was 5.0 and 10.0 days for patients randomized to IXE Q2W and 6.0 and 13.5 days for patients randomized to IXE Q4W. All patients achieved at least a 50- or 75-percent improvement in PASI from baseline by Weeks 2 and 4, respectively. At least half of the patients achieved at least a 4-point improvement from baseline in Itch NRS by Day 14. Improvement in disease was visibly evident within one week of treatment in patient photographs. Conclusion: Ixekizumab results in a rapid and visible improvement in plaque psoriasis in as early as one week of treatment.

SUBMITTER: Khattri S

PROVIDER: S-EPMC5955632 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis.

Khattri Saakshi S Goldblum Orin O Solotkin Kathleen K Amir Yasmin Y Min Michelle S MS Ridenour Terri T Yang Fan Emily FE Lebwohl Mark M

The Journal of clinical and aesthetic dermatology 20180501 5

Objective: The purpose of this study was to evaluate the speed of onset of clinical response to ixekizumab (IXE) and assess the progression of visible improvement in patients with moderate-to-severe plaque psoriasis. Design: This was an interventional, randomized, open-label, Phase IIIb clinical trial. Setting: This was a single center study at the Mount Sinai School of Medicine. Participants: Twelve patients were randomized at a ratio of 1:1 to receive 80mg of ixekiz ...[more]

PMID: 29785237

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Project description:IntroductionPsoriasis, an incurable chronic inflammatory disease, affects over 6 million people in China. Ixekizumab, a monoclonal antibody against interleukin-17A, has demonstrated efficacy and safety for the treatment of moderate-to-severe plaque psoriasis, although limited data are available regarding its use in routine clinical practice in China. We investigated the real-world application of ixekizumab in China.MethodsAdults (≥ 18 years) with moderate-to-severe plaque psoriasis prescribed ixekizumab in routine clinical practice were enrolled in this prospective, observational, single-arm, multicenter, post-marketing surveillance study. The primary endpoint was the safety of ixekizumab at week 12. The effectiveness of ixekizumab, based on the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), was assessed as a secondary endpoint.ResultsIn total, 666 patients were enrolled; 663 were included in the safety analysis, and 612 in the effectiveness analysis. At least one adverse event (AE) was reported by 42.7% (283/663) of patients, most of which were mild (242/283, 85.5%), and 32.7% (217/663) of patients reported AEs related to study treatment. The most frequently reported AEs were injection site reactions. AEs led to discontinuation in five patients (0.8%). Only three patients had a serious AE. Mean ± standard deviation (SD) change from baseline in PASI score was reduction in 10.79 ± 9.55 at week 2 and 16.80 ± 12.15 at week 12. At week 2, 63.7% of patients achieved PASI 50. At week 12, 93.2%, 77.4%, and 45.1% of patients achieved PASI 75, PASI 90, and PASI 100, respectively. Mean ± SD change from baseline in DLQI was reduction in 5.91 ± 6.27 at week 2 and 9.76 ± 7.16 at week 12. DLQI 0/1 was achieved by 19.8% and 59.9% of patients at week 2 and 12, respectively.ConclusionIxekizumab was well tolerated and effective in real-world clinical practice in Chinese adults with moderate-to-severe plaque psoriasis.

Project description:The efficacy of ixekizumab, an anti-interleukin-17A (anti-IL-17A) monoclonal IgG4 antibody, was demonstrated in moderate-to-severe psoriasis patients when administered via prefilled syringe (PFS).To evaluate the effect of two drug delivery devices on the pharmacokinetics (PK) of ixekizumab as well as efficacy and safety with both devices.In the first 12 weeks of an open-label, phase 3 study, moderate-to-severe psoriasis patients were randomized to ixekizumab delivery via PFS or autoinjector device. Randomization was stratified by weight (<80 kg, 80-100 kg, >100 kg), injection assistance (yes/no) and injection site (arm, thigh or abdomen). Following a 160-mg initial dose at week 0, patients received subcutaneous 80-mg ixekizumab as a single injection every 2 weeks for 12 weeks. Blood samples were collected following the initial 160-mg dose on days 2, 4, 7, 10 and 14 for PK analysis. Primary PK parameters were maximum concentration (Cmax ) and area under the curve (AUC0-tlast ) where tlast is the time of last sample (14 days ± 24 h). Efficacy was assessed by percent improvement on the Psoriasis Area and Severity Index (PASI) at week 12. Adverse event reporting, vital signs and clinical laboratory data were used to evaluate safety.Of 204 randomized patients, 192 were included in the PK analysis (PFS: 94; autoinjector: 98). The PFS and autoinjector showed similar geometric mean Cmax (90% CI) [15.0 ?g/mL (13.9-16.1) vs. 14.8 ?g/mL (13.8-15.9)] and geometric mean AUC0-tlast (90% CI) [157 ?g × day/mL (147-168) vs. 154 ?g × day/mL (144-165)]. When comparing Cmax and AUC0-tlast of the autoinjector to PFS, the geometric LS mean ratios were 0.97. At week 12, mean percent PASI improvement (via modified baseline observation carried forward) was similar with the PFS (89.3%) and autoinjector (86.9%). Both devices had safety results that were consistent with the known safety profile of ixekizumab.The PK, efficacy and safety of ixekizumab administered subcutaneously by PFS and autoinjector were similar. Clinicaltrials.gov number: NCT01777191 https://clinicaltrials.gov/ct2/show/NCT01777191.

Dataset Information

Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis.

Publications

Early Onset of Clinical Improvement with Ixekizumab in a Randomized, Open-label Study of Patients with Moderate-to-severe Plaque Psoriasis.

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