Dataset Information

Ixekizumab Real-World Effectiveness at 24 Weeks in Patients with Psoriasis: Data from the United States Taltz Customer Support Program.

ABSTRACT:

Introduction

Ixekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24 weeks.

Objective

To describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Customer Support Program.

Methods

This was a 24-week prospective, observational study of commercially insured diagnosis-confirmed adults with PsO. Surveys were completed at weeks 0 (baseline), 2, 4, 8, 12, and 24 and included the Patient Report of Extent of Psoriasis Involvement questionnaire to assess the extent of body surface area (BSA) affected by PsO, itch and pain numeric rating scales, Patient Global Assessment of Disease Severity (PatGA), and Dermatology Life Quality Index (DLQI).

Results

523 patients were included in the analysis. Proportions of patients with ≤ 2% BSA involvement were 34.5%, 40.1%, 50.9%, and 79.9% at weeks 0, 2, 4, and 24, respectively; 54.8% and 75.1% achieved National Psoriasis Foundation preferred (BSA ≤ 1%) and acceptable (BSA ≤ 3% or ≥ 75% improvement) responses at week 12, respectively. Improvements of ≥ 4 points in itch and pain were seen by week 2 in 21.1% and 28.0% of patients, respectively, which increased to 63.1% and 64.8% at week 24. Proportions of patients with PatGA scores of 0 (clear) or 1 were 13.4%, 24.1%, 34.0%, and 69.6% at weeks 0, 2, 4, and 24, respectively; and proportions with DLQI total scores of 0 or 1 [no or minimal impact] were 8.4%, 17.6%, 27.3%, and 53.8% at weeks 0, 2, 4, and 24, respectively.

Conclusion

Patient-reported improvements in BSA, itch, skin pain, dermatology-specific quality of life, and overall PsO severity were seen as early as 2 weeks after initiation and continued through week 24.

SUBMITTER: Gottlieb AB

PROVIDER: S-EPMC10366062 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Ixekizumab Real-World Effectiveness at 24 Weeks in Patients with Psoriasis: Data from the United States Taltz Customer Support Program.

Gottlieb Alice B AB Burge Russel R Malatestinic William N WN Zhu Baojin B Zhao Yunyang Y McCormack Julie J Kimel Miriam M Merola Joseph F JF

Dermatology and therapy 20230711 8

<h4>Introduction</h4>Ixekizumab, a highly selective interleukin-17A monoclonal antibody, was approved for the treatment of moderate-to-severe psoriasis (PsO) in 2016. Limited real-world data are available on its effectiveness from a patient's perspective shortly (2 to 4 weeks) after initiation and upon continuation for 24 weeks.<h4>Objective</h4>To describe patient-reported clinical and quality-of-life outcomes after initiating ixekizumab using data collected from the United States Taltz® Custom ...[more]

PMID: 37434099

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Project description:Background:There is lack of real-world treatment pattern comparison data between ixekizumab and adalimumab which are approved for the treatment of moderate-to-severe plaque psoriasis. Objective:To compare real-world treatment patterns among psoriasis patients initiating ixekizumab or adalimumab in the United States. Methods:Psoriasis patients with ?1 claim for ixekizumab or adalimumab between March 1, 2016, and May 31, 2018, were identified (index date = date of first ixekizumab or adalimumab claim) from the IBM Watson Health MarketScan® databases. Patients were required to be continuously enrolled for ?12 months before the index date and followed for a minimum of 6 months until inpatient death, enrollment end, or study end, whichever occurred first. Treatment persistence, adherence, discontinuation, restart, and switching were analyzed. Inverse probability of treatment weighting and multivariable regression modeling were employed to address cohort imbalances and estimate the adjusted risk of non-persistence, discontinuation, and switching, and the odds of adherence. Results:A total of 646 ixekizumab and 3668 adalimumab users were included and followed for a mean of 14.0 and 16.5 months, respectively. Compared to adalimumab, ixekizumab was associated with 19% lower risk of non-persistence (hazard ratio [HR]=0.81, 95% confidence interval [CI]: 0.69-0.95), 26% lower risk of discontinuation (HR=0.74, 95% CI: 0.62-0.88), and 28% lower risk of switching (HR=0.72, 95% CI: 0.57-0.91). Ixekizumab users had higher odds of medication possession ratio ?80% (odds ratio [OR]=1.36, 95% CI: 1.10-1.69) but similar odds by proportion of days covered ?80% (OR=1.22, 95% CI: 0.98-1.53). Conclusion:Psoriasis patients treated with ixekizumab demonstrated longer persistency, higher adherence and were less likely to discontinue or switch treatment compared to adalimumab users. However, while patients achieving highly adherent threshold significantly differed by MPR ?80%, it did not by PDC ?80%; hence, further analysis using fixed-length follow-up is required.

Project description:BackgroundPrior work showed that patients from the CorEvitas Psoriasis Registry who had previously failed a prior biologic and then initiated ixekizumab demonstrated improvements in disease severity and patient-reported outcomes after 6 months. However, newer therapies such as interleukin-23 inhibitors (IL-23i) were not considered. Here, with more recent data including IL-23i, 6-month effectiveness of ixekizumab following a switch from any biologic was assessed as well as whether 6-month effectiveness of ixekizumab was impacted by prior biologic class.MethodsWe included CorEvitas Psoriasis Registry patients who initiated ixekizumab after discontinuing another biologic therapy and had a corresponding 6-month follow-up visit following ixekizumab initiation (N = 743, 2016-2023). Immediate prior biologic class was categorized as tumor necrosis factor inhibitor (TNFi) or interleukin-12/23 inhibitors (IL-12/23i, n = 405), non-ixekizumab interleukin-17i (IL-17i, n = 237), or IL-23i (n = 101). Adjusted mean changes in body surface area (BSA), Dermatology Life Quality Index (DLQI), itch, and skin pain were calculated for prior biologic class groups using analysis of covariance (ANCOVA). Proportions achieving ≥ 75%, ≥ 90%, and ≥ 100% improvement in Psoriasis Area and Severity Index (PASI75, PASI90, and PASI100, respectively), Investigator's Global Assessment (IGA) 0/1, and DLQI 0/1 were calculated for all patients and compared among prior biologic classes via relative risks (RRs) and 95% confidence intervals (CIs) using multivariable modified Poisson regression.ResultsMean improvements in BSA, DLQI, itch, and skin pain, were 7.6, 3.6, 23.3, and 16.7, respectively, for ixekizumab patients who switched from TNFi or IL-12/23i (all p < 0.05); 6.8, 3.3, 19.6, and 14.1, respectively, for those who switched from non-ixekizumab IL-17i (all p < 0.05); and 7.8, 3.4, 22.2, and 12.8, respectively, for those who switched from IL-23i (all p < 0.05). Overall, 54%, 41%, and 31% of ixekizumab initiators achieved PASI75, PASI90, and PASI100, respectively, 50% maintained or achieved IGA 0/1, and 48% maintained or achieved DLQI 0/1. The prior TNFi or IL-12/23i group was 31% more likely to achieve PASI100 (RR = 1.31, 95% CI 1.01, 1.69) and 32% more likely to maintain or achieve IGA 0/1 (RR = 1.32, 95% CI 1.11, 1.57), but not significantly more likely to achieve PASI90. The prior IL-23i group was 45% more likely to achieve PASI90 (RR = 1.45, 95% CI 1.10, 1.91), 55% more likely to achieve PASI100 (RR = 1.55, 95% CI 1.12, 2.13), and 39% more likely to maintain or achieve IGA 0/1 (RR = 1.39, 95% CI 1.12, 1.73) compared to the prior non-ixekizumab IL-17i group. Achievement of PASI75 and DLQI 0/1 was consistent across the prior TNFi or IL-12/23i, IL-23i, and non-ixekizumab IL-17i groups.ConclusionsThese updated findings with IL-23i data reaffirm that patients with psoriasis who switch to ixekizumab after discontinuing another biologic demonstrate improvement in disease severity and patient-reported outcomes at 6 months in real-world settings. Compared to patients who switched from another IL-17i, patients who switched class from a TNFi or IL-12/23i were more likely to achieve PASI100 and IGA 0/1, and patients who switched class from an IL-23i were more likely to achieve PASI90 in addition to PASI100 and IGA 0/1.

Project description:BackgroundSmall for gestational age (SGA) is a condition in which fetal birthweight is below the 10th percentile for the gestational age, which increases the risk of perinatal morbidity and mortality. Therefore, early screening for each pregnant woman is of great interest. We aimed to develop an accurate and widely applicable screening model for SGA at 21-24 gestational weeks of singleton pregnancies.MethodsThis retrospective observational study included medical records of 23,783 pregnant women who gave birth to singleton infants at a tertiary hospital in Shanghai between 1 January 2018 and 31 December 2019. The obtained data were nonrandomly classified into training (1 January 2018 to 31 December 2018) and validation (1 January 2019 to 31 December 2019) datasets based on the year of data collection. The study variables, including maternal characteristics, laboratory test results, and sonographic parameters at 21-24 weeks of gestation were compared between the two groups. Further, univariate and multivariate logistic regression analyses were performed to identify independent risk factors for SGA. The reduced model was presented as a nomogram. The performance of the nomogram was assessed in terms of its discrimination, calibration, and clinical usefulness. Moreover, its performance was assessed in the preterm subgroup of SGA.ResultsOverall, 11,746 and 12,037 cases were included in the training and validation datasets, respectively. The developed SGA nomogram, comprising 12 selected variables, including age, gravidity, parity, body mass index, gestational age, single umbilical artery, abdominal circumference, humerus length, abdominal anteroposterior trunk diameter, umbilical artery systolic/diastolic ratio, transverse trunk diameter, and fasting plasma glucose, was significantly associated with SGA. The area under the curve value of our SGA nomogram model was 0.7, indicating a good identification ability and favorable calibration. Regarding preterm SGA fetuses, the nomogram achieved a satisfactory performance, with an average prediction rate of 86.3%.ConclusionsOur model is a reliable screening tool for SGA at 21-24 gestational weeks, especially for high-risk preterm fetuses. We believe that it will help clinical healthcare staff to arrange more comprehensive prenatal care examinations and, consequently, provide a timely diagnosis, intervention, and delivery.

Dataset Information

Ixekizumab Real-World Effectiveness at 24 Weeks in Patients with Psoriasis: Data from the United States Taltz Customer Support Program.

Introduction

Objective

Methods

Results

Conclusion

Publications

Ixekizumab Real-World Effectiveness at 24 Weeks in Patients with Psoriasis: Data from the United States Taltz Customer Support Program.

Similar Datasets

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