Nicole Williams

Secukinumab provides better relief from the impact of psoriasis on daily activities and personal relationships than etanercept: results of two phase 3 placebo-controlled randomized clinical trials in moderate-to-severe psoriasis

Abstract Background: Psoriasis can greatly impact patients’ lives, influencing what clothing they wear and impairing their sexual functioning. Objective: To provide a detailed comparison of the impact of secukinumab vs. etanercept on enabling patients with psoriasis to have more normal lives with respect to daily activities (DA) (e.g. choosing clothing) and personal relationships (PR) (e.g. sexual functioning). Methods: Baseline to Week 52 ERASURE and FIXTURE data for secukinumab 300u2009mg and etanercept were analyzed. Treatment differences in mean scores on the DA and PR subscales and items from the Dermatology Life Quality Index were compared. The proportions of subscale and item responders (score =u20090) were compared. Results: Subjects receiving secukinumab (nu2009=u2009572) achieved greater mean improvement in DA and items (q3 and q4) than subjects receiving etanercept (nu2009=u2009326; all pu2009<u2009.01 through Week 52). Subjects receiving secukinumab achieved greater mean improvement in PR and items (q8 and q9) than subjects receiving etanercept (subscale: pu2009<u2009.05 at Weeks 8 and 12). Response rates were significantly higher for secukinumab than for etanercept for DA (all pu2009<u2009.0001) and PR (all pu2009<u2009.05 except Weeks 4 and 36). Conclusions: Secukinumab 300u2009mg provides greater improvements and more effective relief from psoriasis impact on DA and PR than etanercept.

Secukinumab demonstrates greater sustained improvements in daily activities and personal relationships than ustekinumab in patients with moderate-to-severe plaque psoriasis: 52-week results from the CLEAR study

Psoriasis can greatly impact patients’ lives by influencing clothing worn as well as by impairing sexual functioning. Secukinumab, a human monoclonal antibody selectively neutralizing interleukin‐17A, has demonstrated good efficacy and safety in the treatment of moderate‐to‐severe psoriasis and psoriatic arthritis with a rapid onset of action and sustained response.

Psychometric validation of a patient-reported measure of physical functioning in sporadic inclusion body myositis

Introduction: To assess self‐reported physical functioning in patients with sporadic inclusion body myositis (sIBM), the sIBM Physical Functioning Assessment (sIFA) was developed. This research establishes the validity, reliability, and responsiveness of the sIFA in patients with sIBM. Methods: Data from 3 small, noninterventional, observational studies were analyzed. Several measures of physical function were included to assess validity. Reliability (Cronbach alpha, test–retest intraclass correlations), construct validity (correlations, analyses of variance), and responsiveness (effect size estimates) were evaluated. Results: Cronbach alphas (range = 0.86–0.91) and test–retest reliability (0.91) were highly satisfactory. Correlations with other measures provided evidence of convergent validity. sIBM patients able to walk without assistive devices scored significantly better on the sIFA (means = 36.0–47.05) than those who required power mobility or wheelchairs (means = 54.9–71.5), demonstrating the discriminating ability of the sIFA. Effect size estimates of responsiveness suggested mild functional progression. Conclusions: Psychometric analyses of the sIFA demonstrate satisfactory reliability, validity, and responsiveness. Muscle Nerve 54: 658–665, 2016

Psychometric validation of the depression and family functioning scale

Abstract Objective A new patient-reported outcome (PRO) measure developed to assess the impact of major depressive disorder (MDD) on partner and family interactions and quality of relationships, the Depression and Family Functioning Scale (DFFS), was analyzed to establish its reliability, validity, and responsiveness. Methods Data from a multi-center, prospective, 2-year observational study were analyzed to assess the psychometric properties of the DFFS in patients with MDD (nBaselineu2009=u2009478; nMonth2u2009=u2009433). Measures administered to assess validity included the Sheehan Disability Scale (SDS), Arizona Sexual Experiences Scale (ASEX) and Short Form Health Survey–12 (SF-12). Reliability (Cronbach’s alphas and intra-class correlations), construct validity (factor analysis and correlations), discriminating ability (analyses of variance), and responsiveness (standardized effect size estimates) were evaluated. Results Principal components analyses indicated a single underlying dimension, confirmed by highly satisfactory Cronbach’s alphas (αBaselineu2009=u20090.85, αMonth2u2009=u20090.89). The DFFS demonstrated satisfactory test–re-test reliability in patients with the same SDS family life/home responsibilities ratings at baseline and month 2 (intraclass correlationu2009=u20090.75). Correlations with other measures showed convergent and divergent validity; e.g., the DFFS correlated better with SF-12 mental component scores (rBaselineu2009=u2009−0.35, rMonth2u2009=u2009−0.49) than with SF-12 physical component scores (rBaselineu2009=u2009−0.05, rMonth2u2009=u2009−0.31). Hypothesis tests were generally as predicted; many were statistically significant, substantiating DFFS discriminating ability. Standardized effect size estimates of responsiveness ranged from 0.44–0.84, demonstrating that the items were capable of detecting change. Conclusions The psychometric analyses support the reliability, validity, and responsiveness of the DFFS and its usefulness for assessing the impact of depression on family functioning. The DFFS can potentially provide important information not captured in clinical practice and facilitate more comprehensive evaluation of MDD treatments.

Psychometric evaluation of a caregiver diary for the assessment of symptoms of respiratory syncytial virus

BackgroundThere are no clinical outcome assessment (COA) tools developed in accordance with Food and Drug Administration (FDA) guidance suitable for the evaluation of symptoms associated with respiratory syncytial virus (RSV) infection among infants. The Gilead RSV Caregiver Diary (GRCD) is being developed to fulfill this need; the present research evaluates the GRCD and documents its reliability, validity, and responsiveness among children <u200924xa0months of age with acute RSV infection.MethodsA prospective, observational study was conducted in the United States during the 2014–2015 northern hemisphere winter season. Subjects were <u200924-month, full-term, previously healthy infants with confirmed RSV infection and ≤5xa0days of symptoms. The GRCD was completed twice daily for 14xa0days by caregivers. Additional data were collected during the initial visit, subsequent visits, and end-of-study interview. Test-retest reliability (kappa and intraclass correlation coefficients [ICCs]), construct validity (correlations and factor analyses), discriminating ability (analyses of variance and chi-square), and responsiveness (effect sizes and standardized response means) were evaluated.ResultsA total of 103 subjects were enrolled (mean age 7.4u2009±u20095.3xa0months). GRCD items were grouped into different subscales according to question content, which, with the exception of the behavior impact domain (ICCu2009=u20090.43), demonstrated internal consistency (alphasu2009=u20090.78–0.94) and test-retest reliability (ICCsu2009=u20090.77–0.94). Hypothesized correlations with parent global ratings of RSV severity ranged from 0.45 to 0.70 and provided support for construct validity. Support for discriminating ability was limited. Effect sizes ranged from −u20091.48 to −u20094.40, indicating the GRCD was responsive to change.ConclusionsThese psychometric analyses support the validity, reliability, and responsiveness of the GRCD for assessing RSV symptoms in children <u200924xa0months of age.

Effect of secukinumab on quality of life and psoriasis-related symptoms: A comparative analysis versus ustekinumab from the CLEAR 52-week study

Background: Secukinumab has demonstrated greater sustained skin clearance than ustekinumab through week 52, greater improvement in symptoms and health‐related quality of life, and comparable safety profile. Objective: To assess the impact of secukinumab versus that of ustekinumab on complete relief from psoriasis‐related symptoms, time to response in terms of health‐related quality of life, and cumulative benefit among patients with moderate‐to‐severe plaque psoriasis. Methods: Psoriasis‐related pain, itching, and scaling and the Dermatology Life Quality Index (DLQI) score were compared between treatments on the basis of time to complete relief of symptoms and time to DLQI response in the CLEAR trial. Cumulative benefit over 52 weeks based on Psoriasis Area and Severity Index score, symptom relief, and DLQI response were evaluated by area under the curve analysis. Results: Significantly more patients treated with secukinumab achieved complete relief of pain at weeks 16 and 52 (all P < .05). Complete relief of itching and scaling occurred significantly faster with secukinumab (median, 4 weeks faster for itching and 8 weeks faster for scaling [P < .001]). Response as measured by the DLQI was 4 weeks faster with secukinumab (P < .0001). Cumulative benefits were greater with secukinumab (all P < .05). Limitations: Analyses were post hoc. Conclusion: This patient‐reported outcome analysis confirms greater and sustained benefits of secukinumab versus those of ustekinumab treatment on patients lives.