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3.
Br J Dermatol ; 184(6): 1047-1058, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-32880909

RESUMEN

BACKGROUND: Significantly more patients with moderate-to-severe plaque psoriasis treated with the interleukin (IL)-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab in the IXORA-R head-to-head trial achieved 100% improvement in Psoriasis Area and Severity Index (PASI 100) at week 12. OBJECTIVES: To compare skin and nail clearance and patient-reported outcomes for ixekizumab vs. guselkumab, up to week 24. METHODS: IXORA-R enrolled adults with moderate-to-severe plaque psoriasis, defined as static Physician's Global Assessment ≥ 3, PASI ≥ 12 and involved body surface area ≥ 10%. Statistical comparisons were performed using the Cochran-Mantel-Haenszel test stratified by pooled site. Time-to-first-event comparisons were performed using Kaplan-Meier analysis, and P-values were generated using adjusted log-rank tests stratified by treatment group. Cumulative days at clinical and patient-reported responses were compared by ancova. The trial was registered with ClinicalTrials.gov (NCT03573323). RESULTS: Of the 1027 patients randomly assigned, 90% completed the trial (465 of 520 ixekizumab and 459 of 507 guselkumab). As early as week 2 and through week 16, more patients on ixekizumab achieved PASI 100 (P < 0·01). At week 24, ixekizumab was noninferior to guselkumab (50% vs. 52%, difference -2·3%), with no statistically significant difference in PASI 100 (P = 0·41). More patients receiving ixekizumab showed completely clear nails at week 24 (52% vs. 31%, P = 0·007). The median time to first PASI 50/75/90 and PASI 100 were 2 and 7·5 weeks shorter, respectively, for patients on ixekizumab vs. guselkumab (P < 0·001). Patients on ixekizumab also had a greater cumulative benefit, with more days at PASI 90 and 100, with Dermatology Life Quality Index of 0 or 1, and itch free (P < 0·05). The frequency of serious adverse events was 3% for each group, with no new safety signals. CONCLUSIONS: Ixekizumab was noninferior to guselkumab in complete skin clearance and superior in clearing nails at week 24. Ixekizumab cleared skin more rapidly in patients with moderate-to-severe plaque psoriasis, with a greater cumulative benefit, than guselkumab. Overall, the safety findings were consistent with the known safety profile for ixekizumab.


Asunto(s)
Psoriasis , Adulto , Anticuerpos Monoclonales Humanizados , Método Doble Ciego , Humanos , Psoriasis/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
4.
Clin Exp Dermatol ; 46(4): 651-656, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33175413

RESUMEN

BACKGROUND: Previous studies have associated alopecia areata (AA) with a number of comorbidities. However, the timing between AA and the development of such comorbidities remains poorly understood. AIM: To examine the temporal relationship between AA diagnosis and comorbidity development in Denmark. METHODS: A Danish nationwide register-based cohort study was performed on all individuals diagnosed with AA between 2007 and 2016 (n = 1843), and each patient was matched for age and sex with 10 healthy controls (HCs). Time between AA and comorbidity development was assessed, and incidence rate ratios (IRRs) were calculated to assess risk of comorbidity following initial AA diagnosis. RESULTS: Use of antidepressant and anxiolytic drugs were mostly started prior to AA diagnosis, and these drugs were used more frequently before than after diagnosis with AA. Additional frequent comorbidities included thyroid disease, hyperlipidaemia, type 2 diabetes and asthma. Most comorbidities occurred prior to AA diagnosis; however, among those that occurred after AA diagnosis, antidepressants (IRR = 1.26, 95% CI 1.01-1.56), anxiolytics (IRR = 1.55, 95% CI 1.17-2.05), atopic dermatitis (AD; IRR = 9.41, 95% CI 4.00-22.16), asthma (IRR = 2.17, 95% CI 1.46-3.21), vitiligo (IRR = 30.35, 95% CI 6.13-150.39), Crohn disease (CD; IRR = 3.04; 95% CI 1.22-7.56) and thyroid disease (IRR = 2.38; 95% CI 1.72-3.29) occurred more frequently among patients with AA compared with controls. CONCLUSION: A diagnosis of AA was significantly associated with risk of several comorbidities, most notably vitiligo, AD and CD. Nonetheless, the majority of patients appeared to have developed these comorbidities prior to AA diagnosis, suggesting that a thorough medical history screening by dermatologists at the initial visit may be appropriate.


Asunto(s)
Alopecia Areata/complicaciones , Depresión/epidemiología , Vitíligo/epidemiología , Alopecia Areata/epidemiología , Alopecia Areata/psicología , Ansiedad/epidemiología , Asma/epidemiología , Estudios de Casos y Controles , Estudios de Cohortes , Comorbilidad , Dinamarca/epidemiología , Diabetes Mellitus Tipo 2/epidemiología , Humanos , Hiperlipidemias/epidemiología , Incidencia , Sistema de Registros , Enfermedades de la Tiroides/epidemiología
6.
Phys Rev Lett ; 124(10): 103901, 2020 Mar 13.
Artículo en Inglés | MEDLINE | ID: mdl-32216411

RESUMEN

Carrying orbital angular momentum per photon, the optical vortex has elicited widespread interest. Here, we demonstrate that dual coaxial longitudinal polarization vortices can appear upon a nonparaxial propagation of a tightly focused Pancharatnam-Berry tailored Laguerre-Gaussian beam. Most importantly, it is capable of accessing arbitrary independent topological charges for both vortices, as well as predesigned tunable spacing distances between them.

7.
J Eur Acad Dermatol Venereol ; 34(6): 1257-1262, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31919919

RESUMEN

BACKGROUND: Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health. OBJECTIVE: To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12. METHODS: This post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ). RESULTS: At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline. CONCLUSION: Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.


Asunto(s)
Fármacos Dermatológicos , Psoriasis , Salud Sexual , Adulto , Anticuerpos Monoclonales Humanizados , Fármacos Dermatológicos/uso terapéutico , Método Doble Ciego , Genitales , Humanos , Dolor/tratamiento farmacológico , Psoriasis/complicaciones , Psoriasis/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
9.
Br J Dermatol ; 182(6): 1348-1358, 2020 06.
Artículo en Inglés | MEDLINE | ID: mdl-31887225

RESUMEN

BACKGROUND: Patients with psoriasis value rapid and complete skin clearance. No head-to-head studies have focused on early responses to interleukin (IL)-17 vs. IL-23 inhibitors. OBJECTIVES: To compare early and complete skin clearance by the IL-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab. METHODS: IXORA-R, a 24-week, randomized, double-blinded study, enrolled adults with moderate-to-severe plaque psoriasis [static Physician's Global Assessment of Disease (sPGA) score of ≥ 3, Psoriasis Area and Severity Index (PASI) ≥ 12, and ≥ 10% body surface area]. Patients were randomized (1 : 1) to receive the approved dose of subcutaneous ixekizumab or guselkumab. Primary end point was 100% improvement in PASI (PASI 100) at week 12. Major secondary end points included other levels of improved PASI and sPGA at different time points. Comparisons were made using the Cochran-Mantel-Haenszel test with a multiple testing strategy. Nonresponder imputation was used for missing data. After the completion of the study, the final secondary end point (PASI 100 at 24 weeks) and safety data through week 24 will be reported. RESULTS: In total, 1027 patients were randomized. The primary end point PASI 100 at week 12 was met [215/520 ixekizumab (41%); 126/507 guselkumab (25%); P < 0·001]. All major secondary end points measured up to week 12 were met, including PASI 50 at week 1 and PASI 75 at week 2. Serious adverse event frequency was 3% for each group; no new safety signals were identified. CONCLUSIONS: Ixekizumab was superior to guselkumab for rapidly improving signs and symptoms in patients with moderate-to-severe plaque psoriasis by week 12. Adverse events were similar to previous ixekizumab and guselkumab studies. Compared with the IL-23 inhibitor guselkumab, ixekizumab can offer complete skin clearance more rapidly to patients with moderate-to-severe plaque psoriasis. What's already known about this topic? Patients with plaque psoriasis desire both high levels of clearance and rapid onset of treatment effects. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, has demonstrated greater and faster skin clearance than etanercept and ustekinumab, with consistent long-term efficacy, safety and durability of response. Clinical trial data and systematic reviews have suggested that IL-17 inhibitors can improve a patient's psoriasis more rapidly than IL-23 inhibitors. What does this study add? The head-to-head study design directly compares the efficacy and speed of response of ixekizumab and the IL-23 inhibitor guselkumab in moderate-to-severe plaque psoriasis. The primary end point was met, showing superiority of ixekizumab over guselkumab for achieving complete skin clearance at week 12. The safety profile of ixekizumab was consistent with previous studies. Ixekizumab can deliver patients complete skin clearance and improved quality of life more rapidly than guselkumab.


Asunto(s)
Psoriasis , Calidad de Vida , Adulto , Anticuerpos Monoclonales Humanizados , Método Doble Ciego , Humanos , Psoriasis/tratamiento farmacológico , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
10.
J Eur Acad Dermatol Venereol ; 34(1): 39-46, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31465593

RESUMEN

Several novel biologics are available or in development for moderate-to-severe plaque psoriasis. These drugs may differ in time until Psoriasis Area and Severity Index (PASI) response is obtained. In this systematic review, we examined the time to onset of action for interleukin (IL)-17 and IL-23 agents in the treatment of psoriasis. The primary objective was the weighted mean time needed for 25% and 50% of patients with psoriasis to achieve PASI90. The medical databases PubMed, Web of Science and EMBASE were searched using the following terms: psoriasis AND (ixekizumab OR secukinumab OR brodalumab OR risankizumab OR guselkumab OR tildrakizumab). A total of 27 studies were included for data extraction and qualitative synthesis, and 26 of these were quantitatively analysed. The shortest time to 25% and 50% of patients to achieved PASI90 were seen with brodalumab 210 mg every 2 weeks (Q2W; 3.5 weeks and 6.2 weeks, respectively) followed by ixekizumab 80 mg Q2W (4.1 and 7.4 weeks, respectively) and ixekizumab 80 mg Q4W (4.6 and 8.1 weeks, respectively) dosages. In conclusion, clinical trials yielded shorter time to onset of action in studies assessing approved dosing ranges of IL-17 inhibitors compared with studies assessing IL-23 inhibitors.


Asunto(s)
Fármacos Dermatológicos/farmacología , Interleucina-17/antagonistas & inhibidores , Interleucina-23/antagonistas & inhibidores , Psoriasis/tratamiento farmacológico , Anticuerpos Monoclonales/farmacología , Anticuerpos Monoclonales Humanizados/farmacología , Productos Biológicos/farmacología , Humanos
11.
Br J Dermatol ; 181(5): 976-982, 2019 11.
Artículo en Inglés | MEDLINE | ID: mdl-30815849

RESUMEN

BACKGROUND: Palmoplantar pustulosis (PPP) is a chronic pustular skin condition on the palms and soles. The disease is often seen in combination with plaque psoriasis, and whether PPP is a variant of psoriasis has been debated. The disease prevalence of PPP and co-occurring psoriasis is not yet established and the patient group remains understudied. OBJECTIVES: To estimate the prevalence of PPP and co-occurring psoriasis in three population-based cohorts and to provide information on patient demographics and characteristics. METHODS: Administrative healthcare registries and insurance databases from the U.S.A., Denmark and Germany were used as data sources. Patients with PPP were defined by a single International Classification of Diseases 10th Revision code for PPP during a 1-year period. Information regarding co-occurring plaque psoriasis and other comorbidities was extracted. Furthermore, use of antipsoriatic medication was identified. RESULTS: In total 1435, 751 and 1832 patients with PPP were identified in the U.S., Danish and German populations, with estimated 1-year prevalences of 0·009%, 0·005% and 0·08%, respectively. Plaque psoriasis was present in 14·2-61·3% of patients with PPP. Patients with co-occurring psoriasis had an overall higher prevalence of psoriatic arthritis. Similarly, medication use was more prevalent in patients with PPP with co-occurring psoriasis, and especially pronounced was the use of biologic therapies. CONCLUSIONS: This large observational study on patients with PPP provides detailed information regarding patient demographics, comorbidities and medication use. The 1-year prevalence of PPP varied in the three studied populations, possibly due to differences in diagnostics and recording practices. Psoriasis frequently co-occurred in patients with PPP. What's already known about this topic? Palmoplantar pustulosis (PPP) is a skin disease of the palms of the hands and soles of the feet and is known to be related to psoriasis. Whether PPP is a distinct disease or a variant of psoriasis is not yet established. The condition is understudied in terms of disease prevalence, disease predictors, patient characteristics and comorbidity. What does this study add? In this study using data from three large population-based cohorts we found low prevalence rates (< 0·1%) of PPP. The prevalence of psoriasis was estimated at between 14·2% and 61·3% in patients with psoriasis. Patients with PPP with co-occurring psoriasis have a higher prevalence of psoriatic arthritis and use of antipsoriatic drugs.


Asunto(s)
Artritis Psoriásica/epidemiología , Factores Biológicos/uso terapéutico , Psoriasis/epidemiología , Enfermedades Cutáneas Vesiculoampollosas/epidemiología , Reclamos Administrativos en el Cuidado de la Salud/estadística & datos numéricos , Adulto , Anciano , Artritis Psoriásica/tratamiento farmacológico , Comorbilidad , Dinamarca/epidemiología , Prescripciones de Medicamentos/estadística & datos numéricos , Femenino , Alemania/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Estudios Prospectivos , Psoriasis/tratamiento farmacológico , Enfermedades Cutáneas Vesiculoampollosas/tratamiento farmacológico , Estados Unidos/epidemiología
12.
J Eur Acad Dermatol Venereol ; 33(2): 318-324, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29846976

RESUMEN

BACKGROUND: The clinical meaningfulness of improvements in the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-PsO) reported by patients with psoriasis in response to treatment is unknown due to the lack of any publications that report minimal clinically importance differences (MCID) for WPAI-PsO outcomes. OBJECTIVE: To determine the MCIDs for the work productivity loss and activity impairment domains of the Work Productivity and Activity Impairment Questionnaire for Psoriasis (WPAI-PsO) using results from three Phase 3 trials of ixekizumab. METHODS: MCIDs for WPAI-PsO domains were derived using treatment agnostic data from patients participating in UNCOVER-1/-2/-3. The analysis included patients randomized to placebo and two ixekizumab treatment groups (ixekizumab either every 2 weeks or 4 weeks) from the trials. WPAI-PsO was administered at baseline and Week 12 for UNCOVER-1/-2/-3 and at Weeks 24, 36, 52 and 60 in UNCOVER-1/-2. MCIDs for the WPAI-PsO domains through Week 12 were derived using an anchor-based method supplemented with the distribution-based method. Anchors included 75%/90%/100% improvement in Psoriasis Area and Severity Index, Static Physicians Global Assessment (sPGA[0] and sPGA[0,1]) and Dermatology Life Quality Index MCID). MCIDs were triangulated using receiver operating characteristics (ROC) and distribution-based methods. RESULTS: The analyses included 3126 patients (Placebo: 792, Ixekizumab: 2334). All anchors were shown to be valid. Significant differences in the domains of WPAI-PsO were observed between patients achieving clinically meaningful improvement in the validated anchors (all P-values < 0.001). ROC analyses suggested a 20% improvement in the work productivity loss or activity impairment components best represented the benefit of meeting a clinical meaningful improvement in the validated anchors. The distribution-based method supported the results of the anchor-based method. CONCLUSION: The MCIDs for both the work productivity loss and the activity impairment domains of WPAI-PsO were estimated to be 20% in patients with PsO.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Diferencia Mínima Clínicamente Importante , Psoriasis/tratamiento farmacológico , Encuestas y Cuestionarios , Rendimiento Laboral , Absentismo , Adulto , Productos Biológicos/farmacología , Productos Biológicos/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Evaluación de la Discapacidad , Eficiencia/efectos de los fármacos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/fisiopatología , Curva ROC , Índice de Severidad de la Enfermedad , Perfil de Impacto de Enfermedad , Resultado del Tratamiento
13.
Br J Dermatol ; 179(4): 844-852, 2018 10.
Artículo en Inglés | MEDLINE | ID: mdl-29747232

RESUMEN

BACKGROUND: Genital psoriasis (GenPs) is a common, debilitating and difficult-to-treat manifestation of plaque psoriasis. However, few controlled, interventional studies of GenPs exist. OBJECTIVES: To determine the efficacy of ixekizumab vs. placebo in patients with moderate-to-severe GenPs with ≥ 1% involved body surface area (BSA). METHODS: Patients with moderate-to-severe GenPs, defined as a baseline static Physician's Global Assessment of Genitalia (sPGA-G) score of ≥ 3, with BSA ≥ 1% were randomized 1 : 1 to receive placebo (n = 74) or the recommended dosing of ixekizumab (n = 75). Major outcomes included the percentage of patients achieving 0 or 1 scores on the sPGA-G (primary end point), overall sPGA, GenPs Sexual Frequency Questionnaire (GenPs-SFQ) item 2, and ≥ 3-point improvement from baseline on the GenPs itch numerical rating scale. RESULTS: At week 12, ixekizumab was superior to placebo for sPGA-G 0/1 (73% vs. 8%, P < 0·001), overall sPGA 0/1 (73% vs. 3%, P < 0·001), GenPs-SFQ item 2 score of 0 or 1 (78% vs. 21%, P < 0·001) and genital itch (60% vs. 8%, P < 0·001). No candidiasis was reported, no deaths occurred and one (1%) serious adverse event was reported in a patient receiving placebo. CONCLUSIONS: Ixekizumab was superior to placebo for the treatment of moderate-to-severe GenPs with BSA ≥ 1%. The safety profile of ixekizumab was consistent with previous studies in moderate-to-severe plaque psoriasis.


Asunto(s)
Anticuerpos Monoclonales Humanizados/administración & dosificación , Fármacos Dermatológicos/administración & dosificación , Prurito/tratamiento farmacológico , Psoriasis/tratamiento farmacológico , Adulto , Anticuerpos Monoclonales Humanizados/efectos adversos , Fármacos Dermatológicos/efectos adversos , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Femenino , Genitales , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Placebos/administración & dosificación , Placebos/efectos adversos , Prurito/diagnóstico , Prurito/etiología , Psoriasis/complicaciones , Psoriasis/diagnóstico , Psoriasis/psicología , Calidad de Vida , Índice de Severidad de la Enfermedad , Salud Sexual , Resultado del Tratamiento
14.
J Eur Acad Dermatol Venereol ; 32(1): 68-72, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-28881462

RESUMEN

BACKGROUND: Facial psoriasis was reported in 17-68% of patients with psoriasis and shown to have a negative impact on patients' personal and health-related quality of life (HRQoL). OBJECTIVES: To explore the association of facial psoriasis with patients' HRQoL and to assess the relationship between ixekizumab (IXE) and improvement in facial psoriasis and changes in HRQoL. METHODS: This work reports the combined results of two phase III multicentre, randomized, double-blind, placebo-controlled, active-comparator trials in patients with moderate-to-severe psoriasis. Patients received placebo, etanercept (ETN; 50 mg twice weekly) or IXE [80 mg every 4 weeks (Q4W) or every 2 weeks (Q2W)] for up to 12 weeks following an initial 160-mg dose. HRQoL parameters were analysed based on facial psoriasis status at baseline using analysis of covariance models. Improvement was assessed as percentage of patients with no facial psoriasis. RESULTS: The combined database included 1133 patients with facial psoriasis and 1437 without. Patients treated with IXE whose facial psoriasis cleared had improved Dermatology Life Quality Index 0.1 responses (P < 0.01) compared with patients with facial psoriasis at Week 12. At Week 12, clearance of facial psoriasis compared with the presence of facial psoriasis was independently associated with significantly better improvement in Psoriasis Skin Appearance Bothersomeness scores in the IXE Q2W treatment group (P < 0.01). At Week 12, facial clearance and overall Psoriasis Area Severity Index (PASI) improvement were observed in significant numbers of patients treated with IXE compared with ETN and placebo. Facial psoriasis clearance at Week 12 in patients treated with IXE or ETN was positively associated with PASI75 and PASI90 achievement. CONCLUSION: Facial psoriasis had a larger negative impact on HRQoL than no facial psoriasis. Facial psoriasis clearance was associated with improved HRQoL. Significantly more IXE-treated patients had rapid facial clearance vs. ETN and PBO, which led to better clinical outcomes.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Dermatosis Facial/tratamiento farmacológico , Psoriasis/tratamiento farmacológico , Calidad de Vida , Adulto , Método Doble Ciego , Etanercept/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad
15.
J Eur Acad Dermatol Venereol ; 31(11): 1867-1875, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28573743

RESUMEN

BACKGROUND: Psoriasis symptoms may decrease quality of life for patients. Skin-related personal relationship difficulties in psoriasis patients are common, under-reported and poorly understood. OBJECTIVE: To assess the effect of ixekizumab (IXE) treatment on skin-related personal relationship difficulties in patients with moderate-to-severe psoriasis. METHODS: Pooled data (N = 2570) on skin-related relationship problems were obtained from two large phase 3 trials (UNCOVER-2 and UNCOVER-3) in patients with moderate-to-severe plaque psoriasis randomized to subcutaneous placebo (PBO, N = 361), etanercept (ETN; 50 mg twice weekly, N = 740), or 80 mg IXE as one injection every 4 (IXEQ4W, N = 733) or 2 weeks (IXEQ2W, N = 736) for 12 weeks, following a 160-mg initial dose. The Dermatology Life Quality Index (DLQI) Personal Relationships Domain (PRD) (Items 8 and 9) was used to assess how much the skin caused any personal relationship difficulties at weeks 0, 2, 4 and 12. Improvement was compared for IXE vs PBO and ETN using logistic models. Factors associated with improvement were assessed using multiple linear regressions. DLQI Item 9, assessing sexual difficulties, was also analysed separately. RESULTS: PRD scores (mean ± standard deviation) at baseline were similar across all treatment groups (PBO: 1.8 ± 1.9; ETN: 1.7 ± 1.8; IXEQ4W: 1.6 ± 1.8; IXEQ2W: 1.7 ± 1.8). Treatment with IXE rapidly and significantly improved the mean PRD score compared to PBO and ETN (P < 0.001 at all time points). Baseline PRD score was the strongest negative predictor of improvement. IXE enabled significantly more patients with moderate-to-severe plaque psoriasis to reduce their skin-related sexual difficulties at Week 12 compared to PBO (P < 0.001) or ETN (P < 0.001). CONCLUSION: Ixekizumab improves patient-reported skin-related PRD difficulties in patients with moderate-to-severe psoriasis.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Psoriasis/tratamiento farmacológico , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Psoriasis/fisiopatología , Índice de Severidad de la Enfermedad
16.
Osteoporos Int ; 28(8): 2485-2494, 2017 08.
Artículo en Inglés | MEDLINE | ID: mdl-28536737

RESUMEN

Our aim was to evaluate the gap in osteoporosis treatment and the impact of osteoporosis treatment on subsequent fragility fractures. We found osteoporosis medication use lowered risk of subsequent fractures by 21% and that black race, higher CCI scores, dementia, and kidney diseases reduced the likelihood of osteoporosis medication use. INTRODUCTION: The goal of this study was to evaluate the predictors of osteoporosis medication use and compare the risk of fragility fractures within 1 year of a fragility fracture between osteoporosis treated and untreated women. METHODS: We conducted a retrospective, observational cohort study using the national Medicare database. Elderly women (≥65 years) who were hospitalized or had an outpatient/ER service for fragility fracture between January 1, 2011 and December 31, 2011 were included. The outcomes of interest were the correlates of and time-to-osteoporosis medication use and risk of a subsequent fracture within 12 months for treated and untreated women. Cox regression was used to evaluate the predictors of treatment use and the risk of fracture based on treatment status. RESULTS: Women (28,722) (27.7%) were treated with osteoporosis medication within 12 months of index fracture, and 74,979 (72.2%) were untreated. A number of patient characteristics were associated with a reduced likelihood of osteoporosis medication use, including black race, higher Charlson comorbidity index scores, presence of dementia, and kidney diseases in the baseline. The predictor most strongly and positively associated with osteoporosis medication use after fracture was osteoporosis medication use before fragility fracture (HR = 7.87; 95% CI 7.67-8.07). After adjusting for baseline characteristics, osteoporosis medication use lowered the risk of subsequent fractures by 21% (HR = 0.79, 95% CI 0.75-0.83) over 12 months compared to women without treatment. CONCLUSIONS: Demographics and clinical characteristics were strong predictors of osteoporosis medication use. In the US Medicare population, osteoporosis treatment significantly reduced the risk of fragility fractures.


Asunto(s)
Conservadores de la Densidad Ósea/administración & dosificación , Osteoporosis Posmenopáusica/tratamiento farmacológico , Fracturas Osteoporóticas/prevención & control , Anciano , Anciano de 80 o más Años , Conservadores de la Densidad Ósea/uso terapéutico , Bases de Datos Factuales , Utilización de Medicamentos/estadística & datos numéricos , Femenino , Humanos , Medicare/estadística & datos numéricos , Osteoporosis Posmenopáusica/complicaciones , Osteoporosis Posmenopáusica/epidemiología , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/etiología , Recurrencia , Estudios Retrospectivos , Medición de Riesgo/métodos , Sensibilidad y Especificidad , Estados Unidos/epidemiología
17.
J Eur Acad Dermatol Venereol ; 31(9): 1483-1490, 2017 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-28294430

RESUMEN

BACKGROUND: Patients with moderate-to-severe psoriasis report impaired health-related quality of life (HRQoL). OBJECTIVE: To assess speed of onset of ixekizumab-induced clinically relevant improvement in HRQoL. METHODS: This post hoc analysis used pooled data from patients randomized in UNCOVER-2 and UNCOVER-3, and treated with 80 mg ixekizumab every 2 weeks (IXEQ2W), 80 mg ixekizumab every 4 weeks (IXEQ4W), 50 mg etanercept (ETN) twice weekly or placebo (PBO) for 12 weeks. HRQoL and pruritus were assessed using the Dermatology Life Quality Index (DLQI) and Itch Numeric Rating Scale (NRS), respectively. Minimally clinical important differences (MCID) in DLQI and Itch NRS were defined as ≥5-point and ≥4-point improvements from baseline, respectively. Time to response from randomization was estimated using Kaplan-Meier methodology and the log-rank test. Hazard ratios between treatments were calculated using a Cox proportional hazards regression model adjusting for studies. RESULTS: A total of 2570 patients were included: 361 PBO; 740 ETN; 733 IXEQ4W and 736 IXEQ2W. Significantly greater differences in time to DLQI ≥5 point or Itch NRS ≥4 point improvement for IXEQ2W or IXEQ4W compared with ETN and PBO (P < 0.001) were observed. The median time when 50% of patients reached a ≥5-point reduction in DLQI was shorter for ixekizumab-treated patients (2 weeks, both schedules) compared with ETN- (4 weeks) or PBO-treated (>12 weeks) patients. Likewise, the median time when 50% of patients reached a ≥4-point reduction in Itch NRS was shorter for ixekizumab-treated patients (2 weeks, both schedules) compared with ETN- (8 weeks) or PBO-treated (>12 weeks) patients. Significantly more ixekizumab-treated patients were likely to achieve MCIDs in DLQI or itch reduction compared with ETN or PBO after 12 weeks of treatment. CONCLUSION: Ixekizumab-treated patients achieved more rapid improvements both in HRQoL and itch compared with patients treated with ETN and PBO.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Fármacos Dermatológicos/uso terapéutico , Prurito/tratamiento farmacológico , Calidad de Vida , Adulto , Etanercept/uso terapéutico , Femenino , Humanos , Masculino , Persona de Mediana Edad , Placebos , Prurito/fisiopatología
18.
J Eur Acad Dermatol Venereol ; 31(6): 1004-1013, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28190255

RESUMEN

BACKGROUND: Continuous treatment is recommended for patients with moderate-to-severe psoriasis; however, treatment may need to be interrupted in routine clinical practice. OBJECTIVE: To assess outcomes in patients continuously treated with ixekizumab versus those who interrupted therapy and were subsequently retreated with ixekizumab (IXE). METHODS: This analysis used data pooled from two phase 3 trials, UNCOVER-1 and UNCOVER-2. Patients were randomized to placebo (PBO), IXE every 4 (Q4W) or IXE every 2 weeks (Q2W) for 12 weeks. Patients with a static Physician's Global Assessment (sPGA) 0, 1 at Week 12 were rerandomized to IXEQ4W, IXE every 12 weeks (not presented) or PBO. We examined outcomes in patients who were continuously treated (IXEQ2W/IXEQ4W; IXEQ4W/IXEQ4W) or withdrawn (IXEQ2W/PBO; IXEQ4W/PBO), and in patients who were withdrawn and retreated with IXEQ4W for 24 weeks after disease relapse (sPGA ≥3). RESULTS: A total of 1226 treated patients achieved an sPGA 0, 1 at Week 12 and entered the maintenance phase; of these patients, 402 and 416 were rerandomized to PBO and IXEQ4W, respectively. Among patients interrupting treatment, 157 (82.2%) of IXEQ4W/PBO and 176 (83.4%) of IXEQ2W/PBO had an sPGA ≥3 by Week 60; median time to relapse was approximately 20 weeks irrespective of induction dose. At Week 60, continuously treated patients maintained high levels of PASI and sPGA responses (90.0% PASI 75 IXEQ2W/IXEQ4W; 81.9% sPGA 0, 1 IXEQ2W/IXEQ4W, non-responder imputation). After 24 weeks of retreatment with IXEQ4W (IXEQ2W/PBO/IXEQ4W and IXEQ4W/PBO/IXEQ4W), 87.0% (107 of 123) and 95.1% (97 of 102) (observed), respectively, of patients recaptured PASI 75 and 70.7% (104 of 147) and 82.3% (107 of 130) (observed) recaptured an sPGA 0, 1. Overall, adverse events in continuously treated and retreated patients were comparable. CONCLUSION: High levels of response were sustained with continuous ixekizumab treatment through 60 weeks. Most patients who were withdrawn experienced disease relapse, and most of those patients recaptured response after 24 weeks of retreatment.


Asunto(s)
Anticuerpos Monoclonales Humanizados/uso terapéutico , Psoriasis/tratamiento farmacológico , Método Doble Ciego , Humanos , Placebos
19.
Osteoporos Int ; 28(3): 799-809, 2017 03.
Artículo en Inglés | MEDLINE | ID: mdl-28028555

RESUMEN

This study demonstrates real-world effectiveness of teriparatide in reducing the risk of hip and other fragility fractures. Fracture incidence significantly decreased as adherence and persistence increased for any clinical, vertebral, nonvertebral, and hip fractures among patients who were observed for 2 years after teriparatide initiation. INTRODUCTION: Examine the relationship of treatment adherence and persistence to teriparatide with hip and other fractures. METHODS: Truven MarketScan Research Databases, 2004 through 2014, provided teriparatide users ≥18 years old with continuous coverage 12 months pre- and 24 months post-teriparatide prescription. Adherence (medication possession ratio, MPR) groups were defined as high (≥0.80), medium (0.50 ≤ MPR < 0.80), and low (<0.50). Persistence, allowing for ≤90-day gaps between prescriptions, was defined as 1-6, 7-12, 13-18, and 19-24 months. Fracture incidence was summarized and compared by using ANOVA and logistic regression models; the effects of adherence were examined with Cox proportional hazard models with time-dependent covariates for teriparatide exposure. RESULTS: Among 14,284 teriparatide subjects, mean age was 68.4 years, 89.8% were female, and 29.6% had a fracture in the previous year; these characteristics were similar across MPR and persistence groups. The effects of adherence and persistence to teriparatide were statistically significant (P < .001) for all fracture types except wrist (P ≥ .125). By logistic regression, high vs low adherence was associated with reduced risk for any (OR = 0.67; P < .001); vertebral (OR = 0.64; P < .001); nonvertebral (OR = 0.71; P < .001); and hip fractures (OR = 0.52; P < .001) and longer (19-24 months) vs shorter persistence (1-6 months) was associated with reduced risk for any (OR = 0.63, P < .001); vertebral (OR = 0.56, P < .001); nonvertebral (OR = 0.69, P < .001); and hip fractures (OR = 0.48, P < .001). Cox models revealed a significantly reduced risk between high and low adherence for any (OR = 0.69, P < .001); vertebral (OR = 0.60, P < .001); nonvertebral (OR = 0.77, P < .001); and hip fractures (OR = 0.55, P < .001). CONCLUSION: Fracture incidence significantly decreased as persistence and adherence to teriparatide increased.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Osteoporosis/tratamiento farmacológico , Fracturas Osteoporóticas/prevención & control , Teriparatido/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Conservadores de la Densidad Ósea/administración & dosificación , Bases de Datos Factuales , Femenino , Fracturas de Cadera/epidemiología , Fracturas de Cadera/prevención & control , Humanos , Incidencia , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Osteoporosis/epidemiología , Fracturas Osteoporóticas/epidemiología , Medición de Riesgo/métodos , Fracturas de la Columna Vertebral/epidemiología , Fracturas de la Columna Vertebral/prevención & control , Teriparatido/administración & dosificación , Estados Unidos/epidemiología , Adulto Joven
20.
Osteoporos Int ; 27(9): 2855-2865, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27172935

RESUMEN

UNLABELLED: Medication persistence and adherence are critical for osteoporosis outcomes. Using the Taiwan National Health Insurance Research Database, we found that persistence and adherence to teriparatide were low in Taiwanese patients with osteoporosis and that greater persistence and adherence were associated with a lower incidence of hip and other nonvertebral fractures. INTRODUCTION: The purpose of this study was to determine the persistence and adherence to teriparatide treatment in Taiwanese patients with osteoporosis, and to examine the association between persistence and adherence to teriparatide with fracture risks. METHODS: Medical and pharmacy claims for 4,692 patients with vertebral or hip fractures and teriparatide prescriptions between 2005 and 2008 were identified (Taiwan National Health Insurance Research Database). Persistence was the time from the start of treatment to the first 90-day gap between two teriparatide prescriptions. Adherence was the number of teriparatide pens (each pen is used over 1 month) prescribed over 24 months. Association of persistence and adherence to teriparatide with fracture incidence was assessed using adjusted Cox proportional hazards models. RESULTS: The proportion of patients persisting with teriparatide for >6 months and >12 months was 44.6 and 24.9 %, respectively. Over 24 months, 53.6 % of patients were adherent for >6 months and 33.9 % were adherent for >12 months. Patients persisting for >12 months had a significantly lower incidence of hip (adjusted hazard ratio [HR], 0.61 [95 % confidence interval (CI), 0.40-0.93], P = 0.0229) and nonvertebral fracture (HR, 0.79 [95 % CI, 0.63-0.99], P = 0.0462) compared with those who persisted for ≤12 months. Patients adherent for >12 months had a lower incidence of hip (HR, 0.66 [95 % CI, 0.46-0.96], P = 0.0286) and nonvertebral fracture (HR, 0.81 [95 % CI, 0.66-0.99], P = 0.0377) compared with those adherent for ≤12 months. CONCLUSIONS: Persistence and adherence to teriparatide over 24 months were low in Taiwanese patients with osteoporosis; greater adherence and persistence were associated with a lower incidence of nonvertebral fractures.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Fracturas Óseas/epidemiología , Cumplimiento de la Medicación , Teriparatido/uso terapéutico , Anciano , Anciano de 80 o más Años , Femenino , Fracturas Óseas/prevención & control , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Programas Nacionales de Salud , Taiwán/epidemiología
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