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1.
J Am Acad Dermatol ; 90(3): 521-529, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37871805

RESUMO

BACKGROUND: Janus kinase 1 inhibition may alleviate hidradenitis suppurativa (HS)-associated inflammation and improve symptoms. OBJECTIVE: To assess efficacy and safety of povorcitinib (selective oral Janus kinase 1 inhibitor) in HS. METHODS: This placebo-controlled phase 2 study randomized patients with HS 1:1:1:1 to receive povorcitinib 15, 45, or 75 mg or placebo for 16 weeks. Primary and key secondary end points were mean change from baseline in abscess and inflammatory nodule count and percentage of patients achieving HS Clinical Response at week 16. RESULTS: Of 209 patients randomized (15 mg, n = 52; 45 mg, n = 52; 75 mg, n = 53; placebo, n = 52), 83.3% completed the 16-week treatment. At week 16, povorcitinib significantly reduced abscess and inflammatory nodule count from baseline (least squares mean [SE] change: 15 mg, -5.2 [0.9], P = .0277; 45 mg, -6.9 [0.9], P = .0006; 75 mg, -6.3 [0.9], P = .0021) versus placebo (-2.5 [0.9]). More povorcitinib-treated patients achieved HS Clinical Response at week 16 (15 mg, 48.1%, P = .0445; 45 mg, 44.2%, P = .0998; 75 mg, 45.3%, P = .0829) versus placebo (28.8%). A total of 60.0% and 65.4% of povorcitinib- and placebo-treated patients had adverse events. LIMITATIONS: Baseline lesion counts were mildly imbalanced between groups. CONCLUSION: Povorcitinib demonstrated efficacy in HS, with no evidence of increased incidence of adverse events among doses.


Assuntos
Hidradenite Supurativa , Humanos , Hidradenite Supurativa/diagnóstico , Abscesso , Janus Quinase 1 , Resultado do Tratamento , Índice de Gravidade de Doença , Método Duplo-Cego
2.
JAMA Dermatol ; 159(11): 1258-1266, 2023 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-37755725

RESUMO

Importance: Although several clinician- and patient-reported outcome measures have been developed for trials in hidradenitis suppurativa (HS), there is currently no consensus on which measures are best suited for use in clinical practice. Identifying validated and feasible measures applicable to the practice setting has the potential to optimize treatment strategies and generate generalizable evidence that may inform treatment guidelines. Objective: To establish consensus on a core set of clinician- and patient-reported outcome measures recommended for use in clinical practice and to establish the appropriate interval within which these measures should be applied. Evidence Review: Clinician- and patient-reported HS measures and studies describing their psychometric properties were identified through literature reviews. Identified measures comprised an item reduction survey and subsequent electronic Delphi (e-Delphi) consensus rounds. In each consensus round, a summary of outcome measure components and scoring methods was provided to participants. Experts were provided with feasibility characteristics of clinician measures to aid selection. Consensus was achieved if at least 67% of respondents agreed with use of a measure in clinical practice. Findings: Among HS experts, response rates for item reduction, e-Delphi round 1, and e-Delphi round 2 surveys were 76.4% (42 of 55), 90.5% (38 of 42), and 92.9% (39 of 42), respectively; among patient research partners (PRPs), response rates were 70.8% (17 of 24), 100% (17 of 17), and 82.4% (14 of 17), respectively. The majority of experts across rounds were practicing dermatologists with 18 to 19 years of clinical experience. In the final e-Delphi round, most PRPs were female (12 [85.7%] vs 2 males [11.8%]) and aged 30 to 49 years. In the final e-Delphi round, HS experts and PRPs agreed with the use of the HS Investigator Global Assessment (28 [71.8%]) and HS Quality of Life score (13 [92.9%]), respectively. The most expert-preferred assessment interval in which to apply these measures was 3 months (27 [69.2%]). Conclusions and Relevance: An international group of HS experts and PRPs achieved consensus on a core set of HS measures suitable for use in clinical practice. Consistent use of these measures may lead to more accurate assessments of HS disease activity and life outcomes, facilitating shared treatment decision-making in the practice setting.


Assuntos
Hidradenite Supurativa , Feminino , Humanos , Masculino , Consenso , Técnica Delphi , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/terapia , Avaliação de Resultados em Cuidados de Saúde , Medidas de Resultados Relatados pelo Paciente , Qualidade de Vida , Adulto , Pessoa de Meia-Idade
3.
J Dermatolog Treat ; 34(1): 2247105, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-37587862

RESUMO

BACKGROUND: Non-immunosuppressed patients with a history of multiple non-melanoma skin cancers (NMSCs) taking oral nicotinamide supplementation experienced a 23% decrease in annual NMSC risk in a randomized clinical trial. Patient preferences for risks and costs associated with nicotinamide are unknown. OBJECTIVES: To understand how patients prioritize NMSC reduction, infection risk, and cost. METHODS: A sample of adults with history of ≥2 NMSC within the past five years undergoing Mohs procedure completed a discrete-choice experiment comprising two hypothetical treatments-characterized by varying reductions in NMSC incidence, increased severe infection risk, and cost-and no treatment. The data were analyzed with random-parameters logit models. RESULTS: A total of 203 subjects (mean age 71.5 years, 65.5% males) participated. For a 23% annual reduction in NMSC incidence, a 26% [95% CI: 8%-45%] annual increase in severe infection risk and $8 [95% CI: $2-14] monthly cost was acceptable. Outcomes across analyzed subgroups (before vs. during COVID pandemic, site of interview, less vs. more prior NMSCs) were similar. CONCLUSIONS: Patients were unwilling to accept high severe infection risks to obtain the reduction in NMSC incidence observed in a nicotinamide trial, suggesting that routinely recommending nicotinamide may run counter to some patients' preferences.


Assuntos
COVID-19 , Neoplasias Cutâneas , Adulto , Masculino , Humanos , Idoso , Feminino , Modelos Logísticos , Niacinamida/efeitos adversos , Pandemias , Neoplasias Cutâneas/epidemiologia , Neoplasias Cutâneas/prevenção & controle
5.
J Emerg Med ; 63(5): 636-644, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36243614

RESUMO

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic immune-mediated inflammatory skin disease characterized by abscesses and inflammatory nodules, and occasionally tunnels and scars, in the axillae, groin, and inframammary areas. OBJECTIVE: HS can be challenging to diagnose because it mimics localized soft-tissue infection. The process of differentiating HS from soft-tissue infection is discussed. Patients with HS frequently visit emergency departments (EDs) for acute management of pain and drainage from HS lesions. This review updates emergency and urgent care physicians on how to educate and initiate treatment for patients with HS, and to coordinate care with dermatologists and other physicians early in their disease course. DISCUSSION: Recent updates on the epidemiology, diagnosis, and management of HS are reviewed. CONCLUSIONS: Practice variations between how care for HS is provided in the ED setting and what HS treatment guidelines recommend are identified.


Assuntos
Hidradenite Supurativa , Humanos , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/terapia , Hidradenite Supurativa/epidemiologia , Serviço Hospitalar de Emergência , Abscesso/complicações , Axila , Drenagem
6.
Value Health ; 25(9): 1582-1589, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35623975

RESUMO

OBJECTIVES: This study aimed to assess the content validity and reliability of the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) by rheumatologists treating patients with psoriatic arthritis. METHODS: There were 3 stages of analyses with 3 clinician cohort groups. Stage 1 (concept confirmation) included rheumatologist qualitative data (cohort 1) to establish content validity, acceptability, utility, and feasibility of the PGA-F in assessing nail severity. Quantitative information regarding the response category utilization in nail abnormalities was assessed by photographs. Stage 2 (inter-rater reliability) involved quantitative analysis of PGA-F data from study investigators, including rheumatologists, involved in a phase III clinical study (cohort 2) and a cohort of newly recruited rheumatologists (cohort 3). Stage 3 included known-groups validity. RESULTS: Qualitative analyses identified consensus that the PGA-F severity levels are comprehensive of real-world patient symptoms and the instrument is simple to use and understand. Psychometric analyses support the PGA-F as a clinical outcome assessment tool. Inter-rater reliability showed rheumatologist agreement across the fingernail psoriasis severity spectrum. They were monotonically ordered by the hypothesized severity structure with excellent fit to the clinicians who evaluated them. Agreement on the rank order of the severity of the photographs in this target rheumatologist population was consistent with previous reports by dermatologists. CONCLUSIONS: The PGA-F was shown to be usable by rheumatologists to measure patients along the full range of the fingernail psoriasis severity spectrum, have a strong relationship with a conceptually similar reference measure, differentiate among patients based on fingernail psoriasis severity, and detect category severity change over a 24-week period.


Assuntos
Artrite Psoriásica , Psoríase , Humanos , Artrite Psoriásica/diagnóstico , Unhas , Psoríase/tratamento farmacológico , Psoríase/terapia , Reprodutibilidade dos Testes , Reumatologistas , Índice de Gravidade de Doença
7.
Pediatr Ann ; 51(3): e123-e127, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35293815

RESUMO

Hidradenitis suppurativa (HS) is a debilitating chronic inflammatory skin disease that presents as exquisitely tender abscesses, draining fistulae, and sinus tracts. HS can lead to significant impairments in patients' quality of life, especially for children and adolescents who face challenges related to self-esteem and physical and emotional development. Severe long-term physical sequelae of inadequately treated HS include extensive scarring, urogenital strictures, immobility, and squamous cell carcinoma; emotional sequelae include depression, anxiety, and suicidal ideation. Many of the devastating long-term sequelae associated with HS can be prevented with early recognition and proper collaborative management. This article reviews strategies to aid pediatricians in early diagnosis of HS and provides clinical pearls for management and prevention of disease flares. [Pediatr Ann. 2022;51(3):e123-e127.].


Assuntos
Carcinoma de Células Escamosas , Hidradenite Supurativa , Pediatria , Adolescente , Criança , Hidradenite Supurativa/complicações , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/terapia , Humanos , Inflamação , Qualidade de Vida
8.
Br J Dermatol ; 187(3): 288-294, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35104363

RESUMO

Cutaneous damage caused by hidradenitis suppurativa (HS) is an important contributor to disease burden, independent of active lesions. Outcome measures used to specifically assess damage are becoming commonplace in the assessment of inflammatory diseases. However, no standardized method for assessing HS damage currently exists. The purpose of this study was to review outcome measures in HS that include constructs of both active disease and damage, review damage-specific instruments used in other inflammatory and destructive diseases, and review instruments used to assess scars of various aetiologies. This ultimately provides insight into how attributes of different tools can be applied to develop an outcome measure specific to HS damage. What is already known about this topic? Hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin condition, which causes consequent cutaneous damage and scarring. Damage caused by HS is highly prevalent and an important contributor to its morbidity. Damage is an important component of inflammatory diseases that has proven its utility in a number of outcome measures; however, no standardized method for assessing HS damage currently exists. What does this study add? This narrative review assesses outcome measures used to measure damage in other inflammatory and destructive diseases. Instruments used to assess damage in other diseases can provide a starting point for the development of a damage outcome measure for HS.


Assuntos
Hidradenite Supurativa , Cicatriz , Hidradenite Supurativa/diagnóstico , Hidradenite Supurativa/terapia , Humanos , Avaliação de Resultados em Cuidados de Saúde , Recidiva
9.
Obstet Gynecol ; 137(4): 731-746, 2021 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-33706337

RESUMO

Hidradenitis suppurativa is a chronic immune-mediated inflammatory skin disease with a prevalence of 0.1-1%, characterized by nodules and abscesses in the axillae, groin, and inframammary areas, sometimes developing into tunnels (or fistulas) and scars. Because hidradenitis suppurativa is more common in women and in those aged 18-40 years, obstetrician-gynecologists (ob-gyns) have the opportunity to diagnose, educate, initiate treatment, and coordinate care with ancillary health care professionals. The recently published North American treatment guidelines, along with management information for patients with hidradenitis suppurativa who are pregnant or breastfeeding, are summarized. By diagnosing and optimizing hidradenitis suppurativa treatment early in the disease course, ob-gyns can reduce morbidity, with the potential to favorably alter disease trajectory.


Assuntos
Hidradenite Supurativa/epidemiologia , Complicações na Gravidez/epidemiologia , Cuidado Pré-Natal , Adolescente , Adulto , Feminino , Ginecologia , Hidradenite Supurativa/etiologia , Hidradenite Supurativa/terapia , Humanos , Obstetrícia , Gravidez , Complicações na Gravidez/etiologia , Complicações na Gravidez/terapia , Prevalência , Estados Unidos/epidemiologia , Adulto Jovem
10.
Am J Obstet Gynecol ; 224(1): 54-61, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-32980357

RESUMO

Hidradenitis suppurativa is a chronic inflammatory disease that disproportionately affects women of childbearing age. Hidradenitis suppurativa is characterized by painful nodules, abscesses, draining dermal tunnels, and scarring with a predilection for intertriginous sites, such as the axilla, groin, and breast regions. Delay in diagnosis and treatment of hidradenitis suppurativa often results in long-term sequelae leading to significant morbidity, and rarely mortality, in these patients. This clinical opinion suggests that obstetrician-gynecologists are uniquely poised to recognize early signs of hidradenitis suppurativa during routine well-woman examinations and initiate treatment or referral to dermatology. Herein, we provide clinical pearls for obstetrician-gynecologists caring for female patients with hidradenitis suppurativa, including strategies for comprehensive management and recommendations to improve the comfort of patients with hidradenitis suppurativa during examinations.


Assuntos
Hidradenite Supurativa/diagnóstico , Axila , Mama , Árvores de Decisões , Feminino , Virilha , Hidradenite Supurativa/tratamento farmacológico , Humanos , Saúde da Mulher
11.
Exp Dermatol ; 29(12): 1154-1170, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33058306

RESUMO

The 14 authors of the first review article on hidradenitis suppurativa (HS) pathogenesis published 2008 in EXPERIMENTAL DERMATOLOGY cumulating from the 1st International Hidradenitis Suppurativa Research Symposium held March 30-April 2, 2006 in Dessau, Germany with 33 participants were prophetic when they wrote "Hopefully, this heralds a welcome new tradition: to get to the molecular heart of HS pathogenesis, which can only be achieved by a renaissance of solid basic HS research, as the key to developing more effective HS therapy." (Kurzen et al. What causes hidradenitis suppurativa? Exp Dermatol 2008;17:455). Fifteen years later, there is no doubt that the desired renaissance of solid basic HS research is progressing with rapid steps and that HS has developed deep roots among inflammatory diseases in Dermatology and beyond, recognized as "the only inflammatory skin disease than can be healed". This anniversary article of 43 research-performing authors from all around the globe in the official journal of the European Hidradenitis Suppurativa Foundation e.V. (EHSF e.V.) and the Hidradenitis Suppurativa Foundation, Inc (HSF USA) summarizes the evidence of the intense HS clinical and experimental research during the last 15 years in all aspects of the disease and provides information of the developments to come in the near future.


Assuntos
Hidradenite Supurativa/etiologia , Autoimunidade , Linfócitos B , Infecções Bacterianas/complicações , Complemento C5a/metabolismo , Citocinas/metabolismo , Genótipo , Hidradenite Supurativa/tratamento farmacológico , Hidradenite Supurativa/etnologia , Hidradenite Supurativa/metabolismo , Humanos , Mutação , Dor/etiologia , Fenótipo , Prurido/etiologia , Fatores de Risco , Pele/microbiologia , Fumar/efeitos adversos , Linfócitos T , Transcriptoma
12.
J Am Acad Dermatol ; 80(1): 60-69.e2, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29860040

RESUMO

BACKGROUND: The optimal long-term dosing strategy for adalimumab (ADA) in hidradenitis suppurativa/acne inversa (HS) was evaluated by pooling the results of the PIONEER phase 3 trials and an open-label extension (OLE) study. OBJECTIVE: To assess the response to and tolerability of long-term administration of ADA in HS. METHODS: The durations of the PIONEER I/II periods A, B, and OLE were 12, 24, and 52 or more weeks, respectively. Patients who entered the OLE and received ADA (40 mg every week continuously) and responders plus partial responders (PRRs) were evaluated. Primary efficacy assessments included measurement of HS clinical response (HiSCR), lesion counts, skin pain, and Dermatology Life Quality Index (DLQI). Treatment-emergent adverse events were assessed. RESULTS: At week 12, 52.3% of those receiving ADA weekly and 73.0% of PRRs achieved HiSCR. Achievement of HiSCR was maintained through week 168 in 52.3% of patients who received ADA weekly and 57.1% of PRRs. Sustained improvement in lesion counts, skin pain, and DLQI score were also observed. The safety profile throughout the OLE was similar to the profiles observed in the PIONEER studies. LIMITATIONS: The OLE was uncontrolled. CONCLUSION: Continuous weekly dosing with ADA, 40 mg, is a reasonable treatment option for long-term control of moderate-to-severe HS.


Assuntos
Adalimumab/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Hidradenite Supurativa/tratamento farmacológico , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
13.
Acta Derm Venereol ; 98(10): 932-937, 2018 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-30085324

RESUMO

Hidradenitis Suppurativa Clinical Response (HiSCR), is a validated tool that has been used to assess the efficacy of adalimumab among patients with hidradenitis suppurativa. We evaluated the clinical meaning of HiSCR by relating it to patient-reported outcomes to give further context to its achievement in a post hoc analysis of integrated data from two phase 3 clinical trials (PIONEER I and II). Pooling placebo and active treatment arms, 39% of patients (245/629) achieved HiSCR at week 12. Irrespective of treatment, significantly (p <0.05) more HiSCR responders than non-responders experienced clinically meaningful improvement in Dermatology Life Quality Index (60.5% vs 30.4%), Pain Numeric Rating Scale (46.9% vs 19.9%), hidradenitis suppurativa quality of life (49.4% vs 26.9%), work-related performance (52.6% vs 37.7%), and non-work-related performance (59.5% vs 33.3%). Clinically meaningful outcomes in hidradenitis suppurativa are more likely to be attained in patients achieving HiSCR level improvement.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Hidradenite Supurativa/tratamento farmacológico , Qualidade de Vida , Absenteísmo , Adulto , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Presenteísmo , Índice de Gravidade de Doença , Desempenho Profissional
15.
J Am Acad Dermatol ; 78(1): 90-99.e1, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28993005

RESUMO

BACKGROUND: Previous clinical trials have not evaluated improvement in nail psoriasis as a primary end point. OBJECTIVE: This phase 3 trial evaluated the safety and efficacy of adalimumab in patients with moderate-to-severe fingernail psoriasis and moderate-to-severe plaque psoriasis. METHODS: Patients were randomized 1:1 to 40 mg adalimumab every other week or placebo. The primary efficacy end point was at least 75% improvement in total-fingernail modified Nail Psoriasis Severity Index (NAPSI75) response rate at week 26. Ranked secondary end point scores evaluated at week 26 were total-fingernail NAPSI and modified NAPSI, nail pain, Nail Psoriasis Physical Functioning Severity, Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index, and Physician's Global Assessment (fingernail psoriasis). RESULTS: Of the 217 randomized patients (108 received placebo and 109 received adalimumab), 188 (86.6%) completed 26 weeks of treatment (period A) or escaped early to the open-label period. The study met the primary end point (response rate of 3.4% with placebo vs 46.6% with adalimumab [P < .001]) and all ranked secondary end points. The serious adverse event rates (placebo vs adalimumab) in period A were 4.6% versus 7.3%; the serious infections rates were 1.9% versus 3.7%. LIMITATIONS: Patients with less than 5% BSA involvement were not eligible for enrollment. CONCLUSIONS: After 26 weeks of adalimumab treatment, significant improvements were seen in the primary and all ranked secondary end points and in signs and symptoms of moderate-to-severe nail psoriasis versus with placebo and no new safety risks were identified.


Assuntos
Adalimumab/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Doenças da Unha/tratamento farmacológico , Psoríase/tratamento farmacológico , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais Humanizados/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Humanos , Injeções Subcutâneas , Masculino , Dose Máxima Tolerável , Pessoa de Meia-Idade , Doenças da Unha/etiologia , Doenças da Unha/fisiopatologia , Segurança do Paciente , Psoríase/complicações , Psoríase/diagnóstico , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Resultado do Tratamento
16.
J Am Acad Dermatol ; 77(6): 1030-1037, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28993007

RESUMO

BACKGROUND: Most methotrexate-treated psoriasis patients do not achieve a long-term PASI75 (75% reduction from baseline Psoriasis Area and Severity Index score) response. Indications of nonresponse can be apparent after only 4 weeks of treatment. OBJECTIVE: To develop a prediction rule to identify patients unlikely to respond adequately to methotrexate. METHODS: Patient-level data from CHAMPION (NCT00235820, N = 110) was used to construct a prediction model for week 16 PASI75 by using patient baseline characteristics and week 4 PASI25. A prediction rule was determined on the basis of the sensitivity and specificity and validated in terms of week 16 PASI75 response in an independent validation sample from trial M10-255 (NCT00679731, N = 163). RESULTS: PASI25 achievement at week 4 (odds ratio = 8.917) was highly predictive of response with methotrexate at week 16. Patients with a predicted response probability <30% were recommended to discontinue methotrexate. The rates of week 16 PASI75 response were 65.8% and 21.1% (P < .001) for patients recommended to continue and discontinue methotrexate, respectively. LIMITATIONS: The CHAMPION trial excluded patients previously treated with biologics, and the M10-255 trial had no restrictions. CONCLUSION: A prediction rule was developed and validated to identify patients unlikely to respond adequately to methotrexate. The rule indicates that 4 weeks of methotrexate might be sufficient to predict long-term response with limited safety risk.


Assuntos
Fármacos Dermatológicos/uso terapêutico , Metotrexato/uso terapêutico , Psoríase/tratamento farmacológico , Adulto , Feminino , Humanos , Masculino , Modelos Estatísticos , Prognóstico , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
17.
J Am Acad Dermatol ; 77(6): 1038-1046, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28917381

RESUMO

BACKGROUND: Psoriasis and hidradenitis suppurativa (HS) exhibit distinct clinical features, but no studies have directly compared the health-related quality of life (HRQoL) in patients with moderate-to-severe manifestations of these conditions. OBJECTIVE: To determine which disease is associated with more severe HRQoL impairment. METHODS: Weighted averages of each of the following baseline HRQoL measures were determined and compared between HS and psoriasis populations from 5 clinical trials: Visual Analog Scale (VAS) for pain, Total Work Productivity Impairment, Dermatology Life Quality Index; EuroQOL 5D VAS, and Short Form-36 Health Survey. RESULTS: Compared with patients with psoriasis, patients with HS reported higher scores for VAS-pain (54.3 vs 36.1 [P < .0001]), Dermatology Life Quality Index (15.3 vs 11.3 [P < .0001]), EuroQOL 5D VAS (58.8 vs 50.8 [P < .0002]), and Total Work Productivity Impairment (35.4 vs 18.2). Patients with HS had lower Short Form-36 Health Survey scores than did patients with psoriasis (physical, 39.6 vs 49.0; mental, 41.5 vs 47.5 [both P < .0001]). LIMITATIONS: This analysis was performed using published summary data rather than patient-level data, and weighted pooled averages were compared. CONCLUSIONS: Patients with HS have a higher HRQoL burden than patients with psoriasis. This study clearly documents the needs of patients with HS and the potential impact of medical, scientific, and societal consensus for the development of more effective HS treatments.


Assuntos
Hidradenite Supurativa , Psoríase , Qualidade de Vida , Adulto , Efeitos Psicossociais da Doença , Feminino , Hidradenite Supurativa/diagnóstico , Humanos , Masculino , Psoríase/diagnóstico , Índice de Gravidade de Doença
18.
N Engl J Med ; 375(5): 422-34, 2016 Aug 04.
Artigo em Inglês | MEDLINE | ID: mdl-27518661

RESUMO

BACKGROUND: Hidradenitis suppurativa is a painful, chronic inflammatory skin disease with few options for effective treatment. In a phase 2 trial, adalimumab, an antibody against tumor necrosis factor α, showed efficacy against hidradenitis suppurativa. METHODS: PIONEER I and II were similarly designed, phase 3 multicenter trials of adalimumab for hidradenitis suppurativa, with two double-blind, placebo-controlled periods. In period 1, patients were randomly assigned in a 1:1 ratio to 40 mg of adalimumab weekly or matching placebo for 12 weeks. In period 2, patients were reassigned to adalimumab at a weekly or every-other-week dose or to placebo for 24 weeks. The primary end point was a clinical response, defined as at least a 50% reduction from baseline in the abscess and inflammatory-nodule count, with no increase in abscess or draining-fistula counts, at week 12. RESULTS: We enrolled 307 patients in PIONEER I and 326 in PIONEER II. Clinical response rates at week 12 were significantly higher for the groups receiving adalimumab weekly than for the placebo groups: 41.8% versus 26.0% in PIONEER I (P=0.003) and 58.9% versus 27.6% in PIONEER II (P<0.001). Patients receiving adalimumab had significantly greater improvement than the placebo groups in rank-ordered secondary outcomes (lesions, pain, and the modified Sartorius score for disease severity) at week 12 in PIONEER II only. Serious adverse events in period 1 (excluding worsening of underlying disease) occurred in 1.3% of patients receiving adalimumab and 1.3% of those receiving placebo in PIONEER I and in 1.8% and 3.7% of patients, respectively, in PIONEER II. In period 2, the rates of serious adverse events were 4.6% or less in all the groups in both studies, with no significant between-group differences. CONCLUSIONS: Treatment with adalimumab (40 mg weekly), as compared with placebo, resulted in significantly higher clinical response rates in both trials at 12 weeks; rates of serious adverse events were similar in the study groups. (Funded by AbbVie; ClinicalTrials.gov numbers, NCT01468207 and NCT01468233 for PIONEER I and PIONEER II, respectively.).


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Hidradenite Supurativa/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/efeitos adversos , Adulto , Anti-Inflamatórios/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
19.
Dermatol Online J ; 22(3)2016 Mar 16.
Artigo em Inglês | MEDLINE | ID: mdl-27136622

RESUMO

BACKGROUND: Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory skin disease with frequent comorbidities of painand depression. Adalimumab treatment for 16 weeks improved HS lesions significantly versus placebo (NCT00918255). OBJECTIVE: The relationship between pain and depressive symptoms and the effects of adalimumab on each was examined in this post hoc analysis. METHODS: Patients with moderate to severe HS (N=154) were randomized 1:1:1 to adalimumab 40 mg weekly (ew), adalimumab 40 mg every other week (eow), or placebo. Skin pain was assessed using a visual analog scale (VAS; 0-100 mm). Depressive symptoms were assessed using the 9-item Patient Health Questionnaire (PHQ-9; score ≥10 indicative of depression). RESULTS: At baseline, overall mean±SD pain VAS was 54.3±26.5 mm and 41.8% of patients had PHQ-9 scores ≥10. At baseline, VAS pain scores (mean±SD) were significantly higher (P<0.001) for patients with PHQ-9 scores ≥10 (63.9±23.3) versus <10 (47.4±26.7). At Week 16, clinically relevant pain reduction was observed for ew-treated patients with baseline PHQ-9 score ≥10 (ew, 45.8%; eow, 29.4%; placebo, 23.8%) and <10 (ew, 50.0%; eow, 37.9%; placebo, 29.6%), but did not reach statistical significance. In patients with high baseline pain (≥median VAS score), adalimumab ew significantly decreased depressivesymptoms versus placebo (PHQ-9 scores, -34.03% vs +2.26%; P<0.01). CONCLUSION: Patients with moderate to severe HS had a high degree of pain and depressive symptoms at baseline. Adalimumabtherapy was associated with decreased pain and depressive symptoms compared to baseline.


Assuntos
Adalimumab/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Depressão/psicologia , Hidradenite Supurativa/tratamento farmacológico , Adulto , Método Duplo-Cego , Feminino , Hidradenite Supurativa/complicações , Hidradenite Supurativa/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Medição da Dor , Resultado do Tratamento , Adulto Jovem
20.
J Med Econ ; 19(7): 710-7, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26938967

RESUMO

Objective Hidradenitis suppurativa (HS) is often treated by surgery. The risk of recurrence after surgery is common and the consequences are substantial, but neither has been quantified using a claims database. This study aimed to estimate the burden associated with non-curative surgery in HS patients. Methods A retrospective analysis was performed of health insurance claims data from Q1 1999 to Q2 2011 in a US claims database. The analysis included 2668 adults with ≥1 diagnosis of HS and ≥1 claim for skin surgery within 6 months after diagnosis. Healthcare resource utilization and medical costs were compared using multivariate regressions. Results Overall, 46% of HS patients had ≥1 indicator of non-curative surgery. The incidences of inpatient, emergency department, and outpatient visits were 88%, 40%, and 30% higher, respectively, for patients with non-curative surgery vs patients without indicator of non-curative surgery (all p < 0.001). Average medical costs were $11,858 and $6427 for patients with and without indicators of non-curative surgery, respectively. The difference of $4185 (p < 0.001) was mainly driven by inpatient costs (difference = $2685; p < 0.001). Limitations Indicators of non-curative HS surgery were defined based on an empirical algorithm. Conclusions Non-curative HS surgery occurred in almost half of all cases and represents a significant burden on patients and payers in terms of resource utilization and costs.


Assuntos
Hidradenite Supurativa/economia , Hidradenite Supurativa/cirurgia , Adulto , Serviço Hospitalar de Emergência/economia , Serviço Hospitalar de Emergência/estatística & dados numéricos , Feminino , Gastos em Saúde , Serviços de Saúde/economia , Serviços de Saúde/estatística & dados numéricos , Humanos , Revisão da Utilização de Seguros , Masculino , Pessoa de Meia-Idade , Modelos Econométricos , Recidiva , Análise de Regressão , Estudos Retrospectivos
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