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1.
Expert Opin Drug Saf ; 19(1): 93-97, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31615274

RESUMO

Objectives: The objective of this study was to calculate adherence, persistence and 10-year switches in patients with PsA, by comparing adalimumab and etanercept in real life.Methods: The authors conducted a retrospective, observational, pharmacological and non-interventional study taking into consideration the dispensations of the study drugs at the Hospital Pharmacy, from 1 January 2007 to 31 December 2018. In the study, the authors considered adalimumab and etanercept. The authors calculated adherence to treatment through the relationship between received daily dose (RDD) and prescribed daily dose (PDD), and calculated persistence to treatment as the difference in days between the first and last dispensation.Results: The authors enrolled 113 patients, 60 treated with adalimumab and 53 with etanercept. Adherence levels were 0.83 for adalimumab and 0.84 for etanercept. Switches occurred in 42% of adalimumab and in 47% of etanercept prescriptions.Conclusion: In the treatment of PsA, persistence and switches are a problem for patients who cannot follow a consistent therapy over time, for clinicians who have to manage therapy suspension and changes, and for the National Health System that must procure and pay for a high number of drugs without information on their real value in terms of efficacy and safety of use.


Assuntos
Adalimumab/administração & dosagem , Artrite Psoriásica/tratamento farmacológico , Etanercepte/administração & dosagem , Adesão à Medicação/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antirreumáticos/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
2.
Expert Opin Drug Saf ; 18(12): 1219-1235, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31801415

RESUMO

Introduction: The treatment strategies for noninfectious uveitis (NIU) aim to achieve disease remission, prevention of recurrences, and preserving vision, while minimizing the side effects associated with the therapies used.Areas covered: The index review aims to provide a detailed overview of the adverse events and safety parameters associated with the systemic therapies for the management of the NIU.Expert opinion: Despite being the cornerstone of management of acute cases of NIU, long-term corticosteroid use is associated with multi-system side effects, requiring the use of steroid-sparing agents. Adalimumab was recently approved by the FDA for the management of NIU based on the results of VISUAL studies. Similarly, newer drugs targeting various aspects of the inflammatory cascade are being developed. However, until we completely understand the molecular pathways of the inflammatory diseases, the therapeutic profile of these newer agents needs to be broad enough to suppress inflammatory cascade and narrow enough to spare normal cellular processes. Another strategy that has shown some potential in decreasing the systemic side effects is to provide local drug delivery. Therefore, the future of management of NIU is very bright with many novel therapeutic agents and strategies of drug delivery on the horizon.


Assuntos
Sistemas de Liberação de Medicamentos , Desenvolvimento de Medicamentos , Uveíte/tratamento farmacológico , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Corticosteroides/administração & dosagem , Corticosteroides/efeitos adversos , Humanos
5.
Isr Med Assoc J ; 21(7): 475-479, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31507124

RESUMO

BACKGROUND: Uveitis is an inflammatory disorder of the uveal tract of the eye that can affect both adults and children. Non-infectious uveitis can be an expression of a systemic autoimmune condition, or it can be idiopathic. It is a serious disease, associated with possible severe complications leading to visual impairment and blindness. For this reason, a prompt diagnosis and assessment of an appropriate treatment, with the collaboration of specialists such as ophthalmologists and rheumatologists, are extremely important. Many treatment options may be associated to side effects; therefore, clinicians should follow a stepladder approach starting with the least aggressive treatments to induce remission of inflammation. In this review, we reported the current evidence-based treatments for non-infectious uveitis in pediatric and adult patients with particular attention to the biologic response modifier treatment options. Important multicenter studies have demonstrated the efficacy of adalimumab, both in adults (VISUAL I, VISUAL II, VISUAL III) and in children (SYCAMORE, ADJUVITE), while for other agents data are still scarce.


Assuntos
Adalimumab/administração & dosagem , Fatores Imunológicos/administração & dosagem , Uveíte/tratamento farmacológico , Adulto , Criança , Comportamento Cooperativo , Medicina Baseada em Evidências , Humanos , Inflamação/tratamento farmacológico , Uveíte/diagnóstico , Uveíte/patologia
6.
Pharm Res ; 36(11): 157, 2019 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-31493066

RESUMO

PURPOSE: Although pharmacokinetic (PK) interaction effects of methotrexate (MTX) on adalimumab have been found, the mechanism of these effects is still unclear. In this work, effects of MTX on the concentration of neonatal Fc receptor (FcRn) and the role of FcRn in the interaction between MTX and adalimumab were investigated. METHODS: The experiment was performed in rats whose FcRn had normal physiological function and also in rats whose FcRn was blocked with FcRn antibody. Rats were randomly assigned to receive placebo or 0.2 mg/kg MTX orally every week while taking one abdominal subcutaneous injection of 0.5 mg/kg adalimumab. The FcRn concentration in tissues and the PK parameters of adalimumab were compared between MTX-treated and placebo groups. RESULTS: In rats with normally functioning FcRn, the concentrations of FcRn were significantly increased in the liver (F=105.5, p=0.000) and kidney (F=996.312, p=0.000) after treatment with MTX, and the clearance (CL/F) of adalimumab was decreased accordingly (F=4.423, p=0.048). However, in rats injected with FcRn antibody, the concentrations of FcRn in MTX-treated rats were close to that of the placebo rats in the tissues of the liver (F=1.279, p=0.268) and kidney (F=0.661, p=0.424). The CL/F of adalimumab in rats was also not affected by MTX (F=0.002, p=0.961). CONCLUSIONS: FcRn may play a vital role in the interaction between adalimumab and MTX.


Assuntos
Adalimumab/farmacocinética , Antígenos de Histocompatibilidade Classe I/metabolismo , Metotrexato/metabolismo , Receptores Fc/metabolismo , Adalimumab/administração & dosagem , Animais , Feminino , Humanos , Injeções Subcutâneas , Rim/metabolismo , Fígado/metabolismo , Masculino , Metotrexato/administração & dosagem , Metotrexato/farmacologia , Ratos Sprague-Dawley
8.
Lancet ; 394(10198): 576-586, 2019 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-31280967

RESUMO

BACKGROUND: Psoriasis is an autoimmune disease that affects approximately 100 million people worldwide, and is a disease that can be ameliorated by anti-cytokine treatment. We aimed to compare the efficacy and safety of risankizumab with adalimumab in patients with moderate-to-severe plaque psoriasis. METHODS: IMMvent was a phase 3, randomised, double-blind, active-comparator-controlled trial completed at 66 clinics in 11 countries. Eligible patients were aged 18 years or older with moderate-to-severe chronic plaque psoriasis. Patients were randomly assigned 1:1 using interactive response technology to receive 150 mg risankizumab subcutaneously at weeks 0 and 4 or 80 mg adalimumab subcutaneously at randomisation, then 40 mg at weeks 1, 3, 5, and every other week thereafter during a 16-week double-blind treatment period (part A). For weeks 16-44 (part B), adalimumab intermediate responders were re-randomised 1:1 to continue 40 mg adalimumab or switch to 150 mg risankizumab. In part A, participants and investigators were masked to study treatment. Randomisation was stratified by weight and previous tumour necrosis factor inhibitor exposure. Co-primary endpoints in part A were a 90% improvement from baseline (PASI 90) and a static Physician's Global Assessment (sPGA) score of 0 or 1 at week 16, and for part B was PASI 90 at week 44 (non-responder imputation). Efficacy analyses were done in the intention-to-treat population and safety analyses were done in the safety population (all patients who received at least one dose of study drug or placebo). This study is registered with ClinicalTrials.gov, number NCT02694523. FINDINGS: Between March 31, 2016, and Aug 24, 2017, 605 patients were randomly assigned to receive either risankizumab (n=301, 50%) or adalimumab (n=304, 50%). 294 (98%) of patients in the risankizumab group and 291 (96%) in the adalimumab group completed part A, and 51 (96%) of 53 patients re-randomised to risankizumab and 51 (91%) of 56 patients re-randomised to continue adalimumab completed part B. At week 16, PASI 90 was achieved in 218 (72%) of 301 patients given risankizumab and 144 (47%) of 304 patients given adalimumab (adjusted absolute difference 24·9% [95% CI 17·5-32·4]; p<0·0001), and sPGA scores of 0 or 1 were achieved in 252 (84%) patients given risankizumab and 252 (60%) patients given adalimumab (adjusted absolute difference 23·3% [16·6-30·1]; p<0·0001). In part B, among adalimumab intermediate responders, PASI 90 was achieved by 35 (66%) of 53 patients switched to risankizumab and 12 (21%) of 56 patients continuing adalimumab (adjusted absolute difference 45·0% [28·9-61·1]; p<0·0001) at week 44. Adverse events were reported in 168 (56%) of 301 patients given risankizumab and 179 (57%) of 304 patients given adalimumab in part A, and among adalimumab intermediate responders, adverse events were reported in 40 (75%) of 53 patients who switched to risankizumab and 37 (66%) of 56 patients who continued adalimumab in part B. INTERPRETATION: Risankizumab showed significantly greater efficacy than adalimumab in providing skin clearance in patients with moderate-to-severe plaque psoriasis. No additional safety concerns were identified for patients who switched from adalimumab to risankizumab. Treatment with risankizumab provides flexibility in the long-term treatment of psoriasis. FUNDING: AbbVie and Boehringer Ingelheim.


Assuntos
Adalimumab/administração & dosagem , Anticorpos Monoclonais/administração & dosagem , Psoríase/tratamento farmacológico , Adalimumab/efeitos adversos , Adulto , Anticorpos Monoclonais/efeitos adversos , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade
9.
J Dermatol ; 46(9): 745-751, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31282051

RESUMO

Hidradenitis suppurativa (HS) is a chronic skin disease characterized by recurrent painful inflamed nodules/abscesses and draining fistulas that negatively impact quality of life. Adalimumab, a monoclonal antibody against tumor necrosis factor-α, has been approved in the EU, USA and Japan for the treatment of moderate to severe HS. This is an interim analysis of an ongoing phase 3, multicenter, open-label, single-arm study of the safety and efficacy of adalimumab weekly dosing in Japanese patients with moderate to severe HS. Fifteen patients received adalimumab 160 mg at week 0, 80 mg at week 2 and 40 mg every week thereafter starting at week 4. The fulfillment of Hidradenitis Suppurativa Clinical Response was assessed under adalimumab treatment; clinical response was assessed by skin pain, total abscess and inflammatory nodule count and modified Sartorius score; and quality of life and safety were assessed. At week 12, 86.7% of patients achieved clinical response, with improvements at week 12 across the primary and secondary end points generally sustained through week 24. Adalimumab weekly dosing was generally safe and well tolerated with no new safety findings through week 24. These results suggest that adalimumab is effective and well tolerated in Japanese patients with moderate to severe HS.


Assuntos
Adalimumab/administração & dosagem , Hidradenite Supurativa/tratamento farmacológico , Dor/tratamento farmacológico , Adalimumab/efeitos adversos , Adulto , Relação Dose-Resposta a Droga , Esquema de Medicação , Feminino , Hidradenite Supurativa/complicações , Hidradenite Supurativa/diagnóstico , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Dor/diagnóstico , Dor/etiologia , Medição da Dor , Satisfação Pessoal , Qualidade de Vida , Índice de Gravidade de Doença , Inquéritos e Questionários/estatística & dados numéricos , Resultado do Tratamento
10.
Expert Rev Gastroenterol Hepatol ; 13(8): 731-738, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31322440

RESUMO

Introduction: The purpose of this review is to highlight the role of biosimilars in early treatment in IBD and introduce ways to facilitate a patient-centric switching process through multidisciplinary approach. Areas covered: We summarize existing scientific literature related to the role of biosimilars in inflammatory bowel disease in terms of early treatment and cost-saving and implementing switching process. Expert opinion: Use of anti-TNF biosimilars in patients has the potential for large drug-acquisition cost-saving, which can be reinvested into early treatment. Managed switched programs for adalimumab can add further benefits in the future.


Assuntos
Anti-Inflamatórios/uso terapêutico , Medicamentos Biossimilares/uso terapêutico , Doença de Crohn/terapia , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adalimumab/administração & dosagem , Adalimumab/uso terapêutico , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/economia , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/uso terapêutico , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Doença de Crohn/diagnóstico , Doença de Crohn/economia , Doença de Crohn/enfermagem , Custos de Medicamentos , Monitoramento de Medicamentos/economia , Monitoramento de Medicamentos/métodos , Diagnóstico Precoce , Humanos , Doenças Inflamatórias Intestinais/economia , Doenças Inflamatórias Intestinais/enfermagem , Doenças Inflamatórias Intestinais/terapia , Equipe de Assistência ao Paciente , Assistência Centrada no Paciente/economia , Assistência Centrada no Paciente/métodos
11.
J Dermatol ; 46(9): 802-807, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31271451

RESUMO

Perifolliculitis capitis abscedens et suffodiens (PCAS) or dissecting cellulitis is a rare condition presenting deep follicular occlusions, follicular ruptures and follicular infections in the scalp area with unknown etiology, which consequently cause primary neutrophilic cicatricial alopecia by the repeated follicular inflammation. PCAS is categorized as one of the "follicular occlusion tetrad" along with hidradenitis suppurativa, acne conglobata and pilonidal cyst. In the pathogenesis of the follicular occlusion tetrad, the involvement of neutrophils and its activator tumor necrosis factor (TNF) have been discussed. Here, we report a case of PCAS that was successfully treated with adalimumab, a human anti-TNF monoclonal antibody. This is the first Asian case of PCAS that was improved by a TNF inhibitor.


Assuntos
Adalimumab/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Celulite (Flegmão)/tratamento farmacológico , Dermatoses do Couro Cabeludo/tratamento farmacológico , Dermatopatias Genéticas/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Celulite (Flegmão)/imunologia , Relação Dose-Resposta a Droga , Esquema de Medicação , Humanos , Injeções Subcutâneas , Masculino , Dermatoses do Couro Cabeludo/imunologia , Dermatopatias Genéticas/imunologia , Resultado do Tratamento , Fator de Necrose Tumoral alfa/imunologia , Adulto Jovem
13.
Expert Opin Drug Saf ; 18(8): 733-744, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31173698

RESUMO

Objectives: To examine agreement between the FDA Adverse Event Reporting System (FAERS) and observational studies in common infections for tumor necrosis factor inhibitors (TNFi's). Methods: Using MedDRA® preferred terms, all infection cases in FAERS with each TNFi were retrieved using EvidexTM. Observational studies reporting TNFi-related infections were identified from PubMed (OS-PM) and ClinicalTrials.gov (OS-CT). Infections with a reporting rate of ≥2% (based on percentage of total number of infections) from each data source were compiled. Fleiss's kappa and Cohen's kappa (κ) were calculated to determine agreement across all three sources and between each two sources. Results: A total of 163,789 FAERS infection cases, 53 OS-PM studies and 52 OS-CT studies were identified. The Fleiss' kappa that comparing all 3 data sources demonstrated lack of agreement. Significant moderate agreements were found between FAERS and OS-CT for etanercept and adalimumab, respectively (κ = 0.53, p = 0.02; κ = 0.56, p = 0.02), but no agreements (κ < 0) when comparing FAERS vs. OS-PM or OS-CT vs. OS-PM. Conclusion: For common TNFi-related infections, passive (FAERS) and active (observational studies) pharmacovigilance results are similar between FAERS vs. OS-CT for etanercept and adalimumab but dissimilar across the 3 sources. Our findings suggest incorporating both active and passive pharmacovigilance methods in post-marketing drug safety assessment.


Assuntos
Fatores Imunológicos/efeitos adversos , Farmacovigilância , Vigilância de Produtos Comercializados/métodos , Adalimumab/administração & dosagem , Adalimumab/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos , Doenças Autoimunes/tratamento farmacológico , Etanercepte/administração & dosagem , Etanercepte/efeitos adversos , Humanos , Fatores Imunológicos/administração & dosagem , Vigilância de Produtos Comercializados/estatística & dados numéricos , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Estados Unidos , United States Food and Drug Administration
14.
Pediatr Rheumatol Online J ; 17(1): 29, 2019 Jun 10.
Artigo em Inglês | MEDLINE | ID: mdl-31182107

RESUMO

BACKGROUND: Behçet's disease is a chronic inflammatory multisystem disorder that is characterised by oral and/or genital ulcerations as well as intraocular inflammation. Recurrent retinal vasoocclusive episodes and macular involvement may lead to severe loss of visual acuity. Patients may eventually become resistant to systemic corticosteroid and develop side effects; therefore, other immunosuppressive therapies are needed. Biologic agents are promising for the treatment of Behçet's disease-associated uveitis. Here, we report two cases of paediatric uveitis due to Behçet's disease that were successfully treated by early administration of adalimumab. CASE PRESENTATION: Patient 1 was an 11-year-old girl who presented with right conjunctival injection and photophobia. Patient 2 was a 14-year-old girl who presented with blurry vision in the left eye. Both patients were treated with topical treatment and prednisolone for uveitis; however, relapses occurred during the tapering of prednisolone. The patients were diagnosed with Behçet's disease, and adalimumab therapy was initiated. In both cases, the inflammation was well-controlled by adalimumab administration without local or systemic corticosteroid. CONCLUSIONS: Adalimumab is effective for treating children with Behçet's disease-associated uveitis. Control of ocular inflammation was achieved without local and systemic corticosteroid, thus preventing further complications.


Assuntos
Adalimumab/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Uveíte/tratamento farmacológico , Administração Oftálmica , Administração Tópica , Adolescente , Síndrome de Behçet/tratamento farmacológico , Criança , Quimioterapia Combinada , Feminino , Humanos , Prednisolona/administração & dosagem , Recidiva , Resultado do Tratamento , Transtornos da Visão/tratamento farmacológico , Transtornos da Visão/etiologia
15.
Drugs ; 79(10): 1053-1063, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31183768

RESUMO

The inflammatory bowel diseases commonly affect individuals during their peak reproductive years. Patients are often concerned about the impact of medical therapies on their ability to conceive, effect on the fetus, as well as the ability to breastfeed, which has led to poor medical adherence during pregnancy. However, most medications are safe, and discontinuation may lead to active disease, which is associated with adverse materno-fetal outcomes. The anti-TNF biologic therapies, infliximab and adalimumab have been extensively studied in the context of pregnancy. They are actively transferred to the placenta during the second and third trimesters; these have not been associated with an increased rate of congenital abnormalities or fetal death. The minimal amounts of drug that are transferred to breast milk are proteolyzed by the infant's digestive system with no reported short- or long-term adverse effects. There is a paucity of clinical data for the other approved anti-TNF agents or newer anti-integrin (vedolizumab) and anti-interleukin (ustekinumab) therapies used in the management of inflammatory bowel disease; however, no significant safety signals have been documented thus far. The new oral small molecule therapy, tofacitinib is teratogenic in animal models and is contra-indicated in patients attempting pregnancy. It is important that patients, as well as physicians managing patients with these conditions, be aware of the impact of these medical therapies during pregnancy.


Assuntos
Adalimumab/administração & dosagem , Anticorpos Monoclonais Humanizados/administração & dosagem , Doenças Inflamatórias Intestinais/tratamento farmacológico , Infliximab/administração & dosagem , Ustekinumab/administração & dosagem , Adalimumab/efeitos adversos , Administração Oral , Anticorpos Monoclonais Humanizados/efeitos adversos , Aleitamento Materno , Desenvolvimento Infantil/efeitos dos fármacos , Feminino , Humanos , Recém-Nascido , Infliximab/efeitos adversos , Leite Humano/química , Leite Humano/metabolismo , Gravidez , Transdução de Sinais , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Ustekinumab/efeitos adversos
16.
J Drugs Dermatol ; 18(5): 437-438, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-31141853

RESUMO

In the present single-center retrospective study, we investigated our data to evaluate the efficacy of the classic antibiotic combination (rifampicin and clindamycin) compared to adalimumab treatment in patients affected by moderate-to-severe hidradenitis suppurativa. Disease severity and quality of life were registered using the modified Sartorious score and Hidradisk, respectively. Data were collected before starting treatment (T0) and after ten weeks of therapy (T10). The Mann-Whitney test was used to calculate statistical differences between baseline and week 10. P values less than 0.05 were considered to be statistically significant. A spearman test was used to evaluate the correlation among the parameters under study. Thirty patients (20 females, 10 males; mean age, 23.73 ± 4.57) were given the antibiotics: instead of starting the treatment by combining the two antibiotics, we recommend patients to start the therapy taking only rifampicin 300 mg twice a day for 7 days, and after the first week, to add clindamycin at a dose of 300 mg twice a day. The mean modified Sartorius Score before starting treatment was 68.8 while the value at week 10 was 57.8 (P equals 0.0052). The mean Hidradisk value before starting treatment was 74,73 while the value at week 10 was 62 (P equals 0.0095). Ten patients (10/30) achieved the HiSCR. On the other hand, thirty subjects (22 females, 8 males; mean age, 26.2±7.25) were treated with subcutaneous injections of adalimumab (160 mg at baseline, 80 mg at week 2, 40 mg at week 4, and 40 mg weekly thereafter). The mean modified Sartorius Score before starting treatment was 74.93 while the value at week 10 was 39.86 (P less than 0.0001). The mean Hidradisk value before starting treatment was 77.73 while the value at week 10 decreased to 51.86 (P less than 0.0001). Eighteen patients (18/30) achieved the HiSCR. J Drugs Dermatol. 2019;18(5):437-438.


Assuntos
Adalimumab/uso terapêutico , Antibacterianos/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Clindamicina/uso terapêutico , Hidradenite Supurativa/tratamento farmacológico , Rifampina/uso terapêutico , Adalimumab/administração & dosagem , Administração Oral , Adulto , Antibacterianos/administração & dosagem , Anti-Inflamatórios/administração & dosagem , Clindamicina/administração & dosagem , Quimioterapia Combinada , Feminino , Humanos , Injeções Subcutâneas , Masculino , Qualidade de Vida , Estudos Retrospectivos , Rifampina/administração & dosagem , Índice de Gravidade de Doença , Resultado do Tratamento , Adulto Jovem
18.
J Manag Care Spec Pharm ; 25(7): 770-779, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31081461

RESUMO

BACKGROUND: The U.S. health care system is currently evolving from a volume-based care to a value-based care approach, which is in part supported by the introduction of patient support programs (PSP). For patients treated with adalimumab (ADA), the addition of a dedicated, trained nurse to the PSP (HUMIRA Complete, rolled out nationally in 2015) provides further emphasis on value-based care. OBJECTIVE: To determine the effectiveness of the HUMIRA Complete PSP, including the Nurse Ambassador component, in a real-world setting for patients receiving ADA across a broad range of approved indications (rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriasis, psoriatic arthritis, ankylosing spondylitis, uveitis, and hidradenitis suppurativa). METHODS: A longitudinal retrospective study was conducted using patient-level data from the HUMIRA Complete PSP data linked to the real-world, patient-level Symphony Health Solutions administrative claims database. Commercially insured patients were included who were aged ≥ 18 years with ≥ 2 diagnoses of an indicated disease who were biologically naive before initiating ADA or who had no claims for synthetic-targeted immune modulator therapy before their earliest ADA claim in the database between January 2015 and February 2017. The first claim had to have occurred in 2015 or later, and continuous medical and drug data coverage were required for ≥ 6 months before and ≥ 12 months after the first ADA claim and index date. PSP patients (with at least an initial and follow-up dedicated nurse call) were matched 1:1 to non-PSP patients based on pharmacy type, indication, and propensity score, estimated with covariates for age, sex, year of first ADA use, and baseline comorbidities. Adherence to ADA was compared using proportion of days covered along with discontinuation of ADA, defined as a gap in treatment greater than the previous days supply with no additional ADA claim, total costs, medical costs, and drug costs (2017 U.S. dollars) over 12 months. Baseline demographic and clinical characteristics were summarized descriptively. Differences between cohorts were assessed using t-tests for adherence and costs and log-rank tests for discontinuation. RESULTS: 2,268 patients (1,134 per group) were included. Baseline characteristics were similar between cohorts after matching. Participation in the PSP was associated with 29.3% higher ADA adherence (64.8% vs. 50.1%; P < 0.0001) and 22.0% lower ADA discontinuation rate (51.4% vs. 65.9%; P < 0.0001). Disease-related medical costs and all-cause medical costs were significantly lower by 35% ($10,162 vs. $15,511; P = 0.005) and 29.2% ($25,074 vs. $35,419; P = 0.0004), respectively, for PSP versus non-PSP patients. Total costs were also lower by 9% ($62,421 vs. $68,706; P = 0.056), and drug costs were 12.2% higher ($37,347 vs. $33,287; P = 0.0016). CONCLUSIONS: This retrospective study demonstrates that participation in the PSP augments value-based care by improving outcomes for patients with chronic diseases by helping them not only manage a complex treatment regimen but also lower annual health care costs. DISCLOSURES: Design, study conduct, and financial support for this study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the manuscript; all authors contributed to the development of the publication and maintained control over the final content. Brixner reports consulting fees from AbbVie, AstraZeneca, Becton Dickinson, Millcreek Outcomes Group, Sanofi, and UCB Pharma. Rubin reports consulting fees from AbbVie, Abgenomics, Allergan, Forward Pharma, Genentech/Roche, Janssen Pharmaceuticals, Merck & Co., Napo Pharmaceuticals, Pfizer, Shire, Takeda, and Target Pharmaceuticals and research support from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda. Mease reports grant/research support from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; consulting fees from AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, and UCB; and served on the speakers bureaus for AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, and UCB. Mittal and Ganguli are employees and stockholders of AbbVie. Liu has no financial conflict of interest. Davis is an employee of Medicus Economics, which reports payment from AbbVie to participate in this research. Fendrick reports personal fees from Merck, AstraZeneca, Trizetto, Amgen, Lilly, AbbVie, Johnson & Johnson, and Sanofi; grants from the National Pharmaceutical Council, PhRMA, the Gary and Mary West Health Foundation, the states of New York and Michigan, the Laura and John Arnold Foundation, the Robert Wood Johnson Foundation, and the Agency for Healthcare Research and Quality; and has equity in Zansors, Sempre Health, Wellth, and V-BID Health. Data from this study were presented in part at the Academy of Managed Care & Specialty Pharmacy Annual Meeting; April 25, 2018; Boston, MA.


Assuntos
Adalimumab/administração & dosagem , Antirreumáticos/administração & dosagem , Custos de Cuidados de Saúde/estatística & dados numéricos , Adesão à Medicação/estatística & dados numéricos , Adalimumab/economia , Adulto , Antirreumáticos/economia , Assistência à Saúde/economia , Custos de Medicamentos , Feminino , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Enfermeiras e Enfermeiros/organização & administração , Estudos Retrospectivos , Estados Unidos
19.
PLoS One ; 14(5): e0216746, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31145730

RESUMO

OBJECTIVES: To compare drug survival in patients with axial spondyloarthritis treated with different TNF inhibitors in standard dosage. METHODS: Patients fulfilling the Assessment in SpondyloArthritis international Society classification criteria for axial spondyloarthritis in the Swiss Clinical Quality Management cohort were included in this study if a first TNF inhibitor on standard dosage was started after recruitment and if a baseline visit was available. Drug maintenance up to drug discontinuation or dose escalation was compared between TNF inhibitors with multiple adjusted Cox proportional hazards models and multiple imputation for missing baseline covariate data. RESULTS: A total of 966 patients were included (adalimumab 344, etanercept 237, golimumab 214, infliximab 171). Patients on certolizumab (n = 18) were excluded. Patients starting golimumab had lower disease activity as well as better physical function and quality of life in comparison to patients starting another drug. A higher proportion of patients starting infliximab had a history of extra-articular manifestations. Drug dosage was more often escalated during follow-up in patients treated with infliximab than with subcutaneously administered agents. However, no significant differences in time up to drug discontinuation or dose escalation were observed in multiple adjusted analyses if treatment was initiated after 2009, when all 4 TNF inhibitors were available: hazard ratio for infliximab versus etanercept 1.16 (95% confidence interval 0.80; 1.67), p = 0.44, for golimumab versus etanercept 0.80 (0.58; 1.10), p = 0.17 and for adalimumab versus etanercept 0.93 (0.69; 1.26), p = 0.66. CONCLUSION: In axial spondyloarthritis, drug survival with standard doses of different TNF inhibitors is comparable.


Assuntos
Adalimumab/administração & dosagem , Anticorpos Monoclonais/administração & dosagem , Etanercepte/administração & dosagem , Infliximab/administração & dosagem , Espondilartrite/tratamento farmacológico , Adulto , Anti-Inflamatórios não Esteroides/administração & dosagem , Antirreumáticos/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Tempo , /administração & dosagem
20.
J Med Econ ; 22(8): 777-787, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30982378

RESUMO

Aims: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This analysis investigated the cost-effectiveness of the second-line treatment with tofacitinib, compared with adalimumab, both plus methotrexate (MTX), in patients with moderate-to-severe RA and an inadequate response to the first-line MTX, from a Taiwan National Health Insurance Administration perspective. Materials and methods: A patient-level simulation model was used to project lifetime costs and quality-adjusted life-years (QALYs). Base-case analysis compared second-line treatment with tofacitinib 5 mg twice daily plus MTX vs adalimumab 40 mg every 2 weeks plus MTX. Patients switched or discontinued treatment due to a lack or loss of effectiveness or a serious adverse event. Efficacy was measured by change in Health Assessment Questionnaire-Disability Index (HAQ-DI) score. HAQ-DI scores were used to predict mortality and resource utilization, and were mapped onto utility values to estimate QALYs. Efficacy and safety data were derived from clinical trials and other secondary sources. Uncertainty in model parameters was explored using one-way deterministic and probabilistic sensitivity analyses. Results: Patients gained 0.09 more QALYs with second-line tofacitinib plus MTX compared with adalimumab plus MTX (5.13 vs 5.04, respectively) at an additional cost of New Taiwan Dollars (NT$) 12,881. The incremental cost-effectiveness ratio was NT$143,122/QALY. One-way sensitivity analysis confirmed the base-case result was robust. Limitations: The lack of available clinical data, particularly for HAQ-DI scores, may introduce some bias in the analysis. No patients were in an early stage of RA, which may limit the generalizability of these results. Base-case results from our study are not necessarily generalizable to countries with healthcare systems that differ considerably from Taiwan. Conclusions: From a payer perspective, second-line treatment with tofacitinib plus MTX is a cost-effective treatment strategy, compared with adalimumab plus MTX, in patients with moderate-to-severe RA in Taiwan.


Assuntos
Adalimumab/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Piperidinas/uso terapêutico , Pirimidinas/uso terapêutico , Pirróis/uso terapêutico , Adalimumab/administração & dosagem , Adalimumab/economia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Antirreumáticos/administração & dosagem , Antirreumáticos/economia , Análise Custo-Benefício , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Modelos Econômicos , Piperidinas/administração & dosagem , Piperidinas/economia , Pirimidinas/administração & dosagem , Pirimidinas/economia , Pirróis/administração & dosagem , Pirróis/economia , Anos de Vida Ajustados por Qualidade de Vida , Índice de Gravidade de Doença , Taiwan , Adulto Jovem
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