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1.
Expert Opin Biol Ther ; 16(11): 1317-1322, 2016 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-27537179

RESUMO

OBJECTIVE: The objective of this is manuscript is to evaluate the impact of a vaccination protocol in the prevention of infection in autoimmune inflammatory disease (AUTID) patients treated with Anti-TNF-alpha therapies. RESEARCH DESIGN AND METHODS: The authors conducted an observational study to test the effect of a vaccination program in AUTID patients that received anti-TNF-alpha therapies in hospital admissions related to infections. This effect was evaluated by comparing patients admitted before the program started (prevaccination period, 2009-2011) and after the program (postvaccination period, 2011-2014). RESULTS: The study included 581 patients: 280 in the pre-vaccination group and 301 in the post-vaccination group. During the prevaccination period, 27.3% of patients treated with anti-TNF-alpha drugs were vaccinated before biological therapy. During the postvaccination period, this percentage increased to 97.0%. Statistically significant differences were detected in emergency room visits per 10.000 treatment days, in hospital admissions related to an infectious disease and in the rate of invasive pneumococcal disease due to Streptococcus pneumoniae infection per 10.000 days of treatment. CONCLUSIONS: This vaccination program decreases infectious complications and was associated with a lower amount of hospital admissions due to infections, emergency room visits and the rate of invasive pneumococcal disease.

2.
Mod Rheumatol ; 26(3): 336-341, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26418571

RESUMO

OBJECTIVE: To assess effectiveness and safety of certolizumab PEGol (CZP) in rheumatoid arthritis (RA) patients after 12 months of treatment and to detect predictors of response. METHODS: Observational longitudinal prospective study of RA patients from 35 sites in Spain. Variables (baseline, 3- and 12-month assessment): sociodemographics, previous Disease Modifying Anti-Rheumatic Drug (DMARD) and previous Biological Therapies (BT) use; TJC, SJC, ESR, CRP, DAS28, SDAI. Response variables: TJC, SJC, CRP, ESR, and steroids dose reductions, EULAR Moderate/Good Response, SDAI response and remission, DAS28 remission. Safety variables: discontinuation due to side-effects. Descriptive, comparative and Logistic regression analyses were performed. RESULTS: We included 168 patients: 79.2% women, mean age 54.5 years (±13.2 SD), mean disease duration 7.5 years (±7.3 SD). Mean number of prior DMARD: 1.4 (±1.2 SD), mean number of prior BT was 0.8 (±1.1). Mean time on CZP was 9.8 months (±3.4 SD). A total of 71.4% were receiving CZP at 12-month assessment. Baseline predictors of response: lower prior number DMARD; low number prior BT; higher CRP, ESR, TJC, SJC, DAS28 and SDAI (p < 0.05) scores. A 25/46.4% Moderate/Good Response, a 20% SDAI remission, and a 44% DAS28 remission were observed. We observed 48 discontinuations (28.6%), 31 due to partial or complete ineffectiveness, and 17 due to side-effects. CONCLUSIONS: CZP showed benefit in severe RA patients, with significant reduction of all effectiveness parameters, despite the high prevalence of previous BT exposure in our series. We found CRP, ESR, prior DMARD/BT number, TJC, SJC, DAS28, and SDAI as baseline predictors of response. CZP was mostly well tolerated.

3.
Expert Opin Biol Ther ; 14(2): 145-50, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24359492

RESUMO

OBJECTIVE: To determine the clinical and economic impact of etanercept 25 mg/week (ETN25) on rheumatoid arthritis (RA), psoriatic arthropathy (PA) and ankylosing spondylitis (AS) patients in sustained clinical remission. METHODS: Observational, retrospective cohort of patients treated with etanercept 50 mg/week (ETN50) who achieved and maintained clinical remission (Disease Activity Score 28 < 2.6 or BASDAI < 2) over a period of 1 year and had slow worsening of structural changes were enrolled in an off-label program (January 2006 to June 2013) to switch from ETN50 to ETN25. Economic impact was assessed using Enbrel® official prices for Spain. RESULTS: From 1 January 2006 to 1 June 2013, 98 RA, 40 PA and 47 AS patients were treated with ETN50; 39 (24%) patients (20 women; age = 53 ± 7 years; 24 RA, 7 PA, 8 AS) received ETN25 for at least 0.5 years (2.6 ± 2.0 years; range = 0.5 - 7.3 years). As of 1 June 2013, 29 (74%) patients continued on ETN25. RA patients: 17 patients continued on ETN25, 5 patients discontinued use due to reactivation of RA (4 switched back to ETN50 and 1 switched to adalimumab; all regained clinical remission) and 2 patients discontinued use due to adverse reactions. PA patients: four patients continued on ETN25, two patients discontinued use due to reactivation of PA (switched back to ETN50, regaining clinical remission) and one patient discontinued use due to adverse reaction. All AS patients continued on ETN25. The total savings associated with ETN25 over the 7-year observation period were €622,073, resulting in the ability to treat 52 additional patients with ETN50 for one year without increasing total ETN costs. CONCLUSION: ETN25 produces cost savings while maintaining clinical response in a high proportion of patients after at least one year under clinical remission with ETN50. At a time when the cost of therapy is an unavoidable component of healthcare treatment decisions, ETN25 could be a cost-effective option for selective RA, PA and AS patients.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Imunoglobulina G/administração & dosagem , Imunoglobulina G/economia , Receptores do Fator de Necrose Tumoral/administração & dosagem , Espondilite Anquilosante/tratamento farmacológico , Adulto , Antirreumáticos/administração & dosagem , Antirreumáticos/economia , Artrite Psoriásica/economia , Artrite Reumatoide/economia , Análise Custo-Benefício , Progressão da Doença , Custos de Medicamentos , Etanercepte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Estudos Retrospectivos , Espanha , Espondilite Anquilosante/economia , Resultado do Tratamento
4.
Expert Opin Biol Ther ; 13(8): 1103-8, 2013 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23675687

RESUMO

OBJECTIVE: To assess patients' acceptability of switching etanercept from the prefilled syringe to the autoinjection pen in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis patients. METHODS: A two-phase cross-sectional study was designed. First phase: consisted of a 2 h information/education session to present the pen and learning its use. At the end of the session, patients completed a self-administered questionnaire regarding the meeting usefulness. Second phase: eight single-use prefilled Enbrel® Pen Myclic were provided. RESULTS: The number of patients included were 104 (rheumatoid arthritis 58, psoriatic arthritis 31, ankylosing spondylitis 15). Attendees showed a high satisfaction degree with the meeting. A high percentage of patients (74.4 - 95.1%) rated the items of the questionnaire as 'very much'. Patients reported > 95% adherence to etanercept autoinjection pen. The percentage of patients self-administering etanercept increased from 66 to 94% and the percentage of those attending primary care for injection decreased from 23 to 2%. It produced important cost savings, in our study represents > 22.000 euros/year. Pain at the injection site was significantly reduced with the use of autoinjection pen. Ninty seven (93%) patients considered that the use of the autoinjection pen was easier than the syringe and 94.2% chose the pen as their preferred delivery system. CONCLUSIONS: The autoinjection pen is an advantageous delivery option for etanercept. This study provides further evidence to support that the education strategy is a valid method for switching anti-TNF-α drugs from syringe to pen in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.


Assuntos
Antirreumáticos/administração & dosagem , Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Sistemas de Liberação de Medicamentos/instrumentação , Imunoglobulina G/administração & dosagem , Satisfação do Paciente/estatística & dados numéricos , Receptores do Fator de Necrose Tumoral/administração & dosagem , Espondilite Anquilosante/tratamento farmacológico , Antirreumáticos/uso terapêutico , Estudos Transversais , Substituição de Medicamentos , Etanercepte , Feminino , Seguimentos , Humanos , Imunoglobulina G/uso terapêutico , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Receptores do Fator de Necrose Tumoral/uso terapêutico , Autoadministração/instrumentação , Seringas
5.
Expert Opin Biol Ther ; 10(3): 301-7, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-20059372

RESUMO

OBJECTIVE: To assess patients' acceptance of switching adalimumab from a prefilled syringe to an autoinjection pen. METHODS: A two-phase cross-sectional study. The first phase consisted of a 2-h information/education session to present the pen and assist patients in learning its use. At the end of the session, patients completed a self-administered questionnaire regarding usefulness of the meeting. At the next hospital pharmacy dispensing visit the autoinjection pen was provided. Four single-use prefilled devices (40 mg/0.8 ml every other week) were provided. RESULTS: The study population included 55 patients (rheumatoid arthritis 29, psoriatic arthritis 17, ankylosing spondylitis 9). Attendees showed a high degree of satisfaction with the education session (between 72.7 and 90.9% rated the relevant items of the questionnaire in the highest category). Fifty-one patients participated in the second phase of the study. Patients reported 100% adherence to treatment with the autoinjection pen. The percentage of patients self-administering medication increased from 51 to 84% and the percentage attending primary care for injection decreased from 33 to 2%. Pain at the injection site was significantly reduced with the use of the autoinjection pen. The mean (sd) visual analogue scale (VAS) score was 3.52 (2.26) for the syringe compared with 2.02 (2.16) for the pen (p < 0.001). Forty-four (86.3%) patients considered that the use of the autoinjection pen was easier than the syringe, and 96.1% chose the pen as their preferred delivery system. CONCLUSIONS: This study provides further evidence to support the use of the autoinjection pen as a delivery option for adalimumab therapy.


Assuntos
Anticorpos Monoclonais/administração & dosagem , Antirreumáticos/administração & dosagem , Artrite Reumatoide/tratamento farmacológico , Seringas , Adalimumab , Anticorpos Monoclonais/uso terapêutico , Anticorpos Monoclonais Humanizados , Antirreumáticos/uso terapêutico , Artrite Reumatoide/psicologia , Estudos Transversais , Humanos , Cooperação do Paciente , Educação de Pacientes como Assunto , Satisfação do Paciente
6.
South Med J ; 102(3): 304-5, 2009 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19204628

RESUMO

A 50-year-old woman was referred to our emergency room because of urticaria. Eleven days after etanercept therapy was started, the patient developed an urticarial rash of the trunk and face. A diagnosis of generalized urticaria was made. Etanercept treatment was suspended. Treatment was started with methylprednisolone and dexchlorpheniramine. The patient's condition improved and she was discharged. In this case, the most probable cause of urticaria was considered to be etanercept because of the temporal relationship between exposure to the drug and the onset of symptoms. The adverse reaction could be considered probable. Although the overall risk of skin adverse events associated with etanercept appears low, clinicians should be aware of this reaction.


Assuntos
Artrite Psoriásica/tratamento farmacológico , Imunoglobulina G/efeitos adversos , Fatores Imunológicos/efeitos adversos , Urticária/induzido quimicamente , Etanercepte , Feminino , Humanos , Pessoa de Meia-Idade , Receptores do Fator de Necrose Tumoral
7.
Ann Pharmacother ; 41(2): 341-4, 2007 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-17227824

RESUMO

OBJECTIVE: To report a case of parapharyngeal abscess associated with Streptococcus viridans in a patient with rheumatoid arthritis receiving treatment with etanercept. CASE SUMMARY: A 40-year-old man diagnosed with rheumatoid arthritis had received treatment with nonsteroidal antiinflammatory drugs, methotrexate, and deflazacort. Six months prior to admission, the patient had a Disease Activity Score of 3.4; clinicians decided to start treatment with etanercept. Chest X-rays were normal and the tuberculin skin test was negative. Treatment with etanercept plus methotrexate was started. Three months later, methotrexate was discontinued. Six months after etanercept therapy was started, the patient presented to our emergency department with a swelling of his neck, odynophagia, otalgia, and trismus. The clinical course was consistent with parapharyngeal abscess. Etanercept treatment was suspended. The parapharyngeal abscess was drained and intravenous methylprednisolone, amoxicillin/clavulanic acid, and clindamycin were administered. The parapharyngeal abscess secretion culture was positive for S. viridans and Bacteroides spp. The patient's condition improved with antibiotic therapy; he was discharged 5 days after admission. DISCUSSION: Tumor necrosis factor-alpha plays an essential role in the immune-mediated response to infection. In our patient, the most possible cause of parapharyngeal abscess was considered to be etanercept because of the temporal relationship between exposure to the drug and onset of symptoms. Etanercept was the only drug administered before the abscess developed. Based on the Naranjo probability scale, an association between etanercept and the adverse reaction could be considered possible. CONCLUSIONS: Patients initiated on etanercept therapy should be closely monitored for the development of tuberculosis and other infections. During treatment, all febrile or novel illnesses should be evaluated promptly. If clinical evaluation leads to the suspicion of tuberculosis and other infections associated with etanercept, it should be discontinued immediately.


Assuntos
Abscesso/etiologia , Anti-Inflamatórios não Esteroides/efeitos adversos , Imunoglobulina G/efeitos adversos , Imunossupressores/efeitos adversos , Doenças Faríngeas/etiologia , Infecções Estreptocócicas/etiologia , Estreptococos Viridans/isolamento & purificação , Abscesso/tratamento farmacológico , Abscesso/microbiologia , Adulto , Antibacterianos/uso terapêutico , Anti-Inflamatórios não Esteroides/administração & dosagem , Anti-Inflamatórios não Esteroides/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Etanercepte , Humanos , Imunoglobulina G/administração & dosagem , Imunoglobulina G/uso terapêutico , Imunossupressores/administração & dosagem , Imunossupressores/uso terapêutico , Masculino , Doenças Faríngeas/tratamento farmacológico , Doenças Faríngeas/microbiologia , Receptores do Fator de Necrose Tumoral/administração & dosagem , Receptores do Fator de Necrose Tumoral/uso terapêutico , Infecções Estreptocócicas/tratamento farmacológico , Infecções Estreptocócicas/microbiologia , Resultado do Tratamento , Estreptococos Viridans/efeitos dos fármacos
8.
In. Congresso Internacional de Leprologia, 6. Congresso Internacional de Leprologia, 6/Memoria. Madrid, Asociacion Internacional de la Lepra, Oct. 1953. p.295-8.
Não convencional em Espanhol | Hanseníase | ID: han-2264
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