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Las entidadessineson poco comunes en reumatología. En la esclerosis sistémica progresiva, hay una variante de la forma cutánea limitada llamada esclerosis sistémicasineesclerodermia, cuya característica central es la falta de afectación cutánea, pero compromiso visceral presente. La positividad a los anticuerpos antitopoisomerasa o anticentromérico confirman el diagnóstico. El caso de este estudio es una mujer de 63 años con enfermedad intersticial pulmonar, afectación del tránsito intestinal y fenómeno de Raynaud, con ANA a títulos elevados con patrón centromérico y positividad para anticuerpos antitopoisomerasa. Ante un paciente con fenómeno de Raynaud, afectación visceral y ANA elevado, se le debe pedir anticuerpos específicos para diagnóstico de esclerosis sistémica en su variedadsine.
Sine entities are rare in rheumatology. In progressive systemic sclerosis there is a variant of the limited cutaneous form called systemic sclerosis sine scleroderma, whose central feature is the lack of skin involvement, but visceral involvement is present. Positive anti-topoisomerase or anti-centromere antibodies confirm the diagnosis. We present the case of a 63-year-old woman with interstitial lung disease, intestinal transit involvement and Raynaud's phenomenon, with high titers of ANA with a centromeric pattern and positivity for anti-topoisomerase antibodies. When faced with a patient with Raynaud's phenomenon, visceral involvement and elevated ANA, specific antibodies should be requested for the diagnosis of systemic sclerosis in its sine variety.
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Introduction: Biological products, including infliximab (INF), are a therapeutic option for various medical conditions. In the Peruvian Social Security (EsSalud), infliximab is approved for the treatment of rheumatoid arthritis, psoriasis, psoriatic arthropathy, ankylosing spondylitis, ulcerative colitis and Crohn's disease (in cases refractory to conventional treatment). Biosimilars are a safe and effective alternative approved for these diseases in patients who start treatment with infliximab. Nevertheless, there are people in treatment with the biological reference product (BRP), in whom the continuing therapy with a biosimilar biological product (BBP) must be evaluated. Objectives: To synthesize the best available evidence, calculate a preliminary financial impact and conduct technical discussions about the interchangeability into biosimilar in patients receiving treatment with original infliximab for medical conditions approved in EsSalud. Methodology: We carried out a systematic review of controlled clinical trials. Primary search was performed in Pubmed- MEDLINE, SCOPUS, WOS, EMBASE, TRIPDATABASE, DARE, Cochrane Library, NICE, AHRQ, SMC, McMaster-PLUS, CADTH, and HSE until June-2018. We used the Cochrane Collaboration tool to assess the risk of bias. Also, we implemented a preliminary financial analysis about the impact of biosimilar introduction on institutional purchasing budget. Moreover, technical meetings with medical doctors specialized in rheumatology, gastroenterology and dermatology were held for discussing findings. Results: In primary search, 1136 records were identified, and 357 duplicates were removed. From 799 records, we excluded 765 after title and abstract evaluation. From 14 full-text appraised documents, we included five clinical trials in the risk of bias assessment: four studies evaluated CTP-13 and one tested SB2. Two double-blind clinical trials reported no differences in efficacy and safety profiles between maintenance group (INF/INF) and interchangeability group in all diseases included (INF/CTP-13) and rheumatoid arthritis (CTP13 and SB2). In the other three studies, open-label extension of primary clinical trials, no differences were founded in efficacy and safety profiles between CTP-13/CTP-13 and INF/CTP-13 groups. In financial analysis, the inclusion of biosimilars implied savings around S/7´642,780.00 (1USD=S/3.30) on purchasing budget of EsSalud. In technical meetings, beyond certain concerns, specialists agreed with the findings. Conclusions: Evidence from clinical trials support that there are no differences in efficacy or safety of continuing the treatment with Infliximab BRP or exchanging into its biosimilar in patients with medical conditions approved in EsSalud. Financial analysis shows that the biosimilar introduction produce savings in purchasing institutional budget. Therefore, based on cost-opportunity principle, exchanging into biosimilar in patients receiving the original Infliximab, is a valid therapeutic alternative in the Peruvian Social Security.
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OBJECTIVES: This study analysed the frequency of anterior uveitis (AU) and its correlations in a large cohort of patients with spondyloarthritis (SpA). METHODS: A common protocol of investigation was prospectively applied to 2012 SpA patients in 85 centres from 10 Ibero-American countries. Clinical and demographic variables and disease indexes were investigated. Categorical variables were compared by χ2 and Fisher's exact test, and continuous variables were compared by ANOVA or Kruskal-Wallis test. A value of p<0.05 was considered significant. RESULTS: AU was referred by 372 SpA patients (18.5%). AU was statistically associated with inflammatory low back pain (p<0.001), radiographic sacroiliitis (p<0.001), enthesopathies (p=0.004), urethritis/acute diarrhoea (p<0.001), balanitis (p=0.002), hip involvement (p=0.002), HLA-B27 (p=0.003), and higher C-reactive protein (p=0.001), whilst it was negatively associated with the number of painful (p=0.03) and swollen (p=0.005) peripheral joints, psoriatic arthritis (p<0.001), psoriasis (p<0.001), nail involvement (p<0.001), and dactilitis (p=0.062; trend). No association with gender, race, and indices (disease activity, functionality and quality of life) was observed. Logistic regression showed that ankylosing spondylitis (p=0.001) and HLA-B27 (p=0.083; trend) was significantly associated with AU, while extra-articular manifestations (predominantly psoriasis) were negatively associated (p=0.016). CONCLUSIONS: Anterior uveitis is a frequent extra-articular manifestation in SpA patients, positively associated with axial involvement and HLA-B27 and negatively associated with peripheral involvement and psoriatic arthritis.
Assuntos
Antígeno HLA-B27/metabolismo , Psoríase/epidemiologia , Espondilartrite/epidemiologia , Uveíte Anterior/epidemiologia , Adolescente , Adulto , América Central/epidemiologia , Feminino , Humanos , Articulações/patologia , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Prospectivos , Psoríase/metabolismo , Psoríase/patologia , Sistema de Registros/estatística & dados numéricos , América do Sul/epidemiologia , Espondilartrite/metabolismo , Espondilartrite/patologia , Uveíte Anterior/metabolismo , Uveíte Anterior/patologia , Adulto JovemRESUMO
OBJECTIVE: To describe differential characteristics of axial involvement in ankylosing spondylitis (AS) as compared with that seen in psoriatic arthritis (PsA) and inflammatory bowel disease (IBD) in a cohort of Ibero-American patients. METHODS: This study included 2044 consecutive patients with spondyloarthritis (SpA; ESSG criteria). Demographic, clinical, disease activity, functional ability, quality of life, work status, radiologic, and therapeutic data were evaluated and collected by RESPONDIA members from different Ibero-American countries between June and December 2006. Patients selected for analysis met modified New York criteria (mNY) for AS. RESULTS: A total of 1264 patients met the New York criteria for AS: 1072 had primary AS, 147 had psoriatic, and 45 had IBD-associated spondylitis. Median disease duration was comparable among the 3 patient groups. Patients with primary AS were significantly younger (p = 0.01) and presented a higher frequency of males (p = 0.01) than the other 2 groups. Axial manifestations such as inflammatory back pain and sacroiliac pain were significantly more frequent in patients with primary AS (p = 0.05) versus other groups, whereas frequency of dactylitis, enthesitis, and peripheral arthritis was more common in patients with psoriatic spondylitis (p = 0.05). Spinal mobility was significantly more limited in patients with primary AS versus the other 2 groups (p = 0.0001). Radiologic changes according to BASRI total score were equally significant in primary AS. Disease activity (BASDAI), functional ability (BASFI), and quality of life (ASQoL) scores were comparable in the 3 groups. CONCLUSION: Patients with primary AS had more severe axial involvement than those with spondylitis associated with psoriasis or IBD. Functional capacity, disease activity, and quality of life were comparable among the groups studied.
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Artrite Psoriásica/complicações , Artrite Psoriásica/fisiopatologia , Doenças Inflamatórias Intestinais/complicações , Doenças Inflamatórias Intestinais/fisiopatologia , Espondilartrite/etiologia , Espondilartrite/fisiopatologia , Espondilite Anquilosante/fisiopatologia , Adulto , Artrite Psoriásica/patologia , Estudos Transversais , Bases de Dados Factuais , Feminino , Humanos , Doenças Inflamatórias Intestinais/patologia , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Espondilartrite/patologia , Espondilite Anquilosante/patologia , Inquéritos e QuestionáriosRESUMO
Infliximab es un medicamento efectivo en el tratamiento de pacientes con espondilitis anquilosante (EA) activa. Sin embargo, debido a su alto costo, su uso indiscriminado es prohibitivo. Objetivo: Evaluar si un régimen de inducción con infliximab es efectivo en pacientes con EA activa. Diseño: Sólo expuestos. Lugar: Servicio de Reumatología del Hospital Nacional Edgardo Rebagliati. Participantes: Pacientes con espondilitis anquilosante activa refractaria. Intervenciones: infliximab a las 0, 2 y 6 semanas. Un paciente recibió dosis de 3 mg/kg y los restantes 5 mg/kg de infliximab. Todos los pacientes continuaron recibiendo sulfasalazina. Principales medidas de resultados: Se determinó la proporción de pacientes que alcanzaron mejoría de acuerdo a los criterios ASAS 20, ASAS 40 y BASDAI 50, en la última evaluación (mediana de 55 semanas). Resultados: En la última evaluación, cinco pacientes (71,4 por ciento) presentaban respuesta ASAS 20 sostenida. Cuatro (57 por ciento) y tres (43 por ciento) de los pacientes alcanzaron BASDAI 50 y ASAS 40, respectivamente. Tres pacientes (43 por ciento) recayeron en un tiempo promedio de 26,6 semanas. No se observó efectos adversos serios. Conclusiones: La infusión de tres dosis de infliximab es efectiva para controlar la actividad de la enfermedad de los pacientes con EA refractaria a AINEs y en algunos pacientes controla la enfermedad por periodos prolongados de tiempo.
Infliximab is effective in treating patients with ankylosing spondylitis (AS). However, its cost makes its indiscrimate use prohibitive. Objective: To determine whether an induction regimen with infliximab remained effective over time in a group of patients with active AS. Design: Exposed only. Setting: Rheumatology Service, Hospital Nacional Edgardo Rebagliati. Participants: Patients with active and refractory ankylosing spondylitis. Interventions: Infliximab administered at weeks 0, 2 and 6. One patient received doses of 3 mg/kg and the remaining patients received 5 mg/kg of infliximab. All patients continued their treatment with sulfasalazine. Main outcome measures: We determined the proportion of patients achieving ASAS 20, ASAS 40 and Bath ankylosing spondylitis disease activity index - BASDAI 50 at last assessment (median of 55 weeks). Results: At last observation, five patients (71,4 per cent) had a sustained ASAS 20 response. Four (57 per cent) and three (43 per cent) patients remained responders according to the BASDAI 50 and ASAS 40 respectively. Three patients (43 per cent) relapsed, with mean time of 26,6 weeks. No serious adverse events were observed. Conclusions: The infusion of three doses of infliximab is effective to control disease activity in patients with refractory AS. In some patients, effectiveness remained for a prolonged period of time.
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Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Antirreumáticos/administração & dosagem , Doenças Reumáticas , Espondilite Anquilosante/terapiaRESUMO
Se evaluaron en un estudio prospectivo a 91 pacientes con diagnóstico de osteoartrosis que recibieron tratamiento con glicosaminoglicano polisulfato (GAGPS):85 fueron tratados por vía IM y 6 por vía intrarticular. Los parámetros clínicos estudiados fueron: dolor en reposo, dolor al movimiento, rigidez post- reposo, crujido y limitación funcional. A todos los pacientes al inicio y al final del estudio se les solicitó radiografías y exámenes de sangre y orina. Los resultados demuestran que mas del 75 por ciento de pacientes observaron mejoría estadísticamente significativa en todos los parámetros, excepto el crujido articular que requiere una evaluación a largo plazo. El fármaco es de uso seguro por cuanto los efectos secundarios fueron escasos. El mecanismo de acción del GAPS es por acumulación en el cartilago, evitando de esta manera su degradación al inhibir enzimas proteolíticas. El GAPS es una buena alternativa en el tratamiento de la osteoartrosis.
We evaluated prospectively the efficacy of polysulfated glycosaminglycan (GAPS) in the treatment of osteoarthrosis. We studies 91 patients, 85 received the drug by intramuscular route and 6 by intrarticular route. The improve were measured by pain on rest, pain on movement, stiffnes and functional incapacity in all the patients a X-ray plain of knees and routine laboratory tests. Our results show that more than 75 per cent of patients have a satatistical significative improve in all the parameters evaluated. The mechanism fo actions is by accumulation in the cartilage, avoiding the cartilage degradation. The secondary side effects were mild. We concluded that GAGPS are effectively a in the treatment of osteoarthrosis.