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      Infliximab en pacientes con espondilitis anquilosante activa: experiencia en el Hospital Nacional Edgardo Rebagliati Martins Translated title: Infliximab in patients with active ankylosing spondylitis: experience at Hospital Nacional Edgardo Rebagliati Martins

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          Abstract

          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%) presentaban respuesta ASAS 20 sostenida. Cuatro (57%) y tres (43%) de los pacientes alcanzaron BASDAI 50 y ASAS 40, respectivamente. Tres pacientes (43%) 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.

          Translated abstract

          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%) had a sustained ASAS 20 response. Four (57%) and three (43%) patients remained responders according to the BASDAI 50 and ASAS 40 respectively.Three patients (43%) 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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          Most cited references37

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          Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria.

          The New York and the Rome diagnostic criteria for ankylosing spondylitis (AS) and the clinical history screening test for AS were evaluated in relatives of AS patients and in population control subjects. The New York criterion of pain in the (dorso) lumbar spine lacks specificity, and the chest expansion criterion is too insensitive. The Rome criterion of low back pain for more than 3 months is very useful. Our study showed the clinical history screening test for AS to be moderately sensitive, but it might be better in clinical practice. As a modification of the New York criteria, substitution of the Rome pain criterion for the New York pain criterion is proposed.
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            A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index.

            Disease status, in terms of disease activity, disease progression and prognosis is difficult to define in ankylosing spondylitis (AS). No gold standard exists. Therefore, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a self-administered instrument, has been developed as a new approach to defining disease activity in patients with AS. The index, designed by a multidisciplinary team with input from patients, consists of six 10 cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. The index was distributed to a cross section of patients, including inpatients receiving 3 weeks of intensive physiotherapy treatment and hospital outpatients. BASDAI was completed by a total of 154 patients. Validation of the new instrument was achieved through analysis of user friendliness, reliability (consistency), score distribution and sensitivity to change. Comparisons were made with a previous Bath disease activity index (DAI) and the Newcastle Enthesis Index. The BASDAI was found by patients to be quick and simple to complete (mean: 67 s). Test-retest reliability was good (r = 0.93; p < 0.001), as was the distribution of scores across the scale (score range: 0.5-10; mean: 4.31). BASDAI was sensitive to change, reflecting a 16% (mean) improvement in inpatient scores after 3 weeks of treatment. It is superior to the DAI in terms of construct and content validity and to the Enthesis Index in all aspects. In summary, BASDAI is user friendly, reliability, sensitive to change and reflects the entire spectrum of disease. It is a comprehensive self-administered instrument for assessing disease activity in AS.
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              Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT).

              The signs and symptoms of ankylosing spondylitis (AS) respond inadequately to nonsteroidal antiinflammatory drugs, corticosteroids, and disease-modifying antirheumatic drugs in quite a number of patients. Tumor necrosis factor inhibitors have demonstrated success in reducing AS disease activity in a limited number of clinical trials. The objective of this multicenter, randomized, placebo-controlled study was to evaluate the efficacy and safety of infliximab in patients with AS. Patients were randomly assigned to receive infusions of placebo or 5 mg/kg infliximab at weeks 0, 2, 6, 12, and 18. Efficacy was assessed using the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), night pain, patient's global assessment, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Metrology Index (BASMI), chest expansion, the Mander enthesis index, the total swollen joint index, the C-reactive protein level, and the Short Form 36 (SF-36) health survey questionnaire. The primary end point in this study was the proportion of patients with a 20% improvement response according to the ASAS International Working Group criteria (ASAS20 responders) at week 24. Of the 357 patients screened, 201 were assigned to receive 5 mg/kg infliximab and 78 were assigned to receive placebo. After 24 weeks, 61.2% of patients in the infliximab group were ASAS20 responders compared with 19.2% of patients in the placebo group (P < 0.001). Clinical benefit was observed in patients receiving infliximab as early as week 2 and was maintained over the 24-week study period. Patients receiving infliximab also showed significant improvements in the BASDAI, BASFI, BASMI, chest expansion, and physical component summary score of the SF-36. Adverse events were reported by 82.2% of patients receiving infliximab and by 72.0% of patients receiving placebo; however, most adverse events in both treatment groups were mild or moderate in severity. Infliximab was well tolerated and effective in a large cohort of patients with AS during a 24-week study period.
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                Author and article information

                Journal
                afm
                Anales de la Facultad de Medicina
                An. Fac. med.
                Universidad Nacional Mayor de San Marcos. Facultad de Medicina (Lima, , Peru )
                1025-5583
                June 2007
                : 68
                : 2
                : 175-180
                Affiliations
                [02] Lima orgnameUniversidad Nacional Mayor de San Marcos Perú
                [03] Nashville TN orgnameVanderbilt University USA
                [01] Lima orgnameEsSalud orgdiv1Hospital Nacional Edgardo Rebagliati orgdiv2Servicio de Reumatología Perú
                Article
                S1025-55832007000200010 S1025-5583(07)06800210
                620aad19-a461-464a-be02-175e49b9104e

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

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                SciELO Peru

                Self URI: Texto completo solamente en formato PDF (ES)
                Categories
                Comunicaciones cortas

                Espondilitis anquilosante,agentes antirreumáticos,enfermedades reumáticas,Spondylitis, ankylosing,antirheumatic agents,rheumatic diseases

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