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INTRODUCTION: Many regions in the middle of Germany have a deficit in specialized rheumatological care. A survey was undertaken to investigate whether the regional capacities for rheumatological advanced training are sufficient to provide an adequate number of rheumatologists in the future. METHODS: All 91 rheumatologists registered in Saxony, Saxony-Anhalt and Thuringia received a questionnaire that was sent back by 66% of the recipients (23 responses from Saxony, 19 from Saxony-Anhalt, 18 from Thuringia). Of the rheumatologists 41 were in private practice, 19 worked in an inpatient department and the mean duration of professional activity was 18 years. RESULTS: Over the last decade the number of patients treated by rheumatologists in private practices increased from 1200 to 1500 per quarter year (pâ¯< 0.001), whereas the number of first consultations rose from 100 to 130 per quarter year (pâ¯= 0.06). The waiting time for a first consultation rose from 8 to 11 weeks (pâ¯= 0.01), 32% of the responders indicated that the conditions for outpatient treatment had either improved or had remained constant during the last 10 years, whereas 60% reported a mild or marked deterioration and 48% stated that the number of rheumatologists had decreased within the same time frame. Only 20% indicated that they had a definite successor in the practice after retirement. All inpatient departments also had an outpatient office. During the last 10 years, the number of consultations per quarter year decreased from 1100 to 700 (not significant), while the waiting time doubled from 6 to 12 weeks (rounded mean). Of the rheumatologists in private practice eight are currently entitled to provide advanced education in rheumatology, with a median training period of 18 months; however, none of the responding physicians had actually brought assistant doctors to the final examination during the last decade and only one prospective rheumatologist was currently completing training in a private practice setting. Only 6 out of 12 inpatient rheumatological facilities are entitled to educate rheumatologists over the whole training period, 5 facilities were not involved in training at all and 7 indicated that they lacked applications for rheumatology training. During the last 10 years, 37 rheumatologists completed the training of which 18 went into private practice, 8 worked as general practitioners and 29 remained in the region of their initial training. CONCLUSION: Given the increase in the number of outpatients served, the volume of training activities in rheumatology is hardly sufficient to improve the deficit of rheumatological care in the middle of Germany.
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Necesidades y Demandas de Servicios de Salud , Reumatólogos/psicología , Reumatología/educación , Reumatología/estadística & datos numéricos , Alemania , Humanos , Estudios Prospectivos , Enfermedades Reumáticas/epidemiología , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To investigate willingness to pay (WTP) for treatment with infliximab by patients with ankylosing spondylitis (AS) and explore factors associated with WTP. METHODS: Data from 85 patients participating in the European AS Infliximab Cohort (EASIC) open-label extension of the AS Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT) were used. WTP was included at baseline in EASIC and comprised a hypothetical scenario exploring whether the patient would be willing to pay for beneficial effects of infliximab and, if so, what amount they would be willing to pay per administration. Factors associated with WTP were explored using zero-inflated negative binomial (ZINB) regressions. RESULTS: Of the 85 patients, 63 (74.1%) were willing to pay, and among these, the mean amount they were willing to pay per administration was 275 (median 100 [interquartile range 50-200]). Multivariable ZINB analysis showed that Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response was associated with a 7-fold lower likelihood to pay 0 euros (odds ratio [OR] 0.14 [95% confidence interval (95% CI) 0.03-0.71]) and a 3-fold increase in the amount willing to pay (exp(ß) = 3.32 [95% CI 1.44-7.69]). In addition, the country of residence was associated with a lower likelihood to pay 0 euros (OR 0.07 [95% CI 0.02-0.36]), while increased age was associated with the amount willing to pay (exp(ß) = 1.05 [95% CI 1.01-1.09]). CONCLUSION: In a hypothetical scenario, three-quarters of patients with AS receiving long-term infliximab stated that they were willing to pay an out-of-pocket contribution for this treatment. Treatment response contributed to the willingness as well as to the amount patients were willing to pay.
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Productos Biológicos/economía , Productos Biológicos/uso terapéutico , Costos de los Medicamentos , Financiación Personal/economía , Gastos en Salud , Infliximab/economía , Infliximab/uso terapéutico , Aceptación de la Atención de Salud , Pacientes/psicología , Espondilitis Anquilosante/tratamiento farmacológico , Espondilitis Anquilosante/economía , Adulto , Análisis Costo-Beneficio , Europa (Continente) , Femenino , Conocimientos, Actitudes y Práctica en Salud , Humanos , Masculino , Persona de Mediana Edad , Espondilitis Anquilosante/psicologíaRESUMEN
BACKGROUND: In patients with tender and swollen finger joints, the differential diagnosis between rheumatoid arthritis (RA) and osteoarthritis (OA) of the hands can be initially difficult. This prospective study (the TryCort study) was performed to study the diagnostic value of prednisolone in differentiating between RA and hand OA. We present the results of this potentially diagnostic test in patients with possible RA in daily clinical practice by demonstrating the results of a pilot and a validation part of this 'prednisolone test' (pred-test). METHODS: We investigated the response to a 3-day course of 20 mg of prednisolone in patients with suspicion of RA. All patients received 1 g of paracetamol per day for 5 days for pain relief. On days 3-5, a morning dose of 20 mg of prednisolone was added. Hand pain was quantified on a 0-10 Numerical Rating Scale, and the subjective percentage of improvement (0-100%) was recorded. Thresholds for response to prednisolone were investigated in a pilot phase with differentiation in response between patients with RA and patients with OA of the hands, both with pain in the hands ≥4. In a validation phase, the best differentiating cut-off of the pilot phase was applied to discriminate responders from non-responders in consecutive patients with hand pain ≥4 referred because of suspected RA. Final diagnoses were made by the expert upon re-examination at week 12. Primary outcomes were the sensitivity and specificity of a positive test in relation to the diagnosis. RESULTS: A percentage of 40% subjective improvement of pain in the hands on day 3 discriminated best between RA and OA in the pilot phase. Among 95 patients with complete data in the validation phase, RA was diagnosed in about 50%. Patients with RA had more swollen joints, higher C-reactive protein levels and slightly higher Health Assessment Questionnaire scores. The pred-test was positive in 42.1% of all patients (40 of 95). The median percentage of improvement on day 5 was higher in RA than in non-RA: 50% (IQR 30-60%) vs. 20% (IQR 10-30%) (p < 0.001). The sensitivity and specificity of the pred-test were 0.6 (95% CI 0.5-0.8) and 0.8 (95% CI 0.7-0.9), respectively, and the positive and negative predictive values were 0.77 and 0.70, respectively. CONCLUSIONS: To our knowledge, this is the first evaluation of the widely used pred-test that has ever been performed. The pred-test had a moderate sensitivity and a good specificity. We conclude that rheumatologists may use this test in unclear clinical situations to better differentiate between inflammatory and other conditions. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01395251 . Registered on 14 Jul 2011. EudraCT number: 2011-002633-19. Registered on 21 Dec 2011.
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Antiinflamatorios/uso terapéutico , Artritis Reumatoide/diagnóstico , Osteoartritis/diagnóstico , Prednisolona/uso terapéutico , Anciano , Artritis Reumatoide/tratamiento farmacológico , Diagnóstico Diferencial , Femenino , Articulaciones de los Dedos , Humanos , Masculino , Persona de Mediana Edad , Osteoartritis/tratamiento farmacológico , Proyectos Piloto , Sensibilidad y EspecificidadRESUMEN
OBJECTIVE: Neck pain is common in rheumatoid arthritis (RA) and ankylosing spondylitis (AS). We investigated the correlation of bone marrow edema (BME) on magnetic resonance imaging (MRI) in RA and AS and its association with clinical complaints of neck pain. METHODS: Cervical spine short-tau inversion recovery-MRI and T1w-MRI of 34 patients with RA and 6 patients with AS complaining about neck pain were obtained. Clinical and laboratory data were available. BME was scored by 2 blinded readers using a modification of a published score, including various cervical sites. Degenerative changes were also quantified. RESULTS: Patients were predominantly women (82.5%), and mean ± SD age was 57.5 ± 11.8 years, C-reactive protein (CRP) was 0.8 ± 1.3 mg/dl, and pain score was 46.0 ± 17.5. BME was detected in 24/40 patients (60%) involving the atlantoaxial region (21%), vertebral bodies (75%), facet joints (29%), and spinous processes (46%). Degenerative changes were identified in 21/40 patients (52.5%), 13 (62%) of whom also had BME in vertebral bodies. No differences were found between patients with versus without cervical BME for clinical assessments: numeric rating scale pain (median ± interquartile range) 5.5 ± 3.0 vs 6.0 ± 4.0 (p = 0.69), Funktionsfragebogen Hannover 68.2 ± 41.0 vs 42.0 ± 55.5 (p = 0.19), Northwick pain score 44.4 ± 21.8 vs 47.2 ± 27.0 (p = 0.83), or CRP 0.40 ± 0.80 vs 0.60 ± 0.66 (p = 0.94). For patients with degenerative changes, symptom duration was longer than for patients without (10 ± 12.5 vs 5.0 ± 18.0 yrs, p = 0.73). CONCLUSION: In this small study of patients with RA and AS complaining about neck pain, BME was found in many different cervical sites, including the facet joints and the spinous processes. However, the occurrence and severity of BME did not correlate with the severity of neck pain.
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Artritis Reumatoide/diagnóstico por imagen , Médula Ósea/diagnóstico por imagen , Edema/diagnóstico por imagen , Hipertelorismo/diagnóstico por imagen , Discapacidad Intelectual/diagnóstico por imagen , Cifosis/diagnóstico por imagen , Megalencefalia/diagnóstico por imagen , Dolor de Cuello/diagnóstico por imagen , Espondilitis Anquilosante/diagnóstico por imagen , Lengua/anomalías , Adulto , Anciano , Artritis Reumatoide/complicaciones , Artritis Reumatoide/patología , Médula Ósea/patología , Edema/complicaciones , Edema/patología , Femenino , Humanos , Hipertelorismo/patología , Discapacidad Intelectual/patología , Cifosis/patología , Imagen por Resonancia Magnética , Masculino , Megalencefalia/patología , Persona de Mediana Edad , Dolor de Cuello/complicaciones , Dolor de Cuello/patología , Índice de Severidad de la Enfermedad , Espondilitis Anquilosante/complicaciones , Espondilitis Anquilosante/patología , Lengua/diagnóstico por imagen , Lengua/patologíaRESUMEN
OBJECTIVES: Knowledge on the long-term effects of anti-TNF therapy in patients with ankylosing spondylitis (AS) is still limited. Our objective was to study the long-term efficacy and safety of anti-TNF therapy in AS. METHODS: After having completed the first part of the EASIC trial a total of 71 patients were enrolled into this 96-week extension study. Patients were treated with the same dosages and dosing intervals of infliximab as in the EASIC core study. Efficacy was assessed by using standardised assessment tools such as BASDAI, BASFI, BASMI, patient global assessment, CRP levels and the proportion of patients without any sign of enthesitis or arthritis. Long-term safety was assessed by documenting adverse events (AE), serious adverse events (SAE) and reasons for dropping out. RESULTS: Of the 71 patients included, 64 (90.1%) completed the trial , and 7 discontinued: one was lost to follow-up, 3 withdrew informed consent and in 3 patients therapy was stopped for different reasons: secondary loss of response, recurrent infections and basal cell carcinoma of the skin. The completers showed rather stable low scores of BASDAI (mean 2.4, median 2.52), BASFI (mean 3.1, median 2.76) and BASMI (mean 3.2, median 3) as well as patients global assessment and CRP. The vast majority of patients did not have enthesitis or arthritis. A total of 476 AE were observed, 13 of which were SAE. The majority of these were infections and most of them affected the respiratory tract. Two malignancies occurred: one basal cell carcinoma and one malignant melanoma. These were the only SAE judged to be possibly related to the study drug. CONCLUSIONS: Anti-TNF treatment with infliximab is efficacious over long periods of time in patients with AS. The observation of two skin related malignancies, including one melanoma, during the whole study period of 7 years is in line with reports from previous large AS data sets.
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Antirreumáticos/uso terapéutico , Infliximab/uso terapéutico , Espondilitis Anquilosante/tratamiento farmacológico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adulto , Antirreumáticos/efectos adversos , Proteína C-Reactiva/análisis , Estudios de Cohortes , Femenino , Humanos , Infliximab/efectos adversos , Masculino , Persona de Mediana Edad , Espondilitis Anquilosante/sangreRESUMEN
OBJECTIVE: To investigate whether patients with ankylosing spondylitis (AS) adapt to their disease, using the 'then-test'. METHODS: Data from patients participating in the AS Study for Evaluation of Recombinant Infliximab Therapy (ASSERT) and continuing in the European AS Infliximab Cohort (EASIC) were used. At 5 assessments in EASIC, patients were asked to rerate their global well-being before the start of infliximab in ASSERT. The patients evaluated their past situation by using a 'then-test' ('retrospective patient global'). Initial and retrospective patient global were compared using a paired t test, and mixed linear models investigated whether the retrospective score of well-being was stable at all follow-up assessments in EASIC. Linear regression analysis explored whether treatment response was associated with the difference between the initial and retrospective score ('gap') while adjusting for possible confounders. RESULTS: 86 patients (mean age 39.8â years (SD=10.4), mean disease duration 10.8â years (SD=8.5)) contributed to the current analyses. At the time of starting infliximab, patients judged their global at 7.0 (SD=1.6), and with the 'then-test' at 7.2 (SD=2.3) (p=0.45). Time elapsed did not influence the 'then-test' (p=0.13). Multivariably, the gap was irrespective of treatment response, but associated with initial patient global (p<0.01) and initial Bath AS Disease Activity Index (p=0.02). CONCLUSIONS: Patients with AS accurately judged their global well-being before starting treatment with tumour necrosis factor inhibition, even though substantial time had elapsed. The difference between initial and retrospective judgment was irrespective of treatment response. In this setting, the 'then-test' could not prove adaptation in AS. TRIAL REGISTRATION NUMBER: NCT01286545.
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OBJECTIVE: To investigate, in a cohort of patients with ankylosing spondylitis (AS) adequately treated with infliximab, changes over time in presenteeism and the role of presenteeism relative to that of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in predicting sick leave. METHODS: Data were analyzed from 71 patients with paid work and taking a stable dose of infliximab participating in a 96-week study with 5 assessment points. Covariates included presenteeism, sick leave, time, sex, age, BASDAI, BASFI, Bath Ankylosing Spondylitis Metrology Index, and part- or full-time work. Presenteeism represented the AS impact on productivity (by visual analog scale, range 0-10, where 10 = completely unproductive). Sick leave represented the number of days absent from work due to AS in the last 6 months. A linear mixed-effects model for presenteeism, and hurdle and zero-inflated count models for sick leave were explored. RESULTS: Mean ± SD presenteeism ranged from 2.2 ± 2.2 to 3.8 ± 7.8, and sick leave occurred in 8-17% of the patients during the 6-month period. Presenteeism positively correlated with BASDAI and BASFI, but was not significantly influenced by time. The chance of incurring sick leave was affected by presenteeism but not by BASDAI and BASFI. Conditional on being absent from work, the effect of presenteeism on the length of sick leave (in days) was much stronger than BASDAI and BASFI. For presenteeism ≥5, an increase of 1 unit in presenteeism yielded an increase by 36-40% (or 2-12 days) in the length of sick leave during the following 6 months. CONCLUSION: Presenteeism, even measured by a simple visual analog scale, was an important factor to explain future sick leave.
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Presentismo/tendencias , Ausencia por Enfermedad/tendencias , Espondilitis Anquilosante/diagnóstico , Espondilitis Anquilosante/epidemiología , Adulto , Estudios de Cohortes , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Valor Predictivo de las PruebasRESUMEN
Patient assessment in axial spondyloarthritis (axSpA) is multidimensional, and monitoring of disease activity, function and radiographic progression is complex. There is no simple 'gold standard' for measuring disease activity in all individual patients, as disease activity in axSpA is the sum of many different aspects and a complexity that cannot be represented by a single variable. Limited spinal mobility is a cardinal sign of ankylosing spondylitis and loss of spinal mobility has been reported to be a prognostic factor and most often evaluated with the Bath Ankylosing Spondylitis Functional Index. Imaging of the spine and assessment of safety aspects plays an important role in the monitoring of patients with axSpA. The timeframe for collecting information regarding disease activity, function and radiographic progression are recommended on an individual basis.
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Monitoreo Fisiológico , Médula Espinal/metabolismo , Espondilitis Anquilosante/diagnóstico , Animales , Biomarcadores/metabolismo , Progresión de la Enfermedad , Humanos , Pronóstico , Radiografía , Índice de Severidad de la Enfermedad , Médula Espinal/diagnóstico por imagen , Médula Espinal/patología , Resultado del TratamientoRESUMEN
INTRODUCTION: The topic under discussion is of strong relevance to the field of spondyloarthritis (SpA) because, in addition to established biological, there are new promising compounds. The reason for the review is to put all available data together to allow for an overview on recent developments and to especially inform readers about emerging drugs, biologics and small molecules in the field of SpA. AREAS COVERED: This review on new therapies in axial and peripheral SpA comprising psoriatic arthritis (PsA) shows, that, in addition to the established anti-TNF agents infliximab, etanercept, adalimumab, golimumab, certolizumab and the first biosimilar approved in the EU, there are at least two emerging biologics in the field of SpA: ustekinumab, a compound targeting IL12/IL-23 via the p40 subunit of both cytokines works for psoriasis and PsA and probably also for Crohn's disease, and the anti-IL-17 antibody secukinumab which has also been shown to work in psoriasis, both compounds seem to also work in ankylosing spondylitis. In addition, the potential of two small molecules, apremilast a phoshodiesterase4 inhibitor and tofacitinib, a januskinase inhibitor is discussed. EXPERT OPINION: Since, in contrast to rheumatoid arthritis, the therapeutic array in SpA is currently limited to TNF-blockers, and since there is still an unmet need because some patients do not respond to anti-TNF therapy at all or they loose response, new agents with a different mechanism of action are eagerly awaited.
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Artritis Psoriásica/tratamiento farmacológico , Espondiloartritis/tratamiento farmacológico , Espondilitis Anquilosante/tratamiento farmacológico , Animales , Antirreumáticos/farmacología , Antirreumáticos/uso terapéutico , Artritis Psoriásica/fisiopatología , Diseño de Fármacos , Humanos , Factores Inmunológicos/farmacología , Factores Inmunológicos/uso terapéutico , Espondiloartritis/fisiopatología , Espondilitis Anquilosante/fisiopatología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
OBJECTIVE: The Assessment of Spondyloarthritis international Society (ASAS) classification criteria for axial spondyloarthritis (axSpA) have added nonradiographic axSpA (nr-axSpA) to the classic ankylosing spondylitis (AS) as defined by the modified New York criteria. However, some confusion remains about differences between classification and diagnosis of axSpA. Our objective was to analyze differences between classification and diagnostic criteria by discussing each feature of the classification criteria based on real cases. METHODS: The clinical features of the ASAS classification criteria were evaluated in relation to their significance for an expert diagnosis of axSpA. Twenty cases referred to our tertiary center outpatient clinic were selected because of an incorrect diagnosis of axSpA: 10 cases in which axSpA had been excluded initially because the classification criteria were not fulfilled, and 10 patients who had been previously diagnosed with axSpA because the classification criteria were fulfilled. Upon reevaluation, the former were diagnosed with axSpA while the latter had other diseases. RESULTS: All items that are part of the classification criteria show some variability related to their relevance for a diagnosis of axSpA. There are clinical features suggestive of axSpA that are not part of the classification criteria. Misinterpretation of imaging procedures contributed to false-positive results. Rarely, other diseases may mimic axSpA. CONCLUSION: Because the sensitivity and specificity of the axSpA classification criteria have been around 80% in clinical trials, some false-positive and false-negative cases were expected. It is hoped that their detailed description and discussion will help to increase the understanding of diagnosing axSpA in relation to the ASAS classification criteria.
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Espondiloartritis/clasificación , Espondiloartritis/diagnóstico , Espondilitis Anquilosante/clasificación , Espondilitis Anquilosante/diagnóstico , Humanos , Sensibilidad y EspecificidadRESUMEN
INTRODUCTION: The introduction of therapy with tumor necrosis factor antagonists (aTNF) was a cornerstone of treatment modalities in patients with ankylosing spondylitis (AS). After > 10 years of using aTNF, the introduction of aTNF therapy was a major step forward in the medical management of patients with spondyloarthritis (SpA), but there are still a number of scientific questions that have not been resolved. AREAS COVERED: This review includes both subtypes of axial spondyloarthritis (axSpA), non-radiographic axial SpA (nr-axSpA), and AS. It covers all five aTNF adalimumab, certolizumab, etanercept, golimumab, and infliximab, which are approved for patients with active AS. EXPERT OPINION: aTNF are efficacious and effective in reducing signs and symptoms of patients with axSpA. While aTNF reduce spinal inflammation, the effects on new bone formation are less clear. There may be a deceleration of radiographic progression in 4 years. The development of fatty lesions in vertebral edges seems to be relevant for that - especially when inflammation also persists. Reduction of aTNF doses seems to be possible in selected patients over time. In case of failure, switching to another aTNF works in the majority of cases. Long-term data suggest a favorable safety profile of aTNF.
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Antirreumáticos/uso terapéutico , Espondiloartritis/tratamiento farmacológico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Animales , Antirreumáticos/farmacología , Humanos , Espondiloartritis/metabolismo , Espondilitis Anquilosante/tratamiento farmacológico , Espondilitis Anquilosante/metabolismo , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
Treatment of patients suffering from active ankylosing spondylitis (AS) with TNFα blockers, has been shown to result in clinically significant improvement of signs and symptoms of the disease. Long-term extension studies with these agents have shown sustained clinical efficacy for up to 10 years in patients who continued treatment. However, only a few studies have examined whether reduction of dosage of discontinuation of anti-TNF therapy is possible. In daily clinical practice, prolongation of treatment intervals is frequently tried in patients who are in clinical remission for longer periods of time, but no data on the success of that are available. Discontinuation of treatment is usually needed in patients who want to become pregnant, and in patients with severe infections. This review summarises what is known on the topic of discontinuation of biologic treatment in patients with AS.
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Antiinflamatorios/administración & dosificación , Productos Biológicos/administración & dosificación , Espondilitis Anquilosante/tratamiento farmacológico , Antiinflamatorios/efectos adversos , Productos Biológicos/efectos adversos , Esquema de Medicación , Quimioterapia Combinada , Humanos , Selección de Paciente , Recurrencia , Inducción de Remisión , Factores de Riesgo , Índice de Severidad de la Enfermedad , Espondilitis Anquilosante/diagnóstico , Espondilitis Anquilosante/inmunología , Factores de Tiempo , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Factor de Necrosis Tumoral alfa/metabolismoRESUMEN
INTRODUCTION: Data from clinical studies on the long-term efficacy and safety of anti-tumor necrosis factor (TNF)-α therapy in patients with ankylosing spondylitis (AS) are scarce. This is the first report on continuous treatment with the TNFα fusion protein etanercept over seven years (y). METHODS: Overall, 26 patients with active AS were initially treated with etanercept 2 × 25 mg s.c./week with no concomitant disease modifying anti-rheumatic drugs (DMARDs) or steroids. The clinical response was assessed by standardized parameters. The primary outcome was the proportion of patients in the Spondyloarthritis International Society (ASAS) partial remission at seven years. AS disease activity scores (ASDAS) for status and improvement were compared to conventional outcome measures. RESULTS: Overall, 21/26 patients (81%) completed two years of treatment and 16/26 patients (62%) completed seven years. In the completer analysis, 31% patients were in ASAS partial remission at seven years, while 44% patients showed an ASDAS inactive disease status. Mean Bath AS activity index (BASDAI) scores, which were elevated at baseline (6.3 ± 0.9), showed constant improvement and remained low: 3.1 ± 2.5 at two years and 2.5 ± 2.2 at seven years, while ASDAS also improved (3.9 ± 0.7 at baseline, 1.8 ± 0.9 at two years, 1.6 ± 0.8 at seven years), all P <0.001. From the 10 dropouts, only 5 patients discontinued treatment due to adverse events. Patients who completed the study had lower baseline Bath AS function index (BASFI) scores vs. patients who discontinued. No other clinical parameter at baseline could predict any long-term outcome. CONCLUSIONS: This study confirms the clinical efficacy and safety of etanercept in patients with active AS over seven years of continuous treatment. After seven years, more than half of the initially treated patients remained on anti-TNF therapy, and one-third were in partial remission. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01289743
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Antirreumáticos/uso terapéutico , Inmunoglobulina G/uso terapéutico , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Espondilitis Anquilosante/tratamiento farmacológico , Adulto , Progresión de la Enfermedad , Etanercept , Femenino , Humanos , Masculino , Inducción de Remisión , Tiempo , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Axial spondyloarthritis (SpA) - including ankylosing spondylitis (AS) - is a frequent chronic inflammatory disease that affects mainly the axial skeleton. There is evidence that NSAIDs and tumor necrosis factor (TNF) α blockers are efficacious, but not all patients achieve remission or a major clinical response. A variety of new drug classes have been investigated during the last years for the treatment of patients with AS in whom TNF blockers have failed or are contraindicated. RECENT FINDINGS: Data for abatacept, anakinra, apremilast, bisphosphonates, rituximab, secukinumab, sulfasalazine, thalidomide and tocilizumab were found. All studies had problems with design and methodology. SUMMARY: Although some trends for efficacy were seen, there is at present insufficient evidence to support a recommendation for any of these compounds. So far, none of these new drugs has been shown to reach response rates compared to TNF-blockers.
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Antirreumáticos/uso terapéutico , Inmunosupresores/uso terapéutico , Espondilitis Anquilosante/tratamiento farmacológico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Medicina Basada en la Evidencia/métodos , Humanos , Insuficiencia del TratamientoRESUMEN
Axial spondyloarthritis, which includes ankylosing spondylitis and psoriatic spondyloarthritis, is an important subtype of the spondyloarthritides. Tumor necrosis factor (TNF) antagonists are effective therapies for this partially heterogeneous group of rheumatic diseases in terms of signs, symptoms, and functioning, but they do not seem to substantially inhibit radiographic progression, which is mainly new bone formation in ankylosing spondylitis. However, they clearly reduce inflammation, as shown by MRI. TNF blockers are also efficacious in the treatment of extraspinal features of spondyloarthritis. In addition, evidence indicates that anti-TNF therapy works well in early axial disease. Other biologics are currently being investigated, as alternatives are needed for patients who fail anti-TNF therapy.
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Terapia Biológica , Espondiloartritis/terapia , Adalimumab , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados , Antirreumáticos/uso terapéutico , Etanercept , Humanos , Inmunoglobulina G/uso terapéutico , Infliximab , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
OBJECTIVE: To evaluate the efficacy and safety of the tumor necrosis factor (TNF) antagonist adalimumab in patients with axial spondylarthritis (SpA) without radiographically defined sacroiliitis refractory to conventional treatment. METHODS: Patients with active axial SpA (n = 46) were randomized to receive placebo or adalimumab at a dosage of 40 mg subcutaneously every other week for 12 weeks, followed by an open-label extension that continued up to week 52. The diagnosis of axial SpA required the presence of 3 of 6 diagnostic criteria, including 2 of the following 3 criteria: inflammatory back pain, HLA-B27 positivity, or acute inflammation of the spine or sacroiliac joints on magnetic resonance imaging, in the absence of radiographic evidence of sacroiliitis. The primary end point was a 40% response according to the improvement criteria of the Assessment of SpondyloArthritis international Society (ASAS40). RESULTS: All 46 patients (22 receiving adalimumab and 24 receiving placebo) completed the 12-week trial; 38 patients completed the extension period to week 52. At week 12, an ASAS40 response was achieved by 54.5% of the adalimumab-treated patients, as compared with 12.5% of the placebo-treated patients (P = 0.004). After switching to adalimumab, a similar degree of efficacy was also achieved by the patients who were initially treated with placebo. Efficacy was maintained in all patients until week 52. Young age at study entry and an elevated C-reactive protein concentration were the best predictors of achieving an ASAS40 response. Serious adverse events occurred in 5 patients, none of which was related to the study drug. CONCLUSION: Adalimumab is the first TNF antagonist to demonstrate good clinical efficacy and safety in patients with axial SpA without radiographically defined sacroiliitis.