scholarly journals AB0695 SUSTAINED ASDAS-CRP REMISSION IS ASSOCIATED WITH BETTER LONG-TERM FUNCTIONAL OUTCOMES: A REAL-LIFE ANKYLOSING SPONDYLITIS COHORT STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1643.1-1643
Author(s):  
J. M. Kerber ◽  
J. D. De Mello ◽  
P. Palominos ◽  
A. A. Gasparin ◽  
F. D. A. Menegat ◽  
...  

Background:Ankylosing spondylitis (AS) leads to back pain and structural damage that may result in functional impairment1. Function is usually assessed in clinical trials conducted in developed countries, with patients receiving biological therapy2,3.Objectives:To evaluate variation in the Bath Ankylosing Functional index (BASFI) over time in a AS cohort followed in a developing country. Compare the improvement in BASFI between patients achieving or not sustained (≥12 months) ASDAS-CRP remission/low disease activity (LDA). Analyze predictors for achieving a minimum clinically important improvement (MCII) in BASFI (ΔBASFI ≤ -0.6)4.Methods:This cross-sectional analysis was conducted in a retrospective cohort. Adult patients fulfilling the New York criteria for AS and followed during at least 5 years in the Spondyloarthritis clinic were included. BASFI variation (ΔBASFI) was described as median (25th/75th). Comparison of ΔBASFI between patients fulfilling or not sustained ASDAS-CRP remisson/LDA was done using the Mann-Whitney test. Hierarchical Poisson model was used to identify predictors for achieving a MCII in BASFI.Results:69 patients were analyzed, 53.6% were men, the mean age was 48.9±11.4 years, and the mean follow-up time was 6.1±0.5 years, median (25th/75th) disease duration of 10 (5-18) years; 14.5% of the patients were on biological therapy at baseline. The median (25th/75th) ΔBASFI was low: -0.1 (-1.9 /+1.1) but 46.4% (N= 32) presented a MCII in BASFI during follow-up. Patients who achieved sustained ASDAS-CRP remission/LDA had a significant improvement in BASFI over time compared with those who did not achieve this target (p=0.026) (Figure 1). Patients with higher BASFI scores at baseline had a greater probability of achieving a MCII in BASFI (RR1.13 95%CI 1.00-1.27 p=0.047). Achieving and maintaining ASDAS-CRP remission/LDA during at least 12 months increased in 82% the probability to obtain a MCII in BASFI (RR 1.82 95% CI 1.14-2.91, p=0.012). Conclusion: Patients achieving sustained ASDAS-CRP remission/LDA had better functional outcomes over time compared to those not achieving this target. Higher BASFI scores at baseline and sustained ASDAS remission/LDA were predictors of a MCII in BASFI.Figure 1.Comparison of ΔBASFI between patients who achieved or not sustained ASDASCRP remission/LDA.References:[1] Madsen OR: Stability of fatigue, pain, patient global assessment and the Bath Ankylosing Spondylitis Functional Index (BASFI) in spondyloarthropathy patients with stable disease according to the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Rheumatol Int. 2018;38(3):425-432.[2] Baraliakos X, Kivitz AJ, et al: Long-term effects of interleukin-17A inhibition with secukinumab in active ankylosing spondylitis: 3-year efficacy and safety results from an extension of the Phase 3 MEASURE 1 trial. Clin Exp Rheumatol. 2018; 36(1):50-55[3] Deodhar A, Reveille JD, et al: Safety and Efficacy of Golimumab Administered Intravenously in Adults with Ankylosing Spondylitis: Results through Week 28 of the GO-ALIVE Study. J Rheumatol. 2018; 45(3):341-348[4] Kviatkovsky MJ, Ramiro S, Landewé R, et al: The Minimum Clinically Important Improvement in Patient-acceptable Symptom State in the BASDAI and BASFI for Patients with Ankylosing Spondylitis. J Rheumatol 2016; 43(9): 11680-1686.Disclosure of Interests:Juliana Maria Kerber Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Juliana Dias de Mello Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Penelope Palominos Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Andrese Aline Gasparin Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Franciele de Almeida Menegat Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Claiton Viegas Brenol Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Charles Kohem Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul).

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1727.2-1728
Author(s):  
L. Vargas Cruz ◽  
J. Boechat Farani ◽  
J. Rabello Costa ◽  
F. Menegat ◽  
J. V. Andrade Águas ◽  
...  

Background:Patients with psoriatic arthritis (PsA) experience substantial functional impairment, which impacts on health-related quality of life.1Evidence from randomized clinical trials (RCTs) suggests better patient-reported functional outcomes when lower disease activity is achieved.2,3,4Objectives:To evaluate the impact of achieving DAPSA remission (REM) or low disease activity (LDA) on long term function measured by HAQ-DI. To verify predictors of achieving a minimum clinically important difference (MCID) in HAQ-DI (≤ -0.35).Methods:This is a longitudinal analysis of a real-life retrospective cohort. Inclusion criteria were adult patients fulfilling CASPAR criteria for PsA with at least 4 years of follow-up in the PsA Clinic. Demographic and clinical data were extracted from electronic medical records. Comparison of HAQ-DI variation between patients with DAPSA REM/LDA and those with moderate/high disease activity was performed using generalized estimating equation (GEE), adjusted by Bonferroni test. Correlation between HAQ-DI and DAPSA was analyzed by Spearman correlation method. A multivariate hierarchical regression model was applied in order to evaluate predictors of achieving a MCID in HAQ-DI scores.Results:Seventy-three patients were included in the analysis, of which 58.9% were female, with a median (25/75th) of 8 (3-15) years since PsA diagnosis and a mean follow up time of 6.2±1.2 years. In total, 37% of patients (N=27) presented a MCID in HAQ-DI during the follow-up. Function measured by HAQ-DI was determined by PsA disease activity measured by DAPSA (interaction test: p <0.0001) (Figure 1). A moderate and statistically significant correlation between ΔDAPSA and ΔHAQ-DI was observed (rs= 0.60; p<0.001) (Figure 2), demonstrating that a decrease in PsA disease activity was associated to improvement in function. Only patients in DAPSA REM demonstrated a constant declining in HAQ-DI scores during the 6 years of follow-up (Figure 1). White ethnicity and older age at baseline were predictors for not achieving MCID in HAQ-DI (RR 0.33 95% CI 0.16-0.67, p=0.002 and RR 0.96 95% CI 0.93-0.98, p<0.0001, respectively), while higher scores of HAQ-DI at baseline were predictors of achieving a MCID (RR 1.71 95%CI 1.12-2.60, p=0.013).Figure 1.Variation in HAQ-DI according to PsA disease activity measured by DAPSAFigure 2.Correlation between changes in PsA disease activity (ΔDAPSA) and changes in functional indices (ΔHAQ-DI) over three years of follow-upConclusion:In PsA, patients who maintained DAPSA REM/LDA over time had better long term functional outcomes. Higher HAQ-DI scores at baseline, non-white ethnicity and younger age were predictors for achieving a clinical significant improvement in HAQ-DI.References:[1]Mease P et al. Semin Arthritis Rheum. 2018 Dec;48(3):436-448.[2]Coates, LC et al. The Lancet. 2015 Dec; 386, 19-26.[3]Aletaha D et al. Ann Rheum Dis. 2017;76(2):418-421.[4]Kavanaugh A et al. Annals rheum Dis 2014; 73: 1689-94.Median HAQ-DIFollow-up in yearsDisclosure of Interests:Larissa Vargas Cruz: None declared, Júlia Boechat Farani: None declared, Júlia Rabello Costa: None declared, Franciele Menegat: None declared, João Victor Andrade Águas: None declared, Bruna Ruschel: None declared, Andrese Aline Gasparin: None declared, Claiton Brenol: None declared, Charles Kohem Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul)., Penelope Palominos Grant/research support from: This work was sponsored by the regional society of rheumatology (Sociedade de Reumatologia do Rio Grande do Sul).


2011 ◽  
Vol 5 (4) ◽  
pp. 916
Author(s):  
Aldenir Damião Araújo ◽  
Cleci Schmidt Rosanelli ◽  
Marli Maria Loro ◽  
Eniva Miladi Fernandes Stumm ◽  
Adriane Bernat Kolankiewicz

ABSTRACT Objective: to know the profile and complications experienced by oncological patients with long-term catheter, who were receiving chemotherapy treatment. Method: a quantitative, descriptive, retrospective, and documental research. The data were collected in July and August 2009, in the records "files of the catheters" from patients attended at a Center for High Complexity in Oncology at a hospital in the Northwest of Rio Grande do Sul. The project was approved by the Ethics Committee in Research of Unijuí (134/2009). Results: from 147 registers, 66.7% were female, the mean age was 44,06 years-old, the general services occupation represented 38.8%. The breast cancer in women is the disease with highest percentages (32.7%), the mean permanence of first catheter is 442,47 days and the second is 426,50 days. The complications with first catheter were: obstructions (4.8%), edemas (2.0%), infections (2.0%), disconnections, and hematomas (2.0%). With implantation of the second catheter, 1.4% of patient had obstructions and 0.7% of infection. Conclusion: nurses need knowledge and abilities on the handling of long-term catheter, with the objective of minimizing complications arising their use. Descriptors: oncology; chemotherapy; central venous catheterization; indwelling catheters.RESUMOObjetivo: conhecer o perfil e as complicações apresentadas por pacientes oncológicos, com cateter de longa permanência, em tratamento quimioterápico. Método: pesquisa quantitativa, descritiva, documental e retrospectiva. Os dados foram coletados em julho e agosto de 2009, nos registros “arquivos dos cateteres” de pacientes assistidos em um Centro de Alta Complexidade em Oncologia de um hospital do Noroeste do estado do Rio Grande do Sul. Obteve-se aprovação do Comitê de Ética em Pesquisa da Unijuí (134/2009). Resultados: dos 147 registros, 66,7% são do sexo feminino, a média de idade é de 44,06 anos, a ocupação dos serviços gerais é de 38,8%. A neoplasia da mama feminina é a doença com percentual mais elevado (32,7%), a média de permanência do primeiro cateter é de 442,47 dias e do segundo cateter é de 426,50 dias. As complicações com o primeiro cateter foram: obstruções (4,8%), edema (2,0%) infecção (2,0%), desconexão e hematoma (2,0%). Com a implantação do segundo cateter, 1,4% dos pacientes tiveram obstrução e 0,7%, infecção. Conclusão: o enfermeiro necessita ter conhecimentos e habilidades acerca do manuseio do cateter de longa permanência, com o intuito de minimizar complicações decorrentes de seu uso. Descritores: oncologia; quimioterapia; cateterismo venoso central; cateteres de demora.RESUMENObjetivo: conocer el perfil y las complicaciones presentadas por pacientes oncológicos, con catéter de larga permanencia, sometidos a quimioterapia. Método: pesquisa cuantitativa, descriptiva, documental y retrospectiva. Los datos fueron colectados en julio y agosto de 2009, en los registros “archivos de los catéteres” de pacientes tratados en un Centro de Alta Complejidad en Oncología, de un hospital del Noroeste del estado del Rio Grande do Sul. Se obtuvo aprobación del Comité de Ética en Pesquisa de la Unijuí (134/2009). Resultados: de los 147 registros, 66,7% son de mujeres, la media de edad es de 44,06 años, la ocupación de los servicios generales es de 38,8%. La neoplasia de mama femenina es la enfermedad con mayor porcentaje (32,7%), la media de permanencia del primer catéter es de 442,47 días y del segundo, 426,50 días. Las complicaciones con el primer catéter fueron: obstrucciones (4,8%), edema (2,0%), infección (2,0%), desconexión y hematoma (2,0%). Con la implantación del segundo catéter, 1,4% de los pacientes tuvieron obstrucción y 0,7%, infección. Conclusión: el enfermero debe tener conocimientos y habilidades en el manoseo del catéter de larga permanencia, con intención de minimizar complicaciones provenientes del uso de los mismos. Descriptores: oncología; quimioterapia; cateterismo venoso central; catéteres de retraso.


2015 ◽  
Vol 35 (4) ◽  
pp. 769-777 ◽  
Author(s):  
Izabele B. Kruel ◽  
Monica C. Meschiatti ◽  
Gabriel C. Blain ◽  
Ana M. H. de Ávila

ABSTRACT Changes in the frequency of occurrence of extreme weather events have been pointed out as a likely impact of global warming. In this context, this study aimed to detect climate change in series of extreme minimum and maximum air temperature of Pelotas, State of Rio Grande do Sul, (1896 - 2011) and its influence on the probability of occurrence of these variables. We used the general extreme value distribution (GEV) in its stationary and non-stationary forms. In the latter case, GEV parameters are variable over time. On the basis of goodness-of-fit tests and of the maximum likelihood method, the GEV model in which the location parameter increases over time presents the best fit of the daily minimum air temperature series. Such result describes a significant increase in the mean values of this variable, which indicates a potential reduction in the frequency of frosts. The daily maximum air temperature series is also described by a non-stationary model, whose location parameter decreases over time, and the scale parameter related to sample variance rises between the beginning and end of the series. This result indicates a drop in the mean of daily maximum air temperature values and increased dispersion of the sample data.


2017 ◽  
Vol 16 (1) ◽  
pp. 198-203 ◽  
Author(s):  
Jamie Young ◽  
Bhasker Amatya ◽  
Mary P. Galea ◽  
Fary Khan

AbstractBackground and purposePain is a common symptom associated with multiple sclerosis (MS), and has lasting effects on an individual’s functional capacity and quality of life. A wide range of prevalence rates of pain (between 23% and 90%)have been reported in MS and this is mainly due to the methodological differences amongst the studies such as variability in patient sources, method of sampling and the definition of pain used. Chronic pain in MS, defined as pain lasting for greater than 3–6 months, can have a significant impact on their biopsychosocial health, including negative impact on activities of daily living, relationships and social participation. The long-term course of MS-related pain and its impact in an Australian cohort over a 7-year period has been investigated earlier. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period. The aim of this longitudinal study was to describe the impact of chronic pain, pain-related disability and carer burden in persons with MS over a 10-year period.MethodsThis was a prospective longitudinal study conducted at the Rehabilitation Department of Royal Melbourne Hospital (RMH), a tertiary referral hospital in Victoria and Australia. The source of participants was from the RMH MS database and contains detailed MS patient information including demographic data, diagnosis details (using McDonald’s criteria), pain characteristics. Structured face-face interviews and validated measures were used, which include the visual analogue scale (VAS); chronic pain grade (CPG); the assessment of quality of life (AQoL) and the carer strain index (CSI). The mean age of the participants (n = 70) was 55.3 years and majority (70%) were female.ResultsThe mean age of the participants (n = 70) was 55.3 years and majority (70%) were female. The findings show that over time (10 years), participants report having greater bilateral bodily pain and greater description of pain as ‘worse as it could be’. Pain types were similar to 7-years follow-up but remained higher than baseline. There was a significant deterioration in quality of life in those with more severe CPG over time. Almost half of the participants 31 (44%) required care either from a private carer, institution or from a family member. Although fear of taking medications and side effects were common barriers to treatment for pain, there was an increase in the use of pharmacological treatment over time and an increase in the use of healthcare services, mainly neurologists and general practitioners.ConclusionsThe pain measures reported by the participants were similar to those at the 7-year follow-up except there was a greater representation of bilateral pain locations (limb, trunk and facial pain) compared to baseline and 7-year follow-up. At 10-year follow-up, more participants used medications compared tc 7-year follow-up and there was an increase in the use of health professionals at the 10-year follow-up At the 10-year follow up QoL of the participants deteriorated significantly and more participants had progressed to higher CPGIII and CPGIV. This study demonstrates that chronic pain is a significant issue over time in MS, with clinical and health implications, impact on quality of life, disability and healthcare utilization.ImplicationsGreater awareness of chronic pain in pwMS, cognitive classifications and an interdisciplinary approach is required to improve long-term patient outcomes and well-being.Crown Copyright © 2017 Published by Elsevier B.V. on behalf of Scandinavian Association for the Study of Pain. All rights reserved.


Author(s):  
Kaj T. A. Lambers ◽  
Jari Dahmen ◽  
J. Nienke Altink ◽  
Mikel L. Reilingh ◽  
Christiaan J. A. van Bergen ◽  
...  

Abstract Purpose Although bone marrow stimulation (BMS) as a treatment for osteochondral lesions of the talus (OCLT) shows high rates of sport resumption at short-term follow-up, it is unclear whether the sports activity is still possible at longer follow-up. The purpose of this study was, therefore, to evaluate sports activity after arthroscopic BMS at long-term follow-up. Methods Sixty patients included in a previously published randomized-controlled trial were analyzed in the present study. All patients had undergone arthroscopic debridement and BMS for OCLT. Return to sports, level, and type were assessed in the first year post-operative and at final follow-up. Secondary outcome measures were assessed by standardized questionnaires with use of numeric rating scales for pain and satisfaction and the Foot and Ankle Outcome Score (FAOS). Results The mean follow-up was 6.4 years (SD ± 1.1 years). The mean level of activity measured with the AAS was 6.2 pre-injury and 3.4 post-injury. It increased to 5.2 at 1 year after surgery and was 5.8 at final follow-up. At final follow-up, 54 patients (90%) participated in 16 different sports. Thirty-three patients (53%) indicated they returned to play sport at their pre-injury level. Twenty patients (33%) were not able to obtain their pre-injury level of sport because of ankle problems and eight other patients (13%) because of other reasons. Mean NRS for pain during rest was 2.7 pre-operative, 1.1 at 1 year, and 1.0 at final follow-up. Mean NRS during activity changed from 7.9 to 3.7 to 4.4, respectively. The FAOS scores improved at 1 year follow-up, but all subscores significantly decreased at final follow-up. Conclusion At long-term follow-up (mean 6.4 years) after BMS for OCLT, 90% of patients still participate in sports activities, of whom 53% at pre-injury level. The AAS of the patients participating in sports remains similar pre-injury and post-operatively at final follow-up. A decrease over time in clinical outcomes was, however, seen when the follow-up scores at 1 year post-operatively were compared with the final follow-up. Level of evidence Level II.


2021 ◽  
Vol 8 ◽  
Author(s):  
Alexandra Gruber-Wackernagel ◽  
Tanja Schug ◽  
Thomas Graier ◽  
Franz J. Legat ◽  
Hanna Rinner ◽  
...  

Background: Little is known about the long-term course of polymorphic light eruption (PLE).Objective: To predict disease course, a questionnaire was sent to patients whose PLE had been diagnosed between March 1990 and December 2018 and documented in the Austrian Cooperative Registry for Photodermatoses.Methods: In January 2019, 205 PLE patients were contacted by mail and asked to complete a questionnaire on their disease course, including whether the skin's sun sensitivity had normalized (i.e., PLE symptoms had disappeared), improved, stayed the same, or worsened over time. Patients who reported normalization of sun sensitivity were asked to report when it had occurred.Results: Ninety-seven patients (79 females, 18 males) returned a completed questionnaire. The mean (range) duration of follow-up from PLE onset was 29.6 (17–54) years for females and 29.4 (16–47) years for males. The disease disappeared in 32 (41%) females after 17.4 (2–41) years and in 4 (24%) males after 11.8 (5–26) years. Twenty-nine (37%) females and 6 (35%) males reported improvement of symptoms over time; 15 females (19%) and 7 males (41%) reported no change; and 3 females (4%) and no males reported worsening of symptoms. Kaplan-Meier analysis revealed that after 20 years 74% (95%CI, 64–82%) of patients still suffered from PLE. PLE lesion persistence (&gt;1 week) tended to predict a prolonged course of PLE.Conclusions: PLE usually takes a long-term course over many years though in most patients its symptoms improve or disappear over time. How improvement relates to the pathophysiology of the disease remains to be determined.


2019 ◽  
Vol 42 (6) ◽  
pp. 581-586 ◽  
Author(s):  
Christina L Hvaring ◽  
Kari Birkeland

Summary Objectives The decision to preserve or to extract a deciduous tooth without a successor hinges upon whether it can be expected to be stable over time. This study aimed to record the number and location of deciduous teeth and to examine the condition of deciduous canines and molars in a group of patients with severe hypodontia, both at baseline and at follow-up. Material and methods A total of 50 patients participated in a follow-up study. The average age was 13.9 years (range 7–25 years) at baseline and 25.6 years (range 18–38 years) at follow-up. Of the 50 subjects, 44 had at least one persisting deciduous tooth at follow-up and 42 had at least one deciduous canine or molar at baseline. The presence of persisting deciduous teeth was identified on panoramic radiographs. Deciduous canines and second molars were classified as good or poor based on infraocclusion, root resorption, and restorations. Results The mean number of persisting deciduous teeth per patient was 6.3 (range 1–16) at baseline and 2.6 (range 0–9) at follow-up. The tooth types with the highest tendency to remain were canines and second molars, and in particular canines in the mandible. Among the 42 participants with a deciduous canine or molar, 183 teeth were present at baseline, of which 112 were classified as good. At follow-up, 86 (77 per cent) of these were still present, with 65 (58 per cent) classified as good. The number of teeth classified as poor due to infraocclusion decreased much more from baseline to follow-up than those classified as poor due to root resorptions and restorations, indicating that infraoccluded teeth were lost during the observation period. Conclusions Preserving deciduous canines and molars in good condition is often a dependable choice. Early infraocclusion is detrimental to the prognosis and often leads to tooth loss. Teeth with short roots proved to be more stable over time.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 5881-5881
Author(s):  
Dave Nellesen ◽  
Qayyim Said ◽  
Nina Shak ◽  
Cody Patton ◽  
Sedge Lucas ◽  
...  

Abstract Introduction: Chronic immune thrombocytopenia (cITP) is an autoimmune disorder defined by low platelet count (<100 x 109/L) lasting ≥12 months in the absence of other causes of thrombocytopenia. Splenectomy is an option for patients with cITP who fail to respond to oral corticosteroids and/or intravenous immunoglobulin or relapse after treatment is discontinued. A systematic literature review (SLR) conducted in 2004 (Kojouri et al) identified articles describing outcomes associated with splenectomy in patients with cITP. The objective of this study was to update this SLR with a focus on contemporary data on long-term outcomes (≥12 months of follow-up). Methods: MEDLINE, Embase, Cochrane CENTRAL and recent congresses were searched in June 2018. Results were screened against predefined criteria by two independent researchers. Included studies assessed patients with cITP (N≥15) who underwent splenectomy; studies of patients with secondary ITP, newly diagnosed ITP, and/or persistent ITP were excluded unless separate outcomes were reported for cITP subgroups. Outcomes of interest were clinical efficacy (response and relapse rates), safety (rates of complications), mortality, and health-related quality of life (HRQoL). Prospective or retrospective clinical studies or real-world study types were included. English-language studies published during or after 2000 were included, with no geographic restrictions. Results: The literature search identified 3140 records for title-abstract screening. Of these, 159 full-text studies were evaluated and 108 were included in the analysis. Most studies (93) were retrospective. Fifteen prospective studies (9 interventional, 6 observational) but no randomized controlled trials were identified. Nine studies were comparative (all retrospective): splenectomy vs rituximab (3), splenectomy vs rituximab vs romiplostim (1), and splenectomy vs non-splenectomy (5). Reports of the long-term efficacy of splenectomy varied widely, with multiple definitions of response and remission across the heterogeneous study types. Among 40 studies, the mean complete response (CR) rate within 12 months of surgery was 77% (median: 81%; range: 26-97%). Relapse rates varied widely, ranging from 0-94% among 47 studies with ≥12 months of follow up. Five of 7 studies reporting remission rates at multiple time points at ≥1 year noted a decrease in clinical remission over time. Mortality generally increased with length of follow up: in studies with ≤1 month of follow-up (28 studies) the mean mortality rate was 1% (range: 0-5%), while in studies with 1-5 years of follow-up (20 studies) and ≥5 years of follow-up (15 studies), the mean mortality rate was 2% (range: 0-17%) and 11% (range: 0-30%), respectively. Four studies reported that long-term response rates were higher with splenectomy than rituximab; all other efficacy comparisons were inconclusive. Although 11 of 15 prospective studies and 61 of 93 retrospective studies reported some safety information, there were very limited data on the long-term safety of splenectomy. Commonly reported complications were bleeding (mean: 14%; median: 12% range: 0-50%; 22 studies), infections (mean: 8%; median: 4% range: 0-33%; 38 studies), venous thromboembolism (VTE) (mean: 5%; median: 3% range: 0-21%; 27 studies) and sepsis/septic shock (mean: 2%; median: 0%; range: 0-11%; 18 studies). Rates of postoperative complications (≤30 days) ranged from 3-50% (mean: 13%; 31 studies), and 2 studies suggested that older age may be associated with higher rates of postoperative complications. HRQoL data were rarely reported (3 studies). Rates of remission, relapse, and infections for studies reporting at least 1 of these outcomes at 1 or more discrete time points are shown in Figure 1. Conclusions: Although more than 100 studies reported long-term outcomes for patients with cITP treated with splenectomy, available evidence on the durability of response and long term safety are limited. In general, most measures of efficacy declined over time, while complications (infections, bleeding, VTE) and mortality increased over time. The extent to which the outcomes for splenectomy differ from currently available treatments is unclear. Additional data are needed to understand the long-term benefits and risks of splenectomy in patients with cITP. Disclosures Nellesen: Analysis Group, Inc.: Employment; Novartis Pharmaceuticals Corporation: Consultancy. Said:Novartis: Employment. Shak:Analysis Group, Inc.: Employment; Novartis Pharmaceuticals Corporation: Consultancy. Patton:Novartis Pharmaceuticals Corporation: Consultancy; Analysis Group, Inc.: Employment. Lucas:Novartis Pharmaceuticals Corporation: Consultancy; Analysis Group, Inc.: Employment. Graves:Novartis: Employment. Nezami:Novartis Pharmaceuticals: Employment. Cuker:Kedrion: Membership on an entity's Board of Directors or advisory committees; Spark Therapeutics: Research Funding; Synergy: Consultancy; Genzyme: Consultancy.


Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Roy Fleischmann ◽  
Carlo Selmi ◽  
Miguel Angel Gonzalez-Gay ◽  
Hubert van Hoogstraten ◽  
Owen Hagino ◽  
...  

Abstract Background This post hoc analysis assessed changes in oral glucocorticoid (OGC) use over time in patients receiving sarilumab 200 mg (dose reduction to 150 mg for laboratory abnormalities or per investigator’s discretion) every 2 weeks (q2w) plus conventional synthetic disease-modifying antirheumatic drugs (csDMARD) in EXTEND (NCT01146652), a long-term, open-label extension (OLE) study of sarilumab in RA. Methods Patients who had completed placebo-controlled Phase 3 studies of sarilumab +csDMARD (NCT01061736 and NCT01709578) and received sarilumab in EXTEND were included. Reported total daily OGC doses were converted to prednisone equivalent daily doses (PED). Patients were grouped by PED dose at enrollment into the OLE: 0-&lt;5, 5-&lt;10, and ≥10 mg/day (PED &lt;1 mg/day imputed to 0). PED doses were analyzed over 12-week intervals to Week 216. Change from baseline for average PED was tested (Wilcoxon-Pratt-Lehman). Results In total, 891/1353 patients (65.9%) had ≥1 record of OGC use. Of these, 137 (15.4%) received baseline PED of 0-&lt;5 mg/day, 515 (57.8%) 5-&lt;10 mg/day, and 239 (26.8%) ≥10 mg/day. Mean (±SD) PED was 6.3 (±3.1) mg/day at baseline and decreased over time (21.3% mean reduction at 4 years: nominal p &lt; 0.0001). By Weeks 49-60, 660/776 patients (85.1%) had stable PED, 90/776 patients (11.6%) had decreased PED, and 26/776 (3.4%) had increased PED. This difference increased during follow-up: at Weeks 205-216, 109/236 patients (46.2%) had decreased PED and 18/236 (7.6%) had increased PED. Patients with PED ≥5 mg/day were more likely than patients with PED &lt;5 mg/day to decrease their dose. Efficacy (CDAI and DAS28-CRP) was maintained with sarilumab irrespective of OGC tapering. Conclusion Long-term RA treatment with sarilumab was associated with sustained efficacy and decreased OGC dose. The proportion of patients who reduced their OGC dose increased with time and reductions were more common among patients with baseline PED ≥5 mg/day. Disclosures R. Fleischmann: Grants/research support; AbbVie, Acea, Akros, Amgen, Astra Zeneca, Bristol-Myers Squibb, Celgene, Celltrion, Centrexion, Eli Lilly, EMD Serono, Genentech, Glaxo Smith Kline, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron, Resolve, Roche. C. Selmi: Grants/research support; AbbVie, Alfa-Sigma, Biogen, Bristol-Myers Squibb, Celgene, Eli Lilly, Glaxo Smith Kline, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi-Genzyme, and UCB. M. Gonzalez-Gay: Grants/research support; AbbVie, Celgene, Eli Lilly, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Roche, Sanofi, and Sobi. H. van Hoogstraten: Corporate appointments; Employee of Sanofi. Shareholder/stock ownership; Sanofi. O. Hagino: Corporate appointments; Employee of Sanofi. Shareholder/stock ownership; Sanofi. T. Rajput: Corporate appointments; Employee of Cytel. G. St John: Corporate appointments; Employee of Regeneron Pharmacueticals Inc. Shareholder/stock ownership; Regeneron Pharmacueticals Inc. F. Buttgereit: Grants/research support; Medac, Pfizer, Roche/Chugai, and Sanofi-Genzyme. M.C. Genovese: Grants/research support; AbbVie, Astellas, Eli Lilly, EMD Serono, Galapagos, Genentech/Roche, Gilead Sciences, Inc., GlaxoSmithKline, Novartis, Pfizer, RPharm, Sanofi Genzyme, and Vertex.


2019 ◽  
Vol 24 (5) ◽  
pp. 549-557
Author(s):  
Malia McAvoy ◽  
Heather J. McCrea ◽  
Vamsidhar Chavakula ◽  
Hoon Choi ◽  
Wenya Linda Bi ◽  
...  

OBJECTIVEFew studies describe long-term functional outcomes of pediatric patients who have undergone lumbar microdiscectomy (LMD) because of the rarity of pediatric disc herniation and the short follow-up periods. The authors analyzed risk factors, clinical presentation, complications, and functional outcomes of a single-institution series of LMD patients over a 19-year period.METHODSA retrospective case series was conducted of pediatric LMD patients at a large pediatric academic hospital from 1998 to 2017. The authors examined premorbid risk factors, clinical presentation, physical examination findings, type and duration of conservative management, indications for surgical intervention, complications, and postoperative outcomes.RESULTSOver the 19-year study period, 199 patients underwent LMD at the authors’ institution. The mean age at presentation was 16.0 years (range 12–18 years), and 55.8% were female. Of these patients, 70.9% participated in competitive sports, and among those who did not play sports, 65.0% had a body mass index greater than 25 kg/m2. Prior to surgery, conservative management had failed in 98.0% of the patients. Only 3 patients (1.5%) presented with cauda equina syndrome requiring emergent microdiscectomy. Complications included 4 cases of postoperative CSF leak (2.0%), 1 case of a noted intraoperative CSF leak, and 3 cases of wound infection (1.5%). At the first postoperative follow-up appointment, minimal or no pain was reported by 93.3% of patients. The mean time to return to sports was 9.8 weeks. During a mean follow-up duration of 8.2 years, 72.9% of patients did not present again after routine postoperative appointments. The total risk of reoperation was a rate of 7.5% (3.5% of patients underwent reoperation for the same level; 4.5% underwent adjacent-level decompression, and one patient [0.5%] ultimately underwent a fusion).CONCLUSIONSMicrodiscectomy is a safe and effective treatment for long-term relief of pain and return to daily activities among pediatric patients with symptomatic lumbar disc disease in whom conservative management has failed.


Sign in / Sign up

Export Citation Format

Share Document