Brucellosis is a zoonosis with non-specific clinical symptoms involving multiple systems and organs. Its prevalence is low in most of EU countries, which can lead to the difficulties in laboratory and clinical diagnostic. Due to its relationship to the Ochrobactrum spp., it may be misclassified in rapid identification systems. We present a case of a 13-year-old immunocompetent girl who was examined several times for fever, fatigue, night sweats and weight loss; laboratory results showed mildly elevated C-reactive protein, anaemia and leukopenia. Four weeks before the onset of symptoms, she had been on a family holiday in Egypt. Given her symptoms, a haemato-oncological or autoimmune disease was considered more likely. The diagnosis of Brucella spondylitis was made after 4 months. The main reasons for this delay were as follows: low specificity of clinical symptoms, delay in completing the travel history, inconclusive initial serological results and misidentification of the blood culture isolate as Ochrobactrum sp. Even in countries with a low incidence of brucellosis, it is essential to educate healthcare professionals about the disease. Low specificity of symptoms and limited experience of laboratory staff may lead to late diagnosis with risk of complications and poor outcome. If Ochrobactrum spp. is detected in clinical specimens by rapid identification, careful re-evaluation must follow and all measures to prevent laboratory-acquired infections must be taken until Brucella spp. is unequivocally excluded.
- MeSH
- Bacteremia * diagnosis microbiology MeSH
- Brucella isolation & purification classification MeSH
- Brucellosis * diagnosis microbiology MeSH
- Diagnostic Errors * MeSH
- Gram-Negative Bacterial Infections diagnosis microbiology MeSH
- Fever * microbiology etiology MeSH
- Humans MeSH
- Adolescent MeSH
- Ochrobactrum * genetics isolation & purification MeSH
- Spondylitis microbiology diagnosis MeSH
- Check Tag
- Humans MeSH
- Adolescent MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Case Reports MeSH
- Geographicals
- Egypt MeSH
BACKGROUND CONTEXT: Spondylodiscitis management presents significant clinical challenges, particularly in critically ill patients, where the risks and benefits of surgical intervention must be carefully balanced. The optimal timing of surgery in this context remains a subject of debate. PURPOSE: This study aims to evaluate the effectiveness of early surgery versus delayed surgery or conservative management in critically ill patients with de novo pyogenic spondylodiscitis. STUDY DESIGN/SETTING: This is an international, multicenter retrospective cohort study involving 24 centers, primarily in Europe. PATIENT SAMPLE: The study included 192 critically ill patients (65.63% male) with a median age of 69 years, all severely affected by pyogenic spondylodiscitis characterized by an initial CRP level >200 mg/l or the presence of two out of four Systemic Inflammatory Response Syndrome criteria upon admission. OUTCOME MEASURES: The primary outcome was 30-day mortality. Secondary outcomes included length of ICU stay, length of hospital stay, and relapse rates of spondylodiscitis. METHODS: Patients were divided into three groups: early surgery (within three days of admission), delayed surgery (after three days of admission), and conservative therapy. Propensity score matching and multivariate regression analyses were performed to adjust for baseline differences and assess the impact of treatment modalities on mortality and other clinical outcomes. RESULTS: Delayed surgery was associated with significantly lower 30-day mortality (4.05%) compared to early surgery (27.85%) and conservative therapy (27.78%) (p<.001). Delayed surgery also resulted in shorter hospital stays (42.76 days) compared to conservative therapy (55.53 days) and early surgery (26.33 days) (p<.001), and shorter ICU stays (4.52 days) compared to conservative therapy (16.48 days) and early surgery (7.92 days) (p<.001). The optimal window for surgery, minimizing mortality, was identified as ten to fourteen days postadmission (p=.02). Risk factors for increased mortality included age (p<.05), multiple organ failure (p<.05), and vertebral body destruction (p<.05), whereas delayed surgery (p<.05) and the presence of an epidural abscess were associated with reduced mortality (p<.05). CONCLUSIONS: Delayed surgery, optimally between 10 to 14 days postadmission, was associated with lower mortality in critically ill spondylodiscitis patients. These findings highlight the potential benefits of considering surgical timing to improve patient outcomes.
- MeSH
- Anti-Bacterial Agents therapeutic use MeSH
- Length of Stay MeSH
- Discitis * therapy mortality surgery microbiology MeSH
- Conservative Treatment MeSH
- Critical Illness MeSH
- Middle Aged MeSH
- Humans MeSH
- Retrospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
OBJECTIVES: In axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) patients initiating secukinumab, we aimed to assess retention rates and proportions of patients achieving remission and low disease activity (LDA), according to disease activity measures and patient-reported outcomes at 24 and 48 months. PATIENTS AND METHODS: Data on patients with axSpA and PsA who initiated secukinumab treatment were pooled from 13 European registries. Analyses were performed overall and stratified according to the number of previous biologic/targeted synthetic Disease-Modifying Antirheumatic Drugs (b/tsDMARDs, 0/1/≥2). Kaplan-Meier plots and Cox regression analyses were performed to assess and compare secukinumab retention rates. Comparisons of remission and LDA rates were performed by logistic regression analyses. RESULTS: The overall 24-/48-month secukinumab retention rates were 61%/51% in 767 axSpA patients, and 64%/49% in 975 PsA patients, respectively. Compared to b/tsDMARD naïve patients, a higher risk of withdrawal from secukinumab was found for those with≥2 prior b/tsDMARDs in axSpA and PsA, and 1 prior b/tsDMARD in axSpA. Generally, remission and LDA rates were numerically higher in b/tsDMARD naïve patients. After adjustment for confounders, statistically significantly higher remission and LDA rates were found for b/tsDMARD naïve patients compared to patients with≥ 2 prior b/tsDMARDs at 24 months in axSpA and PsA. CONCLUSION: This large European real-world study demonstrates that 4-year secukinumab retention rates were approximately 50% in both axSpA and PsA. b/tsDMARD naïve patients had higher retention, remission and LDA rates than patients with prior b/tsDMARD exposure.
- MeSH
- Antirheumatic Agents * therapeutic use MeSH
- Axial Spondyloarthritis * drug therapy diagnosis MeSH
- Time Factors MeSH
- Adult MeSH
- Patient Reported Outcome Measures MeSH
- Antibodies, Monoclonal, Humanized * therapeutic use MeSH
- Remission Induction MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Arthritis, Psoriatic * drug therapy diagnosis MeSH
- Registries MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
- Geographicals
- Europe MeSH
OBJECTIVE: Our goal was to assess the efficacy and safety of intravenous (IV) secukinumab for the treatment of adults with active axial spondyloarthritis (axSpA) in INVIGORATE-1. METHODS: INVIGORATE-1 (NCT04156620) was a randomized, double-blind, parallel-group, phase 3 trial in patients with active axSpA (either radiographic or nonradiographic). Patients were randomized one to one to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks) or IV placebo for 16 weeks. After week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg every four weeks), and patients randomized to secukinumab continued treatment through week 52. The primary endpoint was the Assessment of SpondyloArthritis International Society (ASAS40) response at week 16. Safety was evaluated through week 60. RESULTS: Among patients initially randomized to IV secukinumab (n = 264) or placebo (n = 262), 86.0% and 88.9% completed the entire 60-week study period, respectively. A higher proportion of patients receiving secukinumab versus placebo met the primary endpoint (ASAS40 response) at week 16 (40.9% vs 22.9%; P < 0.0001). By week 24, patients who switched from placebo to secukinumab at week 16 achieved ASAS40 response rates comparable to those in patients originally randomized to secukinumab. All secondary efficacy endpoints were met at week 16, and responses were sustained through week 52. No new or unexpected safety signals were observed with IV secukinumab. CONCLUSION: IV secukinumab was effective for the treatment of adults with active axSpA over 52 weeks. The safety profile was consistent with that in previous reports on subcutaneous secukinumab.
- MeSH
- Antirheumatic Agents administration & dosage therapeutic use adverse effects MeSH
- Axial Spondyloarthritis * drug therapy MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Antibodies, Monoclonal, Humanized * administration & dosage therapeutic use adverse effects MeSH
- Administration, Intravenous MeSH
- Middle Aged MeSH
- Humans MeSH
- Antibodies, Monoclonal administration & dosage therapeutic use adverse effects MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Randomized Controlled Trial MeSH
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of intravenous (IV) secukinumab in patients with active psoriatic arthritis (PsA). METHODS: INVIGORATE-2 (NCT04209205) was a randomized, placebo-controlled, phase 3 trial. Patients with active PsA were randomized 1:1 to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks [q4w]) or placebo. At week 16, patients randomized to placebo were switched to IV secukinumab (3 mg/kg q4w), and patients who received IV secukinumab continued treatment through week 52. The primary efficacy endpoint was achievement of 50% improvement in American College of Rheumatology response criteria (ACR50) at week 16. Efficacy and safety were evaluated through weeks 52 and 60, respectively. RESULTS: Among 191 patients randomized to IV secukinumab and 190 to placebo/IV secukinumab, 177 (92.7%) and 170 (89.5%) completed the entire study period, respectively. A significantly higher proportion of patients who received IV secukinumab versus placebo achieved ACR50 at week 16 (31.4% vs 6.3%; adjusted P < 0.0001). All secondary efficacy endpoints were met at week 16 (all adjusted P < 0.05 using the predefined hypothesis-testing hierarchy). Patients who switched from placebo to secukinumab at week 16 showed rapid improvements in ACR50 rates; by week 52, both treatment arms experienced similar improvements in efficacy outcomes. No new or unexpected safety signals were observed with receiving IV secukinumab. One death was reported in the placebo group before week 16. CONCLUSION: IV secukinumab led to rapid and sustained improvements in clinical measures of PsA, and the safety profile was consistent with that of secukinumab administered subcutaneously.
- MeSH
- Antirheumatic Agents therapeutic use administration & dosage MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Antibodies, Monoclonal, Humanized * administration & dosage therapeutic use MeSH
- Administration, Intravenous MeSH
- Middle Aged MeSH
- Humans MeSH
- Arthritis, Psoriatic * drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
OBJECTIVE: The study objectives were (i) to explore the agreement between the Outcome Measures in Rheumatology (OMERACT) ultrasound lesions of enthesitis and physical examination in assessing enthesitis in patients with spondyloarthritis (SpA) and (ii) to investigate the prevalence and clinical relevance of subclinical enthesitis in this population. METHODS: Twenty rheumatology centers participated in this cross-sectional study. Patients with SpA, including axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA), underwent both ultrasound scan and physical examination of large lower limb entheses. The OMERACT ultrasound lesions of enthesitis were considered, along with a recently proposed definition for "active enthesitis" by our group. Subclinical enthesitis was defined as the presence of "active enthesitis" in ≥1 enthesis in patients with SpA without clinical enthesitis (ie, number of positive entheses on physical examination and Leeds Enthesitis Index score = 0). RESULTS: A total of 4,130 entheses in 413 patients with SpA (224 with axSpA and 189 with PsA) were evaluated through ultrasound and physical examination. Agreement between ultrasound and physical examination ranged from moderate (ie, enthesophytes) to almost perfect (ie, power Doppler and "active enthesitis"). Patellar tendon entheses demonstrated the highest agreement, whereas Achilles tendon insertion showed the lowest. Among 158 (38.3%) of 413 patients with SpA with clinical enthesitis, 108 (68.4%) exhibited no "active enthesitis" on ultrasound. Conversely, of those 255 without clinical enthesitis, 39 (15.3%) showed subclinical enthesitis. Subclinical enthesitis was strongly associated with local structural damage. However, no differences were observed regarding the demographic and clinical profiles of patients with SpA with and without subclinical enthesitis. CONCLUSION: Our study underscores the need for a comprehensive tool integrating ultrasound and physical examination for assessing enthesitis in patients with SpA.
- MeSH
- Achilles Tendon diagnostic imaging MeSH
- Axial Spondyloarthritis diagnostic imaging MeSH
- Adult MeSH
- Enthesopathy * diagnostic imaging MeSH
- Physical Examination * MeSH
- Middle Aged MeSH
- Humans MeSH
- Cross-Sectional Studies MeSH
- Arthritis, Psoriatic diagnostic imaging complications MeSH
- Spondylarthritis * diagnostic imaging complications MeSH
- Ultrasonography * MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
OBJECTIVES: To compare the drug survival of etanercept to monoclonal tumour necrosis factor-α inhibitors in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. METHODS: Patients initiating first line biological therapy with tumour necrosis factor-α were propensity score matched and compared for drug survival with a Kaplan-Meier analysis. RESULTS: We matched 657 to 657 patients in rheumatoid arthritis, the median survival time on etanercept was 44.6 months vs. 36.8 months on monoclonal antibody tumour necrosis factor-α inhibitors, with a hazard ratio of 0.94, p = 0.416 We matched 187 to 356 patients in ankylosing spondylitis, the median survival time on etanercept was 75.1 compared to 68.0 months, hazard ratio of 0.78, p = 0.087 We matched 81 to 160 psoriatic arthritis patients, the median survival time on etanercept was 35.8. compared to 65.7 months, hazard ratio 1.61, p = 0.011. Patients treated with etanercept had significantly worse psoriasis scoring during follow up. CONCLUSIONS: We found comparable survival in rheumatoid arthritis and ankylosing spondylitis. In psoriatic arthritis, we found significantly shorter survival on etanercept, possibly due to worse response of skin and nail manifestations.
- MeSH
- Adalimumab therapeutic use MeSH
- Spondylitis, Ankylosing * drug therapy mortality MeSH
- Antirheumatic Agents * therapeutic use MeSH
- Adult MeSH
- Etanercept * therapeutic use MeSH
- Infliximab therapeutic use MeSH
- Kaplan-Meier Estimate MeSH
- Middle Aged MeSH
- Humans MeSH
- Antibodies, Monoclonal therapeutic use MeSH
- Arthritis, Psoriatic * drug therapy mortality MeSH
- Registries * MeSH
- Arthritis, Rheumatoid * drug therapy mortality MeSH
- Aged MeSH
- Propensity Score * MeSH
- Tumor Necrosis Factor-alpha * antagonists & inhibitors MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Comparative Study MeSH
- Geographicals
- Czech Republic MeSH
OBJECTIVE: In patients with axial spondyloarthritis (axSpA) initiating secukinumab (SEC), we aimed to identify baseline (treatment start) predictors of achieving low disease activity (LDA) after 6 months, as measured by the Axial Spondyloarthritis Disease Activity Score using C-reactive protein (ASDAS-CRP) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), as well as treatment continuation after 12 months. METHODS: From 11 European registries, patients with axSpA who initiated SEC treatment in routine care, with available data on 6-month ASDAS-CRP and BASDAI assessments were included. Logistic regression analyses on multiply imputed baseline data were performed; potential baseline predictors included demographic, diagnosis, lifestyle, clinical, and patient-reported variables. RESULTS: In a pooled cohort of 1174 patients with axSpA, 5 of 19 potential assessed variables were mutually predictive for achieving LDA by ASDAS-CRP and BASDAI: higher physician global assessment score, noncurrent smoking, lack of prior exposure to biologic/targeted synthetic disease-modifying antirheumatic drugs, and lower Health Assessment Questionnaire scores and BASDAI scores. Moreover, radiographic axSpA and CRP ≤ 10 mg/L were associated with achieving ASDAS-CRP LDA, and HLA-B27 positivity and history of psoriasis with achieving BASDAI LDA, whereas earlier time of secukinumab initiation (2015-2017) was associated with treatment continuation. CONCLUSION: In this European real-world study of patients with axSpA initiating SEC, predictors of achieving LDA by ASDAS-CRP and BASDAI at 6 months and remaining on treatment at 12 months included both clinical, patient-reported, and lifestyle factors, underscoring the complex mechanisms of real-world drug effectiveness.
- MeSH
- Antirheumatic Agents * therapeutic use MeSH
- Axial Spondyloarthritis * drug therapy MeSH
- C-Reactive Protein metabolism MeSH
- Adult MeSH
- Antibodies, Monoclonal, Humanized * therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Registries MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Europe MeSH
Bimekizumab je humanizovaná monoklonální protilátka (imunoglobulin typu G1, IgG1), která selektivně a silně inhibuje interleukin (IL) 17A i 17F a je účinnější při potlačování prozánětlivých cytokinů in vitro ve srovnání s inhibicí samotných IL-17A nebo IL-17F. Podle výsledků z klinických studií fáze III BE OPTIMAL a BE COMPLETE duální inhibice IL-17A a IL-17F bimekizumabem vede k většímu zlepšení kloubních a kožních výsledků ve srovnání s placebem u pacientů s aktivní psoriatickou artritidou naivních vůči biologickým chorobu modifikujícím lékům (biologic disease-modifying antirheumatic drugs, bDMARD) nebo s předchozí nedostatečnou odpovědí nebo na inhibici tumor nekrotizujícího faktoru (TNF) nebo s intolerancí inhibice TNF. Po 16 týdnech dosáhlo 50% zlepšení podle klasifikačních kritérií American College of Rheumatology (ACR50) více pacientů v léčebných skupinách než ve skupinách s placebem (44 % oproti 10 % ve studii BE OPTIMAL; 43 % oproti 7 % ve studii BE COMPLETE). Bezpečnostní profil bimekizumabu byl konzistentní s předchozími zprávami.
Bimekizumab is a humanized monoclonal IgG1 antibody that selectively and potently inhibits both interleukin (IL) 17A and 17F and is more effective at suppressing proinflammatory cytokines in vitro compared with inhibition of IL-17A or IL-17F alone. Dual inhibition of IL-17A and IL-17F with bimekizumab leads to superior improvements in joint and skin outcomes compared with placebo in patients with active psoriatic arthritis who are either naive to biologic disease-modifying antirheumatic drugs (bDMARD) or who have had a previous inadequate response or intolerance to TNF inhibition, according to results from the BE OPTIMAL and BE COMPLETE phase III clinical trials. At 16 weeks, more patients reached 50% improvement according to the American College of Rheumatology classification criteria (ACR50) response in the treatment groups than in the placebo groups (44 % versus 10 % for the BE OPTIMAL trial; 43 % versus 7 % for the BE COMPLETE trial). The safety profile of bimekizumab was consistent with previous reports.
- Keywords
- studie BE OPTIMAL, bimekizumab, studie BE COMPLETE,
- MeSH
- Antibodies, Monoclonal, Humanized pharmacology therapeutic use MeSH
- Tumor Necrosis Factor Inhibitors pharmacology therapeutic use MeSH
- Interleukin-17 * antagonists & inhibitors pharmacology MeSH
- Clinical Studies as Topic MeSH
- Humans MeSH
- Arthritis, Psoriatic * diagnosis drug therapy immunology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Review MeSH
BACKGROUND: Studies on national policies for biologics are warranted. OBJECTIVES: To map and compare national healthcare set-ups for prescription, start, switch, tapering, and discontinuation of biologic/targeted synthetic disease-modifying antirheumatic drugs (DMARDs) in patients with psoriatic arthritis and axial spondyloarthritis across Europe, and assess the healthcare set-ups in relation to countries' socio-economic status. METHODS: An electronic survey was developed to collect and compare information on national healthcare systems. The relationship between the cumulative score of biologic/targeted synthetic DMARD regulations, socioeconomic indices, and biologic originator costs were assessed by linear regression. RESULTS: National healthcare set-ups differed considerably across the 15 countries, with significantly fewer regulations with increasing socioeconomic status measured by GDP/current health expenditure/human development index, and with increasing biologic originator costs. In most countries, the biologic/targeted synthetic DMARD prescribing doctor was required to adhere to country and/or hospital recommendations, and about a third of countries had a national/regional tender process. Prescription regulations for biologic/targeted synthetic DMARDs, including pre-treatment and disease activity requirements, varied substantially. Approximately a third of countries had criteria for discontinuation and tapering, whereas only few had for switching. Notably, two countries disallowed biologic/targeted synthetic DMARD retrials, and one imposed limit on the maximum number of biologic/targeted synthetic DMARDs permitted. CONCLUSION: The findings highlight substantial variability in healthcare set-ups for biologic/targeted synthetic DMARD use in psoriatic arthritis and axial spondyloarthritis across Europe and their association with socioeconomic status and drug costs. These insights provide a basis for rheumatology societies, policymakers, and stakeholders to evaluate and potentially optimize healthcare policies.
- MeSH
- Antirheumatic Agents * therapeutic use economics MeSH
- Axial Spondyloarthritis * drug therapy MeSH
- Biological Products therapeutic use economics MeSH
- Healthcare Disparities * statistics & numerical data MeSH
- Humans MeSH
- Delivery of Health Care * organization & administration MeSH
- Surveys and Questionnaires MeSH
- Arthritis, Psoriatic * drug therapy MeSH
- Spondylarthritis * drug therapy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Geographicals
- Europe MeSH