Demographic and clinical characteristics of patients with sustained and switching treatments using biological and targeted synthetic disease-modifying antirheumatic drugs: A multicenter, observational cross-sectional study for rheumatoid arthritis

Introduction Rheumatoid arthritis is a chronic inflammatory disease with different disease activity grades. Several registries have been designed to determine the appropriate regimens of disease-modifying antirheumatic drugs to obtain sustained clinical remission. We examined epidemiological and clinical characteristics of rheumatoid arthritis patients using a clinical registry database (BioSTaR) and analyzed the differences in patients with sustained and switched therapies. Methods A multicenter, observational cross-sectional study for rheumatoid arthritis was performed between February 2019 and September 2020 using the BioStaR-RA registry. Demographic and clinical characteristics were prospectively recorded into a specifically designed electronic database. The patients were divided into three groups due to the heterogeneity of the study cohort. Patients were grouped as Group I (Initial; within the first 6 months of treatment with biological/targeted synthetic drugs), Group ST (Sustained Treatment; any first drug lasting for at least 6 months without any change), and Group S (Switch; any switching to another drug). Comparative analysis was performed between sustained treatment (Group ST) and drug switching (Group S) groups. Results The study included a total of 565 patients. The mean age was 53.7 +/- 12.8 years, and the majority were female (80.4%). There were 104, 267, and 194 patients in Groups I, ST, and S, respectively. Erosive arthritis and hematological extra-articular involvement were more frequently detected in Group S than Group ST (p = 0.009 and p = 0.001). The patients in Group S had significantly higher disease activity scores (DAS28-CRP, CDAI, and SDAI) (p = 0.025, p = 0.010, and p = 0.003). There were significantly more patients with moderate disease activity in Group S (p < 0.05). Conclusions The groups with sustained treatment and switching included patients with different disease activity status, although higher disease activity was determined in switchers. Overall, moderate disease activity and remission were the most common disease activity levels. Lower disease activity scores, lower hematologic manifestations, better functional status, and lesser radiographic damage are associated with sustained treatment.Turkish Medicine and Medical Devices Agency ; Ankara Numune Egitim ve Arastirma Hastanes

Can the Second to Fourth Digit Ratio (2D : 4D) Be a Marker to Determine Ankylosing Spondylitis Disease Activity?

Objective. The length ratio of the index finger (2D) to the ring finger (4D) (2D : 4D ratio) is considered a biomarker of prenatal sex hormone exposure. The 2D : 4D ratio is influenced by prenatal androgen and estrogen levels. Because ankylosing spondylitis (AS) influences men more frequently and severely than women, androgens are proposed to be related to AS pathogenesis. Estrogens have immune-modulating effects and reduce AS disease activity. The aim of this study was to assess the relationship between 2D : 4D ratio and AS disease activity. Material and Methods. In this study, 167 (43 female) patients diagnosed with AS were studied. The lengths of the second and fourth fingers were measured using a digital caliper. The 2D : 4D ratio was found by dividing the length of the second finger by the length of the fourth finger. AS disease activity was assessed with the Turkish version of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). AS functional status was assessed with Bath Ankylosing Spondylitis Functional Index (BASFI). L-Schober, tragus to wall distance, finger to floor distance, and chest expansion were used to evaluate mobility. Results. In female patients, the right hand 2D : 4D ratios were higher than those in male patients. Biologic drug use was more frequent in males. The BASDAI scores were higher in female patients than in male patients. There were significant negative correlations between right and left hand 2D : 4D ratio and BASFI and BASDAI in female patients. There was no significant correlation between the 2D : 4D ratio and BASFI or BASDAI in male patients. We found a positive correlation between L-Schober and right hand 2D : 4D and a negative correlation between the left hand 2D : 4D ratio and finger to floor distance in female patients with AS. Conclusion. The 2D : 4D ratio of the right and left hand was low in female patients with high BASFI and BASDAI and low spinal mobility (L-Schober) was also linked to low female 2D : 4D. The lack of strong associations between 2D : 4D and AS in male patients may have resulted from their higher use of biologics

Is there any prognostic significance in pleural involvement and/or effusion (Ple-I/E) in patients with ALK-positive NSCLC?

Conference Conference: 44th Congress of the European-Society-for-Medical-Oncology (ESMO) Location: Barcelona, SPAIN Date: SEP 27-OCT 01, 2019 Sponsor(s):European Soc Med Oncol; Japanese Soc Med OncolBackground: ALK mutation occurs in approximately 3-5% of patients with NSCLC. At the baseline, Ple-I/E are more frequent in ALKþ patients with NSCLC. In the study, we aimed to evaluate characteristics of ALKþpatients who have Ple-I/E. Methods: In this multicenter study, patients with ALKþ NSCLC who have Ple-I/E were retrospectively analyzed. Clinical and demographic characteristics of the disease, response rates, median PFS and OS were evaluated in 362 ALKþpatients with NSCLC. Results: Of the patients, 198 (54.7%) were male. The median age at the time of diagnosis was 54 (21-85) years. The median age was higher in male (57 vs 52 years; p¼0.011). The most common histology was adenocarcinoma (100%). At the baseline, 57 (15.7%) patients had Ple-I/E. The median age of patients with Ple-I/E was similar to patients without Ple-I/E (53 vs 55 years; p¼0.541). The rate of smokers was 43.4% (n¼157) in the patients. There was no association between Ple-I/E and gender, lung metastasis and distant LAP metastasis. Pleural involvement was higher in non-smokers than smokers (19.4% vs 13.4%; p¼0.077), but not statistically significant. The frequencies of liver, brain and bone metastasis were a significant higher in ALKþpatients with Ple-I/E compared to those with non-metastatasis (respectively 18.2% vs 4.8%, p¼0.008; 19.1% vs 4.8%, p¼0.002; 20.6% vs 8.9%, p¼0.003). The median PFS was longer in ALKþ patients who have Ple-I/E 18.7 vs 10.6 months, p¼0.017). The 1-, 2- and 3-year PFS were 59%, 36%, and 24% in patients with Ple-I/E and 47%, 24%, and 8% in patients with non-involvement. Similarly, the median OS was longer in ALKþpatients who have pleural involvement/infusion 44.6 vs 22.6 months, p¼0.051). The 1-, 2- and 3- year OS were 78%, 67%, and 57% in patients with Ple-I/E and 66%, 48%, and 34% in patients with non-involvement. Conclusions: Brain, liver and bone metastases are lower in ALKþpatients with Ple-I/E. Presentation with Ple-I/E in patients with ALKþ NSCLC is associated with longer overall and progression-free survival. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.European Society for Medical OncologyJapanese Society of Medical Oncolog

Clinical performance of ASAS health index in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: Real-world evidence from Multicenter Nationwide Registry

The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is used as a new instrument in measuring the function, disability and health of patients with spondyloarthritis (SpA). However, the real-world evidence of ASAS HI is very limited. In the present study, our objective is to evaluate the psychometric properties and performance of ASAS HI in the real-world setting as well as comparing ASAS HI with the current instruments to assess the construct validity and determine the cut-off points in patients with both ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). A total of 991 patients with axSpA who fulfilled either the ASAS classification criteria for axial SpA (axSpA) or the Modified New York Criteria (mNY) for AS were recruited from the Biologic and targeted Synthetic antirheumatic drugs Registry (BioStaR) SpA. The construct validity of ASAS HI against the Bath Ankylosing Spondylitis Disease Activities Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein (ASDAS-CRP) the Bath Ankylosing Spondylitis Functional index (BASFI) was performed. Using the receiver operating characteristic (ROC) curves analysis, the cut-off points were calculated. Of all the recruited patients, 851 (85.9%) were AS and 140 (14.1%) were nr-axSpA. The difference in the mean ASAS HI scores of the patients with AS and the ones with nr-axSpA were not statistically significant (6.12 +/- 4.29 and 6.42 +/- 4.86, respectively). The mean ASAS HI score was significantly higher in females and small city residents. The ASAS HI had a strong construct validity against ASDAS-CRP, BASDAI and BASFI. A cut-off point of = 12 to discriminate moderate and poor health status. In conclusion, ASAS HI is a reliable instrument to evaluate health and functioning for both patients with AS and nr-axSpA in clinical practice.Turkish League Against Rheumatism (TLAR

Clinical performance of rheumatoid arthritis impact of disease score: A real-life evidence from the multicenter nationwide registry BioStaR

The rheumatoid arthritis impact of disease (RAID) score was developed as a patient-derived composite response index for the evaluation of the disease impact on cases with rheumatoid arthritis (RA). The aim of this study was to evaluate the psychometric properties and performance of RAID score in the real-life settings. Cases with RA from our multi-center, nationwide registry called Biologic and targeted Synthetic antirheumatic drugs Registry RA (BioStaR RA) were included in this cross-sectional observational study. Demographic data, disease duration, pain, patient's global assessment (PGA) and physician's global assessment (PhyGA) were recorded. DAS28-ESR, DAS28-CRP, the simplified disease activity index (SDAI) and the clinical disease activity index (CDAI) were assessed as disease activity evaluations. The health assessment questionnaire-disability index (HAQ-DI) and RAID were completed by all the participants. The construct validity was tested by the analysis of correlations between RAID score and scores of PGA, disease activity indexes and HAQ-DI. We also evaluated the discriminatory ability of RAID to distinguish patients with different levels of disease activity and disability and the cut-off values were calculated by ROC analysis. 585 cases with RA were included in this investigation. The RAID score was significantly positively correlated with PGA, all disease activity indexes and HAQ-DI (p < 0.001). The discriminatory ability of RAID score in different disease activity and disability groups was also demonstrated (p < 0.001). To estimate DAS28-ESR (remission/low + moderate + high), RAID score cut-off points were 2.88 (sensitivity 73%, specificity 62%), 3.23 (sensitivity 75%, specificity 60%) and 3.79 (sensitivity 74%, specificity 58%), respectively. Our study indicated that RAID was a reliable tool in daily clinical practice by presenting its correlations with disease activity and disability assessments and by showing its discriminatory ability in these parameters in the real-life experiences.Turkish League Against Rheumatism (TLAR

Where we are in treat to target era? Predictive factors for remission and drug switching in patients with axial spondyloarthritis: A real-life evidence from BioStaR nationwide registry

Objectives Factors associated with disease activity of axial spondyloarthritis (axSpA) and switching of biologic disease-modifying anti-rheumatic drugs have not been clearly defined. We aimed to evaluate clinical characteristics of patients with axSpA, factors related to remission in treat to target era and predictive factors for biologic disease-modifying anti-rheumatic drug switching. Method A multicenter, observational cross-sectional study was performed between February 2019 and August 2019. We included all consecutive patients >= 18 years with axSpA. Demographic and clinical variables were prospectively recorded. Clinical tools included Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Metrology Index (BASMI), and Maastricht Ankylosing Spondylitis Enthesitis Score (MASES). Results There were 969 patients with a mean age of 43.4 +/- 10.8 years. There were 143 patients (14.8%) with remission and 223 (23.1%) patients with low disease activity. Male sex (p = 0.021), positive family history (p = 0.036), and human leukocyte antigen-B27 (p = 0.011) were predictors of remission by ASDAS-CRP. There were 654 patients (67.5%) who did not switch to another drug. The highest BASMI and MASES scores were calculated in patients with very high disease activity (p < 0.05). In patients with drug switching, the disease duration was significantly higher (p < 0.001) and the age at diagnosis was significantly lower (p = 0.016). There were significantly more patients with uveitis and higher scores of MASES and BASMI in patients who switch to another biologic disease-modifying anti-rheumatic drugs (p = 0 .003, p = 0 .009, and p = 0.004, respectively). Conclusions In patients with axSpA, male sex, younger age, and HLA-B27 positivity are associated with remission, while longer disease duration and accompanied uveitis appear to be related with drug switching