Background: In the post-hoc analysis of PLANETRA, a Phase III randomized controlled trial (RCT), no significant association was found between body mass index (BMI) and clinical responses in rheumatoid arthritis (RA) patients using weight-based intravenous (IV) infliximab (3 mg/kg every 8 weeks) 1,2 . Since the subcutaneous (SC) formulation of CT-P13 which was approved from EMA after demonstrating non-inferiority compared to CT-P13 IV is a fixed-dose of 120 mg biweekly, it is meaningful to evaluate the impact of BMI on clinical response of CT-P13 SC 3,4 . Objectives: This report is to investigate post-hoc impact of BMI on clinical responses of CT-P13 SC 120 mg in Part 2 of a Phase I/III RCT in active RA patients throughout the 1-year treatment period. Methods: A total of 165 patients who received at least one full dose of CT-P13 SC (after IV induction at Weeks 0 and 2) in the initial treatment stage before Week 30 and who had at least one efficacy evaluation result after Week 6 or thereafter were included in this analysis. Patients were categorized into 3 groups; under/normal weight (<25kg/m 2 ), overweight (≥25kg/m 2 , <30kg/m 2 ), and obesity (≥30kg/m 2 ) based on the WHO BMI classification. Baseline characteristics, mean change from baseline in disease activity by DAS28 (CRP), remission (DAS28 [CRP]≤2.6) and low disease activity (LDA; 2.6<DAS28 [CRP]≤3.2), duration (week) of LDA, EULAR response, and ACR response were evaluated among the 3 BMI groups. Results: In the under/normal weight (n=63), overweight (n=61), and obesity (n=41) groups, the mean±SD of age (years) (48.7±14.00, 51.5±10.93, 53.8±10.62) and the mean±SD of RA duration (years) (6.4±6.00, 8.2±9.27, 5.4±4.72) were comparable. At baseline, the rates of high disease activity (90.5%, 90.2%, 87.8%; DAS28 [CRP]>5.1) were similar among the groups. All other baseline and disease characteristics including gender, race, and other disease activity parameters were also comparable among the groups. The rate of remission or LDA (Figure 1), the mean change from baseline of DAS28 (CRP) (-3.3, -3.1, -3.3 at Week 54), duration of LDA up to Week 54 (26.2, 29.2, 27.9 weeks), and the good or moderate EULAR responder rates (84.1%, 80.3%, 90.2% at Week 54) were all comparable among the groups and there were no statistically significant differences (p-value>0.05). The ACR responder rates were also comparable among the groups except for the ACR70 at Weeks 2 and 6 which were obtained following 2 IV infusions in the IV dose loading phase. Absolute value of Pearson correlation coefficient was below 0.06 between BMI at screening and mean change from baseline in DAS28 (CRP) during CT-P13 SC treatment from Weeks 14 to 54, indicating that correlation between two measurements was weak and was not statistically significant (p-value>0.05) (Figure 2). Figure 1. Remission or LDA Based on DAS28 (CRP) Figure 2. DAS28 (CRP) improvement Conclusion: These post-hoc results showed that there was no impact of BMI on the clinical responses of CT-P13 SC 120 mg biweekly in RA patients. Therefore, CT-P13 SC 120 mg could be a reasonable therapeutic option regardless of BMI. References: [1]Yoo D.H., et al. Ann Rheum Dis, 2013;72:1613-20. [2]Yoo D.H., et al. Ann Rheum Dis, 2016;75:1005. [3]Westhovens R., et al. Ann Rheum Dis, 2019;78:A1158 [4]Westhovens R., et al. Arthritis Rheumatol. 2019;71 (suppl 10). Disclosure of Interests: DaeHyun Yoo Grant/research support from: Celltrion, Inc, Consultant of: Celltrion, Inc, Speakers bureau: Celltrion Healthcare, Inc, Rene Westhovens Grant/research support from: Celltrion Inc, Galapagos, Gilead, Consultant of: Celltrion Inc, Galapagos, Gilead, Speakers bureau: Celltrion Inc, Galapagos, Gilead, Piotr Wiland Grant/research support from: Celltrion, Inc, Speakers bureau: Novartis, Pfizer, Abbvie, Gedeon-Richter, Lilly, Roche, Sandoz, Marek Zawadzki Grant/research support from: Celltrion, Inc, Delina Ivanova Grant/research support from: Celltrion, Inc, Alfredo Berrocal Grant/research support from: Celltrion, Inc, Speakers bureau: Pfizer, Elias Chalouhi Grant/research support from: Celltrion, Inc, Éva Balázs Grant/research support from: Celltrion, Inc, Consultant of: Amgen, Sergii Shevchuk Grant/research support from: Celltrion, Inc, Sang Joon Lee Shareholder of: Celltrion, Inc, Employee of: Celltrion, Inc, Sung Hyun Kim Shareholder of: Celltrion, Inc, Employee of: Celltrion, Inc, NooRi Han Employee of: Celltrion, Inc., YooBin Jung Employee of: Celltrion, Inc
Jednym z ważniejszych problemów wynikających ze specyfiki choroby przewlekłej, jej leczenia i związanych z nią działań niepożądanych jest trwała lub ograniczona zdolność do inicjowania i realizowania potrzeb właściwych dla danej fazy rozwojowej osoby chorej. Dla kobiet w wieku rozrodczym jest to m.in. planowanie rodziny i posiadanie dzieci. Problem ciąży u kobiet z rozpoznaniem choroby reumatycznej jest związany nie tylko z uwarunkowaniami natury fizycznej, lecz także psychologicznej. Duża część kobiet cierpiących na choroby reumatyczne nie podejmuje prób zajścia w ciążę. Powodem jest m.in. brak wiedzy na temat możliwości realizacji planów związanych z macierzyństwem oraz wpływ społecznych stereotypów dotyczących ograniczeń wynikających z niepełnosprawności. Dlatego ważnym elementem oddziaływania na postawę pacjentek jest rzetelna edukacja, która dostarcza wsparcia informacyjnego i instrumentalnego polegającego na praktycznym instruktażu dotyczącym konkretnych sposobów postępowania w danej sytuacji.
Objectives Biologics are medications widely applied in the management of inflammatory rheumatic diseases. The drugs were found to be effective but their application is associated with some disadvantages. Medication with biologics is relatively expensive, and in Poland, it is carried out in specialized centers. The study was designed to evaluate various aspects of satisfaction and dissatisfaction of Polish patients treated with biologics. Material and methods An anonymous questionnaire was distributed in 23 Polish rheumatological centers involved in the treatment; 1212 returned questionnaires were used for analysis. Responses were received from 606 patients with rheumatoid arthritis, 427 with ankylosing spondylitis, 117 psoriatic arthritis, and 62 adult patients with juvenile idiopathic arthritis (in whom administration of the drugs had been introduced before they were 18 years old). The investigated group constituted about one-fifth of all rheumatic patients on biologics in Poland. Results A beneficial or very beneficial influence of the medication on the state of physical health was found mostly in patients with rheumatoid arthritis (51.3 and 30.5%) and ankylosing spondylitis (51.0 and 36.8%). Family life was improved by the treatment especially in patients with ankylosing spondylitis (40.7 and 35.6% beneficial and very beneficial, respectively), sleep quality and sexual life mostly in those with ankylosing spondylitis (beneficial/very beneficial influence 41.5/38.4, and 38.7/23.9, respectively). There was a rather small influence of biological treatment on the financial situation of the patients. In general, satisfaction with the treatment was evaluated as positive or very positive in 88% of all investigated patients. In a significant part of the patients, transportation to the medical center was considered as a disadvantage of the treatment. About one-third of the patients considered laboratory and imaging tests to be done before initiation of the medication as a difficulty, and for about 40% waiting time for qualification for the medication was a significant disadvantage. The route of drug administration was without importance for 4/5 of the patients. Conclusions Summing up, the results were similar in the patients suffering from various diseases although those with psoriatic arthritis felt the highest satisfaction (possibly due to the positive aesthetic effect), and those with ankylosing spondylitis had significant improvement in sexual life (probably due to younger age). Relatively low satisfaction was found in patients with juvenile idiopathic arthritis. There was a small influence of medication on financial status of the patients. Application of biologics has few disadvantages and most of them are associated with the organization of health services (waiting time for the tests, transportation to the medical centers).
Vitamin D, because of its pleiotropic effect, is involved in many aspects of pathophysiology including calcium-phosphorus metabolism, cellular growth and differentiation and immune functions. Epidemiological studies suggest that deficiency of vitamin D may be a risk factor of many conditions including autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus [1,2]. There are reports showing an inverse relationship between vitamin D concentrations and measures of disease activity in early inflammatory arthritis [3]. But some other data are conflicting [4].
Objectives
To estimate the vitamin D status in patients with early arthritis and to find relationship with some relevant features of disease activity. To examine associations between 25(OH)D level and current treatment.
Methods
The study participants were patients with the diagnosis of early arthritis (lasting <2years) hospitalized in the Dept. of Rheumatology University Hospital, Wroclaw, Poland. 25(OH)D was measured in serum samples using commercial ELISA kit, all the necessary data concerning disease activity were also collected. Functional status was derived from HAQ questionnaire. Patients were diagnosed as having vitamin D deficiency when serum level of 25(OH)D were under 30 ng/ml.
Results
A total of 39 patients (31 women, 8 men,), mean age 45.2±16.8 years were included in the study. In analyzed group mean disease duration was 6.3±7.3 months. Estimated disease activity according to DAS28 had a mean value 4.8±1.4. Mean serum level of 25(OH)D was 18.1±9.4 ng/ml. Only 2 out of 39 patients had 25(OH)D level over 30 ng/ml, the rest had under 12 ng/ml (severe deficiency). There was no correlation between vitamin D level and parameters of disease activity (ESR, C reactive protein, DAS28, morphologic parameters of the peripheral blood) or functional status. There was also no differences in 25(OH)D serum concentrations among women and men. Analyzing the influence of the treatment on 25(OH)D levels, the levels was significantly higher in patients treated with sulphasalazin, compared to those not treated with any of the disease modifying antirheumatic drugs. The use of corticosteroids (mean dose of prednisone in the study group was 10.4±8.6 mg per 24h) did not influence the 25(OH)D serum level significantly.
Conclusions
The prevalence of vitamin D deficiency among patients with early arthritis is very high. The appropriate treatment regiments seem to influence the serum 25(OH)D levels. In contrast to earlier reports with recent-onset inflammatory arthritis, in our study, there were no associations between 25(OH)D levels and disease activity.
References
Fletcher JM, Basdeo SAet al. Therapeutic use of vitamin d and its analogues in autoimmunity.Recent Pat Inflamm Allergy Drug Discov.2012 Jan 1;6(1):22-34. Cutolo M, Pizzorni C, Sulli A. Vitamin D endocrine system involvement in autoimmune rheumatic diseases.Autoimmun Rev.2011 Dec;11(2):84-7. Patel S, et al. Association between serum vitamin D metabolite levels and disease activity in patients with early inflammatory polyarthritis. Arthritis Rheum. 2007; 56(7):2143–9. Craig SM, Yu F, Curtis JR, Alarcόn GS et al. Vitamin D status and its associations with disease activity and severity in African Americans with recent-onset rheumatoid arthritis.J Rheumatol.2010 Feb;37(2):275-81.
Abstract Objectives Primary Sjögren’s syndrome (pSS) is an autoimmune, multisystem exocrinopathy characterized by dysfunction of the exocrine glands. Central nervous system (CNS) involvement is estimated to be present in 10–60% patients with pSS. The present study aimed to evaluate brainstem auditory evoked potentials (BAEP) in pSS patients without central nervous system involvement, and without otolaryngological abnormalities. Method Thirty-six pSS patients (35 women, 1 man, mean age 48 years old) and 40 healthy volunteers were investigated. BAEP, brain imaging, laboratory parameters, and clinical neurological and otolaryngological examinations were performed. Results Abnormal BAEP were recorded in 16.7% patients. The mean wave BAEP I and V latency and mean wave III-V and I-V interpeak latencies were significantly longer in pSS patients than the controls. There were no statistically significant correlations between BAEP parameters and laboratory tests. None of the patients was found having the abnormalities on brain imaging. Conclusions This study confirms that in pSS patients without clinical central nervous system impairment, auditory pathway disturbances could be found. Disorders of brain bioelectrical activity may be a consequence of ongoing autoimmune process. Key Points • BAEP abnormalities confirmed the clinically observed involvement of the central nervous system in patients with pSS. • Brain bioelectrical activity dysfunctions in pSS patients may be a consequence of ongoing inflammatory and/or immunological processes.
Involvement of the non-classical human leucocyte antigen-E (HLA-E) in both innate and acquired immune response suggests its possible role in development of autoimmune pathologies. This study was undertaken to investigate relationships between the HLA-E gene single nucleotide polymorphisms (SNPs) and a risk of rheumatoid arthritis (RA), as well as to evaluate a potential of these polymorphisms to modulate clinical outcome of anti-tumour necrosis factor (TNF) treatment in female patients. A total of 223 female patients with RA receiving anti-TNF biological therapy and 134 female healthy subjects were enrolled into the study. Genotypings for two SNPs within the HLA-E gene (rs1264457 HLA-E*01:01/01:03; rs1059510 HLA-E*01:03:01/01:03:02) were performed using a polymerase chain reaction (PCR) amplification employing LightSNiP assays. Clinical response was evaluated according to the European League Against Rheumatism (EULAR) criteria at 12 and 24 weeks after initiation of the therapy. The frequency of the HLA-E*01:01/01:01 genotype was decreased significantly in RA patients in comparison to controls (P = 0.031). The presence of the HLA-E*01:01/01:01 genotype in patients correlated with better EULAR response after 12 weeks of anti-TNF treatment, while 01:03 allele carriers were generally unresponsive to the treatment (P = 0.014). The HLA-E*01:03/01:03 genotype was also over-represented among non-responding patients in comparison to HLA-E*01:01/01:01 homozygotes (P = 0.021). With respect to the HLA-E rs1059510 variation, a better response after 12 weeks was observed more frequently in patients carrying the HLA-E*01:03:01/01:03:01 genotype than other genotypes (P = 0.009). The results derived from this study imply that HLA-E polymorphisms may influence RA susceptibility and affect clinical outcome of anti-TNF therapy in female RA patients.
Abstract Objective To characterize the systemic phenotype of primary Sjögren’s syndrome at diagnosis by analysing the EULAR-SS disease activity index (ESSDAI) scores. Methods The Sjögren Big Data Consortium is an international, multicentre registry based on worldwide data-sharing cooperative merging of pre-existing databases from leading centres in clinical research in Sjögren’s syndrome from the five continents. Results The cohort included 10 007 patients (9352 female, mean 53 years) with recorded ESSDAI scores available. At diagnosis, the mean total ESSDAI score was 6.1; 81.8% of patients had systemic activity (ESSDAI score ≥1). Males had a higher mean ESSDAI (8.1 vs 6.0, P < 0.001) compared with females, as did patients diagnosed at <35 years (6.7 vs 5.6 in patients diagnosed at >65 years, P < 0.001). The highest global ESSDAI score was reported in Black/African Americans, followed by White, Asian and Hispanic patients (6.7, 6.5, 5.4 and 4.8, respectively; P < 0.001). The frequency of involvement of each systemic organ also differed between ethnic groups, with Black/African American patients showing the highest frequencies in the lymphadenopathy, articular, peripheral nervous system, CNS and biological domains, White patients in the glandular, cutaneous and muscular domains, Asian patients in the pulmonary, renal and haematological domains and Hispanic patients in the constitutional domain. Systemic activity measured by the ESSDAI, clinical ESSDAI (clinESSDAI) and disease activity states was higher in patients from southern countries (P < 0.001). Conclusion The systemic phenotype of primary Sjögren’s syndrome is strongly influenced by personal determinants such as age, gender, ethnicity and place of residence, which are key geoepidemiological players in driving the expression of systemic disease at diagnosis.
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