ABSTRACT
OBJECTIVES: To assess, in spondyloarthritis (SpA), the discriminative value of the Outcome Measures in Rheumatology (OMERACT) ultrasound lesions of enthesitis and their associations with clinical features in this population. METHODS: In this multicentre study involving 20 rheumatology centres, clinical and ultrasound examinations of the lower limb large entheses were performed in 413 patients with SpA (axial SpA and psoriatic arthritis) and 282 disease controls (osteoarthritis and fibromyalgia). 'Active enthesitis' was defined as (1) power Doppler (PD) at the enthesis grade ≥1 plus entheseal thickening and/or hypoechoic areas, or (2) PD grade >1 (independent of the presence of entheseal thickening and/or hypoechoic areas). RESULTS: In the univariate analysis, all OMERACT lesions except enthesophytes/calcifications showed a significant association with SpA. PD (OR=8.77, 95% CI 4.40 to 19.20, p<0.001) and bone erosions (OR=4.75, 95% CI 2.43 to 10.10, p<0.001) retained this association in the multivariate analysis. Among the lower limb entheses, only the Achilles tendon was significantly associated with SpA (OR=1.93, 95% CI 1.30 to 2.88, p<0.001) in the multivariate analyses. Active enthesitis showed a significant association with SpA (OR=9.20, 95% CI 4.21 to 23.20, p<0.001), and unlike the individual OMERACT ultrasound lesions it was consistently associated with most clinical measures of SpA disease activity and severity in the regression analyses. CONCLUSIONS: This large multicentre study assessed the value of different ultrasound findings of enthesitis in SpA, identifying the most discriminative ultrasound lesions and entheseal sites for SpA. Ultrasound could differentiate between SpA-related enthesitis and other forms of entheseal pathology (ie, mechanical enthesitis), thus improving the assessment of entheseal involvement in SpA.
Subject(s)
Enthesopathy , Spondylarthritis , Ultrasonography, Doppler , Humans , Female , Male , Enthesopathy/diagnostic imaging , Adult , Middle Aged , Ultrasonography, Doppler/methods , Spondylarthritis/diagnostic imaging , Spondylarthritis/complications , Arthritis, Psoriatic/diagnostic imaging , Arthritis, Psoriatic/complications , Severity of Illness Index , Achilles Tendon/diagnostic imaging , Achilles Tendon/pathology , Case-Control StudiesABSTRACT
BACKGROUND: Approximately 80% of all proximal humeral fractures (PHFs) are non-displaced or minimally displaced fractures, which can be treated with conservative treatment. This study investigated the effect of interferential current (IFC) added to orthopedic rehabilitation on shoulder function, pain, and disability in patients with PHF. METHODS: This study was a prospective, double-blind, randomized, placebo-controlled conducted in physical medicine and rehabilitation outpatient clinic. Thirty-five patients were randomly separated into the IFC group (n = 18) and the sham group (n = 17). The orthopedic rehabilitation program was applied to all patients by the same physiotherapist three times a week for four weeks. Patients in the IFC group received the intervention for 20 minutes 3 times a week before the exercise. The same pads were performed for the sham group, but no electrical stimulation was applied. Constant-Murley score (CMS) for shoulder function, visual analog scale (VAS) activity pain, disabilities of the arm, shoulder, and hand (DASH) score, and paracetamol intake were recorded post-treatment, at 6 weeks and 18 weeks post-treatment. RESULTS: The demographic and fracture characteristics were not different between the groups. Significant differences were observed in the IFC and sham group in intragroup comparisons of total CMS, VAS activity pain, DASH score, and paracetamol intake over time (p < 0.001). Significant improvement over time was valid for all pairwise comparisons in both groups. However, no significant differences were detected between the IFC and sham group. CONCLUSION: IFC added to orthopedic rehabilitation could not appear to be an electrotherapy modality that could potentially benefit shoulder function and disability in patients with PHF.
Subject(s)
Acetaminophen , Shoulder Fractures , Humans , Prospective Studies , Treatment Outcome , Double-Blind Method , Shoulder Fractures/therapy , PainABSTRACT
OBJECTIVES: The objectives of this study were to assess the clinical characteristics, predictive factors, and practical algorithms of paradoxical reactions (PRs), specifically paradoxical psoriasis (PP). METHODS: The TReasure database is a web-based prospective observational cohort comprised of patients with RA and SpA from 17 centres around Turkey since 2017. A cohort study and a case-control study nestled within the cohort were identified. RESULTS: In total, 2867 RA and 5316 SpA patients were evaluated. The first biologic agent was found to have caused PRs in 60% of the 136 patients (1.66%) who developed the PRs. The median time interval between the PRs and biological onset was 12 months (range 1-132 months, mean 21 months). The most common types of PP, constituting 92.6% of PRs, were pustular (60.3%) and palmoplantar (30.9%). Adalimumab (30.9%), infliximab (19%) and etanercept (17.4%) were the most common agents causing the PP. In the treatment of most PP patients (73.2%), switching biologic agents was favoured, with TNF inhibitor (TNFi) chosen in 46.03% and non-TNFi in 26.9% of cases. The three most frequently selected drugs were etanercept (24.6%), secukinumab (9.5%) and adalimumab (8.7%). Only 5.17% of patients who switched to another TNFi showed progression. The odds ratios (s) for SSZ, HCQ, and LEF use were significantly higher in RA controls than in PP patients (P = 0.033, OR = 0.15; P = 0.012, OR = 0.15; and P = 0.015, OR = 0.13, respectively). In the PP group with SpA, the number of smokers was significantly higher (P = 0.003, OR: 2.0, 95% CI: 1.05, 3.81). CONCLUSION: Contrary to expectations based on earlier research suggesting that paradoxical reactions develop with the class effect of biological agents, the response of patients who were shifted to another TNFi was favourable.
Subject(s)
Antirheumatic Agents , Psoriasis , Humans , Adalimumab/adverse effects , Antirheumatic Agents/adverse effects , Biological Factors/adverse effects , Biological Therapy/adverse effects , Case-Control Studies , Cohort Studies , Etanercept/adverse effects , Follow-Up Studies , Infliximab/adverse effects , Psoriasis/drug therapy , Psoriasis/chemically induced , Tumor Necrosis Factor Inhibitors , Tumor Necrosis Factor-alphaABSTRACT
Background: Mepolizumab 300 mg is an approved treatment option for patients with eosinophilic granulomatosis with polyangiitis (EGPA), yet, the adequacy of 100 mg of mepolizumab in disease control is controversial.Objective: To evaluate the sinonasal and respiratory outcomes of EGPA patients treated with 100 mg mepolizumab for one year.Methods: Evaluations of 11 patients were made of the sinonasal outcome test (SNOT-22) (nasal, otologic, sleep, and emotional domains), asthma control test (ACT), forced expiratory volume in 1 s (FEV1), blood eosinophil counts and oral steroid doses before mepolizumab treatment (T0) and at the 6th (T6) and 12th (T12) months.Results: A significant decrease was observed in the total SNOT-22 scores in the 6th month, after which the scores continued to be stable until the 12th month. (SNOT-22 median (IQR); T0: 70(53-82); T6: 19(4-35); T12: 11(6-40); T0-T6, p = 0.02; T6-T12, p = 0.85). In the subdomains of SNOT-22, nasal and sleep-related domains improved significantly in the first 6 months, and the otologic and emotional domains only improved from baseline in the 12th month. There was a significant decrease in blood eosinophil counts in the 6th month and oral steroid dose in the 12th month (eosinophils, median(IQR), T0: 1000(700-1800), T6: 100(0-200), p = 0.02; OCS dose, median(IQR), T0: 16(8-16); T6: 4(0-4); T12: 0(0-4); T0-T12, p = 0.002). A significant improvement was observed in ACT values in the 6th month (ACT median (IQR); T0:16(8-18); T6: 22(21-25); p = 0.01).Conclusion: Mepolizumab 100 mg provided a significant decrease in SNOT-22 values, especially in nasal and sleep domains, eosinophil counts and OCS dose in the 6th month.
Subject(s)
Asthma , Churg-Strauss Syndrome , Granulomatosis with Polyangiitis , Humans , Follow-Up Studies , Granulomatosis with Polyangiitis/drug therapy , Churg-Strauss Syndrome/drug therapy , Asthma/drug therapy , Eosinophils , Steroids/therapeutic useABSTRACT
OBJECTIVES: To investigate the reliability of the OMERACT US Task Force definition of US enthesitis in SpA. METHODS: In this web exercise, based on the evaluation of 101 images and 39 clips of the main entheses of the lower limbs, the elementary components included in the OMERACT definition of US enthesitis in SpA (hypoechoic areas, entheseal thickening, power Doppler signal at the enthesis, enthesophytes/calcifications, bone erosions) were assessed by 47 rheumatologists from 37 rheumatology centres in 15 countries. Inter- and intra-observer reliability of the US components of enthesitis was calculated using Light's kappa, Cohen's kappa, Prevalence And Bias Adjusted Kappa (PABAK) and their 95% CIs. RESULTS: Bone erosions and power Doppler signal at the enthesis showed the highest overall inter-reliability [Light's kappa: 0.77 (0.76-0.78), 0.72 (0.71-0.73), respectively; PABAK: 0.86 (0.86-0.87), 0.73 (0.73-0.74), respectively], followed by enthesophytes/calcifications [Light's kappa: 0.65 (0.64-0.65), PABAK: 0.67 (0.67-0.68)]. This was moderate for entheseal thickening [Light's kappa: 0.41 (0.41-0.42), PABAK: 0.41 (0.40-0.42)], and fair for hypoechoic areas [Light's kappa: 0.37 (0.36-0.38); PABAK: 0.37 (0.37-0.38)]. A similar trend was observed in the intra-reliability exercise, although this was characterized by an overall higher degree of reliability for all US elementary components compared with the inter-observer evaluation. CONCLUSIONS: The results of this multicentre, international, web-based study show a good reliability of the OMERACT US definition of bone erosions, power Doppler signal at the enthesis and enthesophytes/calcifications. The low reliability of entheseal thickening and hypoechoic areas raises questions about the opportunity to revise the definition of these two major components for the US diagnosis of enthesitis.
Subject(s)
Enthesopathy , Humans , Reproducibility of Results , Enthesopathy/diagnostic imaging , Ultrasonography/methods , Ultrasonography, Doppler/methods , InternetABSTRACT
OBJECTIVE: We aimed to compare clinical features, outcomes, treatments, and to define the predictive factors of complete renal response (CRR) in patients with proliferative and non-proliferative lupus nephritis (LN). METHODS: Patients with systemic lupus erythematosus (SLE) followed between 2014 and 2020 at Hacettepe University Hospitals and who had a kidney biopsy were the subject of the study. One hundered and sixteen patients' kidney biopsies reported as LN were evaluated retrospectively. Clinical characteristics and laboratory values at the time of kidney biopsy, histopathological forms of LN, and renal response (complete or partial) were recorded. We analyzed the association between CRR rates during the 2-year follow-up after induction therapy and the predictive factors for CRR. RESULTS: Of 116 (93 females, 23 males) patients, 95 (81.9%) were in the proliferative group (class III and IV) and 21 (18.1%) were in the non-proliferative group (class II and V). In the proliferative group, the percentage of the patients with elevated basal creatinine levels, median daily proteinuria, anti-double-stranded DNA (dsDNA) positivity, low C3 and C4 levels, the presence of active urinary sediment, and median renal SLE Disease Activity Index (SLEDAI) scores at the time of kidney biopsy were significantly higher than the non-proliferative group. Renal response status during the 2-year follow-up after induction therapy was available for 99 patients. During this time, 70 (70.7%) patients had achieved CRR and time-to-CRR was similar between the proliferative and non-proliferative groups (p = 0.64, log-rank test). The Cox proportional hazards model showed that achievement of CRR was associated with female gender [HR: 2.15 (1.19-3.89 95% CI), p = 0.011], newly diagnosed SLE with renal biopsy [HR: 2.15 (1.26-3.67 95% CI), p = 0.005], hypertension [HR: 0.40 (0.27-0.94 95% CI), p = 0.032], eGFR increase [HR: 1.01 (1.00-1.01 95% CI), p = 0.046], and the presence of active urinary sediment [HR: 0.46 (0.22-0.96 95% CI), p = 0.039]. CONCLUSIONS: Achieving CRR was similar in proliferative and non-proliferative LN patients, although certain laboratory parameters differed at the onset. Our results indicated the importance of kidney biopsy in the decision-making of treatment of SLE patients with renal involvement and that the defined factors associated with CRR achievement help to predict good renal response.
Subject(s)
Lupus Erythematosus, Systemic , Lupus Nephritis , Biopsy , Female , Humans , Kidney/pathology , Lupus Erythematosus, Systemic/diagnosis , Lupus Nephritis/pathology , Male , Retrospective StudiesABSTRACT
OBJECTIVES: To compare enteropathic spondylitis (ES) with psoriatic spondylitis (PS) and ankylosing spondylitis (AS), in patients on biological disease-modifying anti-rheumatic drug (bDMARD) treatment. METHODS: Patients who were enrolled in the HUR-BIO registry were included. ES patients were considered as the main study group; AS and PS patients were included as the control groups. ES was defined as patients with inflammatory bowel disease (IBD) having inflammatory back pain/spine symptoms plus radiological sacroiliitis. RESULTS: Sixty-four ES patients (46.9% female), 128 AS patients (39.1% female), and 92 PS patients (62% female) were analysed. Baseline erythrocyte sedimentation rate (ESR) was significantly higher in the ES group than in the AS group. Both the baseline ESR and C-reactive protein were also higher in the ES group compared with the PS group. Among the first bDMARD use, infliximab use was higher in the ES group than the other groups. There was a marginal significant difference between the SpA subgroups in the retention rates of the first bDMARDs (log-rank, p=0.059). Ulcerative colitis was a significant predictor for switching of bDMARDs in comparison to Crohn's disease. Regarding the treatment responses, no significant differences were relevant for the three groups in terms of 50% improvement of the initial Bath Ankylosing Spondylitis Disease Activity Index score, the Assessment of Spondyloarthritis International Society partial remission score, and 20% improvement of ASAS score. CONCLUSIONS: A large majority of enteropathic spondyloarthritis patients on bDMARD treatment had radiographic sacroiliitis. ES patients had distinctive features that distinguish them from AS and PS patients.
Subject(s)
Antirheumatic Agents , Spondylarthritis , Spondylitis, Ankylosing , Antirheumatic Agents/therapeutic use , Biological Factors/therapeutic use , Female , Humans , Male , Registries , Spondylarthritis/drug therapy , Spondylitis, Ankylosing/drug therapyABSTRACT
Background/aim: Gout may cause various radiographic abnormalities such as cartilage loss, spurs, sclerosis, and periostal new bone formation. The purpose of this study was to investigate the frequency of Achilles and plantar spurs and related factors in gout patients. Matherial and methods: We performed a retrospective review of gout patients, treated at Hacettepe University hospitals between 2014 and 2019. We identified patients from the hospital records using the ICD-10 code (M10). Demographic and clinical features, comorbidities, and foot radiographies were collected. The radiographies were evaluated by a rheumatologist (U.K.) who was experienced in musculoskeletal radiography. Factors predicting the spurs were analyzed by logistic regression analysis. Results: 181 patients who had lateral foot radiograph were included in this study. Eighty-one (44.7%) patients had score ≥ 2 Achilles spur, 81 (44.7%) patients had score ≥ 2 plantar spur, and 22 (12.1%) patients had no spur. Age, disease duration, duration between the gout diagnosis and appearing spur, the presence of metabolic comorbidities and hypertension were higher in both Achilles and plantar spurs than no spur group. Forty (22.1%) patients had score ≥ 2 both Achilles and plantar spur. In this group, the mean age was older and the proportion of metabolic comorbidities was higher than the groups of Achilles and plantar spur with a score 0 or 1. Predictor of the development of large or moderate-severe calcaneal spur was the existence of metabolic comorbidity [OR (95% CI): 3.49 (1.1111.0) and p = 0.033]. Conclusion: The presence of metabolic comorbidities increases the frequency of calcaneal spurs in gout patients. This condition can be explained by the impaired microvascular structure and increased hypoxia resulting in calcification on the tendon and ligament insertion sites.
Subject(s)
Achilles Tendon/diagnostic imaging , Gout/epidemiology , Heel Spur/epidemiology , Tendinopathy/epidemiology , Aged , Comorbidity , Female , Heel Spur/diagnostic imaging , Humans , Male , Middle Aged , Radiography , Retrospective StudiesABSTRACT
Background/aim: To assess the real-life efficacy, retention rate, and safety data of tofacitinib in rheumatoid arthritis (RA) patients. Materials and methods: We analyzed all patients registered in the HURBIO database who received at least 1 dose of tofacitinib. Patients who received at least one dose were included in retention analysis; patients with at least 1 control visit were included in efficacy and safety analysis. Factors predicting good response at the last follow-up visit were analyzed by logistic regression analysis. Drug retention rates were calculated using the KaplanMeier method and predictors of drug retention were determined by Cox proportional hazard model. Adverse events, reasons for switching, and discontinuation were also determined. Results: Two hundred and forty-seven (210, 85.0% female) patients were included in the study. The median duration of tofacitinib treatment was 10.2 (20.2) [med, (IQR)] months. Two hundred and four (82.6%) patients were included in safety and efficacy analysis; 45.6% of patients were in low-disease activity (LDA) state (DAS28-CRP ≤ 3.2). Predictors of LDA were being biologic-naïve [aOR 2.53 (1.314.88); 95% CI] and RF negativity [aOR 2.14 (1.124.07); 95% CI]. At 1 year, the overall tofacitinib retention rate was 63.9% with no relevant predicting factor. Response and retention rates of tofacitinib were similar in patients with and without concomitant csDMARDs. Treatment failure was the most common cause of discontinuation. The most common infectious and laboratory adverse events were herpes zoster infection (3.9 per 100 patient-years) and elevation in ALT (x3UNL: 9.7 per 100 patient-years), respectively. Conclusion: Tofacitinib is effective as monotherapy or in combination with csDMARDs. It is a well-tolerated treatment option in Turkish RA patients.
Subject(s)
Arthritis, Rheumatoid , Drug Monitoring , Piperidines , Pyrimidines , Antirheumatic Agents/administration & dosage , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Arthritis, Rheumatoid/epidemiology , Arthritis, Rheumatoid/physiopathology , Drug Monitoring/methods , Drug Monitoring/statistics & numerical data , Drug Therapy, Combination/methods , Duration of Therapy , Female , Herpes Zoster/diagnosis , Humans , Kaplan-Meier Estimate , Longitudinal Studies , Male , Middle Aged , Outcome and Process Assessment, Health Care , Patient Acuity , Piperidines/administration & dosage , Piperidines/adverse effects , Pyrimidines/administration & dosage , Pyrimidines/adverse effects , Treatment Failure , Turkey/epidemiologySubject(s)
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis , COVID-19 , Churg-Strauss Syndrome , Granulomatosis with Polyangiitis , Microscopic Polyangiitis , Humans , Granulomatosis with Polyangiitis/complications , Granulomatosis with Polyangiitis/diagnosis , Churg-Strauss Syndrome/complications , Churg-Strauss Syndrome/diagnosis , Immunosuppressive Agents , Antibodies, Antineutrophil Cytoplasmic , Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/diagnosis , COVID-19 TestingSubject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Humans , Rituximab/adverse effects , Tumor Necrosis Factor Inhibitors/therapeutic use , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Antibodies, Monoclonal, Humanized/adverse effects , Antirheumatic Agents/adverse effects , Treatment OutcomeABSTRACT
OBJECTIVES: We aimed to determine the choice of biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/ts-DMARDs), factors associated with the development of chronic kidney disease (CKD), and mortality in RA patients with CKD receiving b/ts-DMARDs. METHODS: Two thousand one hundred forty-one RA (79.4% female) patients were included in the analysis from the HUR-BIO prospective registry. Patients were divided into the CKD group and the non-CKD group. Age and gender-matched patients were selected from the non-CKD group, and then three main groups were determined. CKD was staged according to the glomerular filtration rate criteria. The clinical characteristics of the patients, disease activities, treatment choices, drug retention rate, and mortality rates were compared between the groups. RESULTS: CKD was detected in 90/2141 (4.2%) RA patients on b/ts-DMARDs. Forty patients (2.3%) developed CKD during follow-up after the initiation of b/ts-DMARDs. In the CKD group, anti-TNF agents were chosen as the first-line b/ts-DMARDs therapy in 64.4% of patients, with etanercept leading in 31 (34.4%) patients. In multivariate analysis, age at the start of treatment, DAS-28-ESR at last visit, amyloidosis, hypertension, and history of smoking were the factors associated with the development of CKD in RA patients receiving b/ts-DMARDs. The mortality rate in RA-CKD patients until the onset of the pandemic was 15.41 per 1000 patient years, whereas it was 85.9 per 1000 patient years after the pandemic. CONCLUSION: Comorbidities and control of disease activity are critical in the development of CKD in RA patients receiving b/ts-DMARDs. While there was no significant difference in mortality rate between CKD and non-CKD patients, the overall mortality rate increased after the COVID-19 pandemic duration in both groups.
Subject(s)
Antirheumatic Agents , Arthritis, Rheumatoid , Biological Products , Renal Insufficiency, Chronic , Humans , Female , Male , Pandemics , Tumor Necrosis Factor Inhibitors/adverse effects , Antirheumatic Agents/adverse effects , Arthritis, Rheumatoid/diagnosis , Arthritis, Rheumatoid/drug therapy , Arthritis, Rheumatoid/epidemiology , Biological Products/adverse effects , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/epidemiologyABSTRACT
OBJECTIVES: i) To explore the agreement between the OMERACT ultrasound lesions of enthesitis and physical examination in assessing enthesitis in spondyloarthritis (SpA) patients; ii) To investigate the prevalence and clinical relevance of subclinical enthesitis in this population. METHODS: Twenty rheumatology centres participated in this cross-sectional study. SpA patients, including axial SpA (axSpA) and psoriatic arthritis (PsA) patients, 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 SpA patients without clinical enthesitis (i.e., number of positive entheses on physical examination and Leeds Enthesitis Index score =0). RESULTS: 4130 entheses in 413 SpA patients (224 axSpA/189 PsA) were evaluated through ultrasound and physical examination. Agreement between ultrasound and physical examination ranged from moderate (i.e., enthesophytes) to almost perfect (i.e., power Doppler and 'active enthesitis'). Patellar tendon entheses demonstrated the highest agreement, whereas Achilles tendon insertion showed the lowest. Among 158/413 (38.3%) SpA patients 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 SpA patients with and without subclinical enthesitis. CONCLUSIONS: Our study underscores the need for a comprehensive tool integrating ultrasound and physical examination for assessing enthesitis in SpA patients.
ABSTRACT
Biosimilars offer cost-effective and safe treatment options both for patients and healthcare systems. CT-P10 is the first biosimilar of rituximab approved in Europe for use in all indications of originator rituximab (oRTX). This study aimed to provide real-life data on treatment changes and adverse events in patients who received oRTX or CT-P10. We retrospectively reviewed treatment-related adverse events [infusion-related reactions (IRRs), infections, hypogammaglobulinemia] in patients treated with at least one dose of oRTX (MabThera®) or CT-P10 (Truxima®) between 2020 and 2021 and had at least 6 months follow-up after rituximab infusion in a rheumatology clinic. The switches between oRTX and CT-P10 were performed according to drug availability at the hospital pharmacy at the time of infusion according to the local hospital procedure. Physicians were not involved in the decision of biosimilar selection. A total of 128 patients (CT-P10, n = 64; oRTX, n = 64) were included. CT-P10 was switched in 52 (40.6%) patients who had previously used oRTX, and 48 (37.5%) patients remained on oRTX. We demonstrated no difference between patients treated with oRTX or CT-P10 in the rates of IRRs, in which all reactions were grade 1 and 2. Comparable rates of infections (p > 0.05) and the rate of hypogammaglobulinemia (p > 0.05) were found in both groups with no significant difference. CT-P10 provides a safe treatment alternative in patients who require rituximab therapy. The rational use of biosimilars can be supported by evolving evidence on interchangeability and switching in real-life settings, which will help clinicians in decision-making.
Subject(s)
Agammaglobulinemia , Biosimilar Pharmaceuticals , Humans , Rituximab/adverse effects , Biosimilar Pharmaceuticals/adverse effects , Agammaglobulinemia/chemically induced , Agammaglobulinemia/drug therapy , Retrospective Studies , Treatment OutcomeABSTRACT
INTRODUCTION: This study aimed to assess the incidence of hematologic malignancy (HM) among inflammatory arthritis (IA) patients receiving tumor necrosis factor inhibitors (TNFi) compared with the general Turkish population. METHODS: HUR-BIO (Hacettepe University Rheumatology Biologic Registry) is a single-center biological disease-modifying anti-rheumatic drug (bDMARD) registry since 2005. Patients with IA, including rheumatoid arthritis, spondyloarthritis, or psoriatic arthritis who had at least one visit after the TNFi were screened from 2005 to November 2021. Standardized incidence rates (SIR) were calculated after adjustment for age and gender and compared with the 2017 Turkish National Cancer Registry (TNCR). RESULTS: Of the 6139 patients registered in the HUR-BIO, 5355 used any TNFi at least once. The median follow-up duration was 2.6 years for patients receiving TNFi. Thirteen patients developed a HM on follow-up. In these patients, the median age at the IA onset was 38 (range, 26-67), and the median age at the HM diagnosis was 55.5 (range, 38-76). Patients using TNFi had an increased HM incidence (SIR 4.23, 95% confidence interval (CI) 2.35-7.05). Ten patients with HM were under 65 years of age. In this group, there was a higher incidence of HM in both men (SIR 5.15, 95% CI 1.88-11.43) and women (SIR 4.76, 95% CI 1.74-10.55). CONCLUSIONS: The risk of HMs in inflammatory arthritis patients receiving TNFi was four times higher than in the general Turkish population.
ABSTRACT
Eosinophilic granulomatosis with polyangiitis (EGPA) is defined the disease as having two subgroups, ANCA (+) and ANCA (-). We aimed to compare EGPA subgroups in terms of clinical features, outcomes, and treatments. A multidisciplinary team was established under our vasculitis centre since October 2014. Totally 50 EGPA patients were enrolled. Clinical features, treatments, and outcomes (FFS, VDI, relapse) were reviewed. For relapse-free survival analysis, time to first relapse was compared according to ANCA phenotype by Kaplan-Meier survival analysis and log-rank test. 17 (34%) patients were in ANCA (+), 33 (66%) patients were in ANCA (-) group. ANCA (-) patients were significantly younger at the diagnosis time (37.9 ± 14.3 vs 53.8 ± 16.3; p = 0.001) and had more nasal polyposis (45.5% vs 11.8%; p = 0.017). ANCA (+) patients had higher BVAS (17[13] vs 9[4]; p = 0.002), renal involvement and peripheral neuropathy were more common in this group, while cardiac involvement was seen only in ANCA (-) group (n = 3). Biological agents (mepolizumab or rituximab) were prescribed to nine patients in ANCA (-) and two patients in ANCA (+) group. The median duration of follow-up was 47 (IQR 69.9) months. ~ 40% of patients had at least one relapse, but relapse-free survival rate was similar between the groups. However, the predictor of first relapse was elevated Ig E level [OR (95% CI): 6.5 (1.09-38.63) p = 0.04]. Consequently, both clinical features, disease activity, and treatments appear to be significantly different between EGPA subgroups. The relapse risk was similar although clinical features and treatment strategies were different. Also, elevated Ig E levels may be a precursor for the relapse.
Subject(s)
Churg-Strauss Syndrome , Granulomatosis with Polyangiitis , Antibodies, Antineutrophil Cytoplasmic , Churg-Strauss Syndrome/diagnosis , Churg-Strauss Syndrome/drug therapy , Granulomatosis with Polyangiitis/diagnosis , Granulomatosis with Polyangiitis/drug therapy , Humans , Recurrence , Turkey/epidemiologyABSTRACT
OBJECTIVES: Psoriatic arthritis (PsA) is an inflammatory musculoskeletal disease related to several comorbidities. Anxiety is an important comorbidity in PsA and the data is scarce. We aimed to understand the rates before biologic agents and change in anxiety with the treatment. METHODS: PsA patients from the Hacettepe University biologic database (HUR-BIO) were assessed for the high anxiety level (score ≥ 4) using the patient self-reported measure of anxiety on a 0-10 numerical scale, included in the Psoriatic Arthritis Impact of Disease questionnaire (PSAID-12). The rate and scores of anxiety were determined before starting biologic agents, at the first visit within 6 months. Changes in anxiety scores were assessed according to favorable treatment responses, and the correlation was evaluated by Spearman correlation analysis. RESULTS: From 520 patients registered, 147 [mean (SD) age 43.3 (12.4) years, 70.7% female] had anxiety score both at baseline and first visit within 6 months. Both the frequency of high anxiety level and mean (SD) scores decreased at the first visit [63.9% vs. 41.4%, 4.8 (3.4) vs. 3.2 (3.1) respectively, p < 0.001 for both] after a mean (SD) follow-up of 105.7 (22.2) days. There was also a positive correlation between the change in anxiety scores and all parameters tested for treatment response: pain, PGA, BASDAI, HAQ-DI, DAS-28, and also PsAID-12. CONCLUSION: Anxiety is a more frequent problem at biologic initiation than rates observed in the general PsA population. The rates show a decreasing trend and correlates with treatment response but is still high within 6 months under treatment. KEY POINTS: ⢠As high as 65% of patients had a high anxiety levels before the initiation of bDMARDs. ⢠The disease activity control is essential in reducing anxiety; however, rates are still high within 6 months. ⢠Decreased anxiety scores and rates of the high anxiety level are linked to better outcomes.
Subject(s)
Antirheumatic Agents , Arthritis, Psoriatic , Biological Products , Adult , Antirheumatic Agents/therapeutic use , Anxiety , Arthritis, Psoriatic/drug therapy , Arthritis, Psoriatic/epidemiology , Biological Products/therapeutic use , Female , Humans , Male , Registries , Severity of Illness IndexABSTRACT
OBJECTIVES: Thrombotic events are common in systemic lupus erythematosus (SLE) and antiphospholipid syndrome (APS). Warfarin is the most commonly used anticoagulant drug for thrombosis treatment, but it is can interact with many drugs, foods, or medicinal herbs. Herein, we presented a case with SLE and APS who was complicated by spinal and cerebral hematoma as a result of warfarin interaction. CASE PRESENTATION: Spinal subdural hematoma and frontal intraparenchymal hematoma were occurred in our patient, who was in remission for 2 years with rituximab, hydroxychloroquine and warfarin. We learned that she had been using some herbal products (shepherd's purse and horsetail) and phenyramidol for a few days. Spinal and cerebral hematomas caused by the interaction of phenyramidol and warfarin were treated with fresh frozen plasma and vitamin K without the need for surgery. CONCLUSIONS: The drug interactions with warfarin can cause fatal hemorrhagic or thrombotic events. Especially, the patients with SLE and/or APS using warfarin should be warned not to use different medications or herbal agents.