Unintentional Monotherapy in Rheumatoid Arthritis Patients Receiving Tofacitinib and Drug Survival Rate of Tofacitinib.

OBJECTIVE: To determine the rate of unintentional monotherapy (UM; switching to monotherapy from combination therapy of patients' own volition) in rheumatoid arthritis patients receiving tofacitinib and to evaluate tofacitinib survival rate. METHODS: This national, multicenter study included patients' data from the TURKBIO Registry. Demographics, clinical characteristics, disease duration and activity, comorbidities, and treatments were analyzed. RESULTS: Data of 231 rheumatoid arthritis patients (84.8% female, median age, 56 years) were included; 153 were initially prescribed combination therapy and continued to their therapies; 31 were initially prescribed combination therapy but switched to monotherapy on their own volition (UM); 21 were initially prescribed monotherapy and switched to combination therapy; 26 were initially prescribed monotherapy and continued to their therapies. The rate of comorbidities at the time of data retrieval was higher in the UM group than in the combination group (83.3% vs. 60.3%, p = 0.031). Presence of comorbidities was a significant factor affecting switching to monotherapy ( p = 0.039; odds ratio, 3.29; 95% confidence interval, 1.06-10.18). The combination and UM groups did not differ regarding remission rate assessed by Disease Activity Score 28-joint count C-reactive protein (60.5% and 70%, respectively; p = 0.328). Drug survival rates of the UM and combination groups did not differ. The median drug survival duration of tofacitinib was 27+ months with 1- and 4-year drug survival rates of 89.6% and 60.2%, respectively, in the UM group. CONCLUSIONS: Although 13.4% of the study population started monotherapy unintentionally, drug survival and remission rates of the UM and combination groups were not different. Comorbidity was a factor affecting transition from combination therapy to monotherapy.

Biological treatment in elderly and young patients with ankylosing spondylitis: TURKBIO real-life data results.

Objectives: This study aims to investigate the effect of age on disease activity and biological treatment in patients with ankylosing spondylitis (AS). Patients and methods: A total of 811 AS patients registered in the TURKBIO registry database between 2011 and 2019 were categorized according to their age at the time of entry into the registry and assigned to one of two groups: young patients, defined as <60 years of age (n=610), and those aged ≥60 years (n=201) were recorded as elderly patients. Demographic, clinical, and laboratory characteristics, along with disease activity markers and other follow-up parameters, as well as current and prior treatments, were electronically recorded during each visit using open-source software. Results: The mean age of the elderly patients was 67±5.8 years, while the mean age of the younger patients was 49.2±10.9 years. Male predominance was lower in the older AS group compared to the younger AS group (p=0.002). During follow-up period, 397 patients (comprising 318 young and 79 elderly individuals) had a history of using at least one biological disease-modifying agent (bDMARD). There was no significant difference between the groups in terms of DMARD and bDMARD-use distributions. First tumor necrosis factor inhibitor (TNFi) retention rates were found to be similar in both groups over 10 years of follow-up. Adverse events were found to be similar in young (19.9%) and elderly (26.8%) AS patients. Conclusion: Research in the TURKBIO cohort reveals that both older and younger patients with AS exhibited similar disease activity levels with comparable treatment approaches. Moreover, the results of TNFi treatments in elderly patients were the same as those observed in younger patients, with no notable increase in safety concerns.

Assessing safety and efficacy of TNFi treatment in late onset ankylosing spondylitis: a TURKBIO registry study.

Clinical data on the use of tumour necrosis factor inhibitors (TNFi) in late-onset ankylosing spondylitis (LoAS) are limited. The present study aimed to evaluate efficacy, safety, and treatment adherence associated with the initial use of TNFi therapy in biologic naive patients diagnosed with LoAS. Patients whose age of onset was ≥ 45 years and < 45 years were classified as having LoAS and YoAS, respectively, based on the age of symptom onset. There were 2573 patients with YoAS and 281 LoAS. Baseline disease activity measures were similar between the groups. No significant differences were seen between the two groups in response to treatment and in remaining on the first TNFi at 6, 12 and 24 months. In the LoAS group, the analysis showed that TNFi discontinuation was linked to VAS pain score (HR 1.04; 95% CI 1.01-1.06). Patient groups had similar rates of adverse events (YoAS: 8.7% vs. LoAS: 11.7%). In both biologic naive LoAS and YoAS patients, the study showed that the initial TNFi therapy was equally effective and safe.

A national, multicenter, secondary data use study evaluating efficacy and retention of first-line biologic treatment with tocilizumab in patients with rheumatoid arthritis in real-life setting: results from TURKBIO registry.

Tocilizumab (TCZ) is a recombinant humanized monoclonal antibody that targets the IL-6 receptor. TCZ found to be efficacious and has a good tolerated safety profile in rheumatoid arthritis (RA) patients. The aim of this study was to describe the disease activity and retention rate in Turkish RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting. Secondary data obtained from adult RA patients' files was used in a multicenter and retrospective context. Clinical Disease Activity Index (CDAI), Disease Activity Score in 28 joints with ESR (DAS28-ESR), and retention rates of TCZ were evaluated at related time points. 130 patients (87.7% female) with a mean age of 53 years (SD; 15.0) were included in the study. Mean RA duration was 14 years and median duration of follow-up was 18.5 months. Number of patients with ongoing TCZ treatment at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (< 2.8) and DAS28-ESR (< 2.6) scores were 61.5, 44.6, 30%, and 54.6, 40.8, 27.7%, respectively. Both CDAI and DAS28-ESR scores significantly improved at 6, 12 and 24 months (p < 0.001 for both). At 24 months, 23 patients (17.6%) discontinued TCZ, of whom majority (17/23) were due to unsatisfactory response. Retention rates of TCZ at 6, 12, and 24 months were 93, 84.3, and 72.2%, respectively. In this real-world study, TCZ as a first-line biologic therapy was found to be efficacious and showing high retention rates. These real-world study results are in line with previous randomized studies.

Predictors of renal and patient outcomes in anti-neutrophil cytoplasmic antibody-associated vasculitis: Our single-center, tertiary care experience.

OBJECTIVES: This study aims to assess the different predictors of renal and patient prognosis in anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) patients with and without renal involvement. PATIENTS AND METHODS: A total of 79 patients (51 males, 28 females; mean age: 57.3±14.2 years; range, 18 to 71 years) with AAV between January 2006 and November 2019 were retrospectively analyzed. Demographic and laboratory data including the complement 3 (C3) serum levels and renal biopsy findings were extracted from the electronic and printed medical records of the hospital registry. Survival, renal survival, remission, and relapse outcomes were analyzed. RESULTS: A total of 35% of the patients with renal involvement progressed to end-stage renal disease (ESRD). The dialysis requirement at the time of admission (hazard ratio [HR]: 21.95 [2.93-164.22]; p=0.003), estimated glomerular filtration rate (eGFR) (HR: 0.97 [0.94-0.99]; p=0.024) and Five-Factor Score (FFS) ≥2 at the time of diagnosis (HR: 3.59 [1.08-11.94]; p=0.037) were the predictors of ESRD. The five-year patient survival rate was 87.1%. The only predictor of mortality was age (HR: 1.07 [1.01-1.14]; p=0.024). The patients with hypocomplementemia (22%) had a lower remission rate (p=0.049), FFS ≥2 at the time of diagnosis (p=0.026), and higher levels of hematuria (p=0.004) and proteinuria (p=0.037). The FFS ≥2 at the time of diagnosis was an independent predictor of relapse (HR: 8.9 [1.02-77.36]; p=0.047). CONCLUSION: Our study suggests that the baseline renal function and FFS ≥2 at the time of diagnosis are the major prognostic factors for progression to ESRD in AAV patients. In addition, AAV patients with hypocomplementemia may have a lower remission rate.

Validation of the Turkish Form of Short Form-12 health survey version 2 (SF-12v2).

OBJECTIVES: In this present study, we aimed to perform the reliability and validity analyses of the Turkish Form of Short Form-12 version 2 (SF-12v2) in different groups of patients. PATIENTS AND METHODS: After the permission for the validation study of the Turkish Form, Optum provided the authors the validly translated Turkish Form of SF-12v2. The study was carried out in rheumatological, psychiatric, and surgical wards of Manisa Celal Bayar University Hafsa Sultan Training and Research Center between September 2019 and June 2020. Taking possible dropouts into consideration, a total of 136 patients (67 males, 69 females; mean age: 43.5±14.4 years; range 19 to 82 years) constituted the study group. In addition to SF-12v2, for concurrent validity, Nottingham Health Profile (NHP) was used as the comparator instrument. RESULTS: In internal consistency, for the physical component summary score, the Cronbach alpha coefficient was 0.80, and item-total score correlation coefficients were between 0.32 and 0.73. The Cronbach alpha coefficient of the mental component summary score was found to be 0.88 where the item-total correlation coefficients varied between 0.60 and 0.78. Exploratory factor analysis revealed a two-factor solution, representing mental and physical components. For criterion validity, convergent and discriminant validity analyses were performed using NHP with SF-12v2, and domains of SF-12v2 correlated well with the domains of NHP accordingly. In criterion validity, the psychiatric group had the lowest mean score in mental health, vitality, social functioning and role difficulties due to emotional problems, whereas the surgical group had the lowest mean score in bodily pain, role difficulties due to physical problems, and physical functioning. CONCLUSION: Our study results show that the Turkish form of SF-12v2 is valid and reliable both in clinical practice and clinical trials.

Low levels of pro-resolving lipid mediators lipoxin-A4, resolvin-D1 and resolvin-E1 in patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is a disease in which joint inflammation is at the forefront but the whole body is affected, and prevention of inflammation is the main treatment approach. Lipoxins (LXs) and resolvins (Rvs) are critical molecules in the resolution of inflammation. In this study, we aimed to investigate the role of LXs and Rvs in the RA pathogenesis. To this end, we measured the LXA 4, RvD 1, RvE 1 levels, and inflammatory cytokines and chemokines IL-6, IL-8, IL-10, IL-17a, IL-22 and MCP-1 in patients with RA and healthy individuals. We found that the LXA4, RvD1, RvE1 levels of the active RA cases were significantly lower than in remission RA and healthy individuals, but the levels of inflammatory cytokines and chemokines were significantly higher. The decreases in LXs and Rvs were independent of disease activity, suggesting that there might be an impairment of LX and Rvs synthesis or catabolism in patients with RA.

Prevalence of Spondyloarthritis Among Patients Who Underwent Lumbar Disc Herniation Surgery.

OBJECTIVES: This study aims to estimate the prevalence of spondyloarthritis (SpA) among patients who had been surgically treated for lumbar disc herniation (LDH), according to the modified New York (mNY) criteria for the diagnosis of ankylosing spondylitis and Amor, the European Spondyloarthropathy Study Group (ESSG), the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for SpA. PATIENTS AND METHODS: The study included 321 patients (142 males, 179 females; mean age 49±10.8 years; range, 18 to 79 years) who underwent LDH surgery between April 2008 and May 2012 in the neurosurgery clinic of our hospital. Patients were contacted by phone on at least two attempts. Totally, 123 patients accepted to come to the outpatient clinic, while the remaining 198 agreed to be interviewed on the phone. Patients who agreed to come to the outpatient rheumatology clinic underwent clinical examination, and pelvic X-ray and magnetic resonance imaging (MRI) scan of the sacroiliac joints when indicated. RESULTS: Inflammatory back pain was diagnosed in 108 patients (34%) and 40 patients (13%) according to Calin criteria and the ASAS criteria, respectively. Prevalence of SpA among all patients was estimated as 17.7% according to the ESSG criteria, and 8.7% according to Amor criteria. Five of the 308 pelvic radiographs had definite radiographic sacroiliitis as required by the mNY criteria. Four patients had a characteristic pattern of bone marrow edema on MRI examination in accordance with the ASAS definitions. The overall prevalence of sacroiliitis (MRI sacroiliitis+X-ray sacroiliitis) among the patients who came to the clinic was 7.3% ([4+5]/123). CONCLUSION: The relatively increased prevalence of SpA among patients who underwent LDH surgery indicates the necessity of increasing awareness on the new concept of axial SpA for specialists treating patients with low back pain.