Glucocorticoid discontinuation rate and risk factors for relapses in a contemporary cohort of patients with giant cell arteritis.

The rates of relapses and therapy discontinuation in patients with giant cell arteritis (GCA) in the modern therapeutic era have not been defined. We aimed to evaluate the glucocorticoid (GC) discontinuation rate and the factors associated with relapses in a contemporary GCA cohort. Patient and treatment data were collected cross-sectionally at first evaluation and 2 years later (second evaluation), in a multicenter, prospective GCA cohort. Predictors of relapses were identified by logistic regression analyses. 243 patients with GCA were initially included (67% women, mean age at diagnosis: 72.1 years, median disease duration: 2 years) while 2 years later complete data for 160 patients were available and analyzed. All patients had received GCs at diagnosis (mean daily prednisolone dose: 40 mg) while during follow-up, 37% received non-biologic and 16% biologic agents, respectively. At second evaluation, 72% of patients were still on therapy (GCs: 58% and/or GC-sparing agents: 29%). Relapses occurred in 27% of patients during follow-up; by multivariable logistic regression analysis, large vessel involvement at diagnosis [odds ratio (OR) = 4.22], a cardiovascular event during follow-up (OR = 4.60) and a higher initial GC daily dose (OR = 1.04), were associated with these relapses. In this large, real-life, contemporary GCA cohort, the rates of GC discontinuation and relapses were 40% and 27%, respectively. Large vessel involvement, a higher GC dose at diagnosis and new cardiovascular events during follow-up were associated with relapses.

Apremilast for biologic-naïve, peripheral psoriatic arthritis, including patients with early disease: results from the APROACH observational prospective study.

To evaluate the effect of the phosphodiesterase 4 inhibitor apremilast in biologic-naïve patients with early peripheral PsA in terms of disease activity, clinical manifestations, patient-perceived outcomes, as well as apremilast's safety profile in routine care settings of Greece. Non-interventional, multicenter, 52-week prospective cohort study, enrolling biologic-naïve patients with early active peripheral PsA who started apremilast after intolerance or inadequate response (within the first 12 months of treatment) to an initial conventional synthetic (cs)DMARD treatment. Non-responder imputation was applied for missing data.In total, 167 consecutive patients (mean age: 52.5 years; median PsA duration: 0.9 years) were analyzed. At baseline, the median (interquartile range) clinical Disease Activity in Psoriatic Arthritis (cDAPSA) score was 22.0 (16.0-29.0), with 86.8% of patients having at least moderate (29.3% high) disease activity; 87.4% had skin psoriasis, 37.7% nail psoriasis, 30.7% enthesitis, and 12.4% dactylitis. At 16, 24, and 52 weeks, 28.7, 42.5, and 48.5% of patients, achieved ≥ 50% improvement in their baseline cDAPSA score, respectively. At week 52, 55.6, 50, and 26.8% of evaluable patients achieved complete resolution of enthesitis, dactylitis and nail psoriasis, respectively. Improvements were also observed in patient's health state assessed by the Psoriatic Arthritis Impact of Disease 12-item questionnaire, and health-related quality of life. The 52-week drug survival rate was 75%, while 13.8% of patients experienced at least one adverse drug reaction.Biologic-naïve patients with early PsA, treated with apremilast experienced significant improvements in disease activity, extra-articular manifestations and patient-centered outcomes, accompanied by a favorable tolerability profile.

A prospective multicenter study assessing humoral immunogenicity and safety of the mRNA SARS-CoV-2 vaccines in Greek patients with systemic autoimmune and autoinflammatory rheumatic diseases.

OBJECTIVES: To investigate humoral responses and safety of mRNA SARS-CoV-2 vaccines in systemic autoimmune and autoinflammatory rheumatic disease (SAARD) patients subjected or not to treatment modifications during vaccination. METHODS: A nationwide, multicenter study, including 605 SAARD patients and 116 controls, prospectively evaluated serum anti-SARS-CoV-2 S1-protein IgG antibody titers, side-effects, and disease activity, one month after complete vaccination, in terms of distinct treatment modification strategies (none, partial and extended modifications). Independent risk factors associated with hampered humoral responses were identified by data-driven multivariable logistic regression analysis. RESULTS: Patients with extended treatment modifications responded to vaccines similarly to controls as well as SAARD patients without immunosuppressive therapy (97.56% vs 100%, p = 0.2468 and 97.56% vs 97.46%, p > 0.9999, respectively). In contrast, patients with partial or without therapeutic modifications responded in 87.50% and 84.50%, respectively. Furthermore, SAARD patients with extended treatment modifications developed higher anti-SARS-CoV-2 antibody levels compared to those without or with partial modifications (median:7.90 vs 7.06 vs 7.1, p = 0.0003 and p = 0.0195, respectively). Mycophenolate mofetil (MMF), rituximab (RTX) and methotrexate (MTX) negatively affected anti-SARS-CoV-2 humoral responses. In 10.5% of vaccinated patients, mild clinical deterioration was noted; however, no differences in the incidence of deterioration were observed among the distinct treatment modification SAARD subgroups. Side-effects were generally comparable between SAARD patients and controls. CONCLUSIONS: In SAARD patients, mRNA SARS-CoV-2 vaccines are effective and safe, both in terms of side-effects and disease flares. Treatment with MMF, RTX and/or MTX compromises anti-SARS-CoV-2 antibody responses, which are restored upon extended treatment modifications without affecting disease activity.

Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

OBJECTIVE: Our aim was to evaluate the effect of adalimumab on work productivity measures, overall activity impairment, and sleep quality in patients with active moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) treated in routine care settings in Greece and determine factors associated with work impairment and sleep disturbance. METHODS: Patients with active moderate to severe RA (n = 184), PsA (n = 166), and AS (n = 150) were enrolled in this 24-month, prospective, observational study at 80 hospital outpatient clinics and private practices throughout Greece. Patients received adalimumab alone or in combination with standard antirheumatic therapies according to routine care. Work productivity and sleep were assessed through two patient-reported outcome measures: the Work Productivity and Activity Impairment-General Health questionnaire and the Medical Outcomes Study Sleep Scale (MOS-SS). Pearson correlation coefficients were estimated to assess the association of work impairment and sleep disturbances with disease activity scores. RESULTS: In the overall population, adalimumab significantly lowered absenteeism [mean (95% confidence interval) reduction, 18.9% (13.3-24.5%); n = 100]; presenteeism [40.0% (33.8-46.3%); n = 98], overall work productivity impairment [46.8% (40.4-53.2%); n = 94], activity impairment [47.0% (44.3-49.6); n = 421], and the MOS-SS sleep problems index [31.6 (29.5-34.1); n = 421] after 24-month treatment (p < 0.001). Significant improvements were also noted across the RA, PsA, and AS subpopulations (p < 0.05). Improvements in overall work impairment and sleep disturbance positively correlated with improvements in disease activity measures. CONCLUSION: Adalimumab improves work productivity and sleep problems while lowering disease activity in patients with moderate to severe RA, PsA, and AS managed in real-world settings.

Nocardia osteomyelitis in an immunosuppressed patient.

Osteomyelitis is an inflammation process of bone caused by a pathogenic microorganism and associated by edema, thrombosis of small vessels and eventually bone necrosis. Infection of bone occurs as a consequence of hematogenous dissemination of bacteria, invasion from a contiguous focuw of infection and skin breakdown. We report a case of lower limbs osteomyelitis due to Nocardia spp in a 68 years old man with Granulomatosis with Polyangiitis (GPA) during his treatment of underlying vasculitis. This case indicates considering rare pathogens in immunosuppressed patients.

Prevalence of symptomatic knee, hand, and hip osteoarthritis in Greece. The ESORDIG study.

OBJECTIVE: To assess the prevalence of symptomatic knee, hand, and hip osteoarthritis (OA) in the general adult population of Greece. METHODS: This cross-sectional population based study was conducted on the total adult population of 7 communities (8547 subjects) and on 2100 out of 5686 randomly selected subjects in an additional 2 communities. Sixteen rheumatologists visited the target population at their homes; an interview based on a standardized questionnaire was conducted and clinical evaluation and laboratory investigations were done, when necessary. ACR classification criteria were used for diagnosing symptomatic OA. RESULTS: Of the final target population of 10,647 subjects, 8740 (82.1%) participated in the study. The age and sex adjusted prevalence of symptomatic knee, hand, and hip OA was 6.0% (95% CI 5.6-6.4), 2% (1.8-2.2), and 0.9% (0.7-1.1), respectively. Symptomatic knee, hand, and hip OA prevalence was significantly higher among women than men and increased significantly with age. Symptomatic knee OA was significantly more common in the rural compared to urban and suburban populations. Logistic regression analysis showed a significant association of female sex and age > or = 50 years with all sites of OA, of obesity with knee and hip OA, and of a low level of education with knee OA. CONCLUSION: Symptomatic knee, hand, and hip OA is common in the general adult population of Greece, showing a female preponderance and a prevalence increasing with age. Female sex and age are risk factors for all sites of OA, obesity for knee and hip OA, and a low level of education for knee OA.

Mortality in systemic sclerosis: an international meta-analysis of individual patient data.

PURPOSE: Studies on mortality associated with systemic sclerosis have been limited by small sample sizes. We aimed to obtain large-scale evidence on survival outcomes and predictors for this disease. METHODS: We performed a meta-analysis of individual patient data from cohorts recruited from seven medical centers in the United States, Europe, and Japan, using standardized definitions for disease subtype and organ system involvement. The primary outcome was all-cause mortality. Standardized mortality ratios and predictors of mortality were estimated. The main analysis was based only on patients enrolled at each center within 6 months of diagnosis (incident cases). RESULTS: Among 1645 incident cases, 578 deaths occurred over 11,521 person-years of follow-up. Standardized mortality ratios varied by cohort (1.5 to 7.2). In multivariate analyses that adjusted for age and sex, renal (hazard ratio [HR] = 1.9; 95% confidence interval [CI]: 1.4 to 2.5), cardiac (HR = 2.8; 95% CI: 2.1 to 3.8), and pulmonary (HR = 1.6; 95% CI: 1.3 to 2.2) involvement, and anti-topoisomerase I antibodies (HR = 1.3; 95% CI: 1.0 to 1.6), increased mortality risk. Renal, cardiac, and pulmonary involvement tended to occur together (P <0.001). For patients without adverse predictors for 3 years after enrollment, the subsequent risk of death was not significantly different from that for the general population in three cohorts, but was significantly increased in three cohorts that comprised mostly referred patients. Analyses that included all cases in each center (n = 3311; total follow-up: 19,990 person-years) yielded largely similar results. CONCLUSION: Systemic sclerosis confers a high mortality risk, but there is considerable heterogeneity across settings. Internal organ involvement and anti-topoisomerase I antibodies are important determinants of mortality.

Prevalence of rheumatic diseases in Greece: a cross-sectional population based epidemiological study. The ESORDIG Study.

OBJECTIVE: To assess the prevalence of rheumatic diseases in Greek urban, suburban, and rural adult general populations. METHODS: This cross-sectional population based epidemiological study of rheumatic diseases in Greece (the ESORDIG Study) was conducted on the total adult population of 2 urban, one suburban, and 4 rural communities (8547 subjects), as well as on 2100 out of 5686 randomly selected subjects in one suburban and one rural community. The study, based on a standardized questionnaire and clinical evaluation and laboratory investigation when necessary, was carried out by rheumatologists who visited the target population at their homes. Either established classification criteria or criteria set for the purposes of the study were used for diagnosis. RESULTS: A total of 8740 subjects participated in the study (response rate 82.1%). The overall age and sex adjusted prevalence (prevalence(asa)) of rheumatic diseases in the total target adult population was 26.9% (95% CI 26.2-27.6), being significantly higher among women (33.7%) than men (19.9%) (p < 0.0005). Disease prevalence(asa) increased significantly with age (p < 0.0005). The most common disease group was low back pain, with a prevalence(asa) of 11.0%, followed by symptomatic peripheral osteoarthritis (7.9%), neck pain (4.8%), miscellaneous rheumatic disorders (4.4%), soft tissue rheumatism disorders (4.3%), and inflammatory rheumatic disease (2.1%). Logistic regression analysis showed a significant positive association of female or male sex, age >or= 50 years, high body mass index, low level of education, moderate or heavy alcohol consumption, and high socioeconomic level with particular diseases or disease groups. CONCLUSION: These findings indicate rheumatic diseases are very common in the general adult population of Greece; 26.9% of adults currently have active or chronic rheumatic disease in remission.