Validation of the Italian version of proposed GRAPPA flare questionnaire for patients with psoriatic arthritis.

OBJECTIVES: The aim of the present study was to validate an Italian version of the GRAPPA flare instrument to identify patients with psoriatic arthritis (PsA) with a possible disease flare. METHODS: This was a cross-sectional study enrolling consecutively PsA patients classified with CASPAR criteria. Inclusion criteria were: age ≥18 years and stable treatment (at least six months of follow-up) with conventional synthetic or biological DMARDs. The flare questionnaire was administered at baseline and within a two-week interval. Internal consistency of the questionnaire was evaluated with Cronbach's alpha coefficient. Construct validity of flare questionnaire was assessed using the correlation between flare score and disease activity indices, HAQ and serum C-reactive protein. Cohen's κ was performed to assess the agreement level between the patient's perception of flare and the score of the questionnaire. Finally, test-retest was performed to assess the reliability of the instrument. RESULTS: 46 PsA patients were enrolled in this study. Of these, 30.4% reported a status of flare of their disease. The questionnaire was internally consistent (alpha=0.81). Moreover, the questionnaire score correlated with the main disease activity indices (Spearman Rho ranging from 0.30 to 0.66; p<0.01). The score of flare questionnaire showed a moderate agreement with the perception of flare from the patients (Cohen's κ=0.54). Test-retest reliability showed a good intra-class correlation. CONCLUSIONS: This initial validation of the Italian version of the GRAPPA flare instrument was favourable. Our results confirm the utility of this questionnaire in the assessment of flare in PsA.

An Assessment of Hand Erosive Osteoarthritis: Correlation of Radiographic Severity with Clinical, Functional and Laboratory Findings.

INTRODUCTION: The present study aimed (a) to evaluate the clinical and radiographic characteristics of hand erosive osteoarthritis (EOA) in a group of consecutive patients, (b) to correlate the severity of radiographic involvement with clinical and laboratory findings and (c) to associate the levels of pain and functional impairment with some radiographic findings. METHODS: Patients with EOA were consecutively enrolled. Inclusion criteria required the American College of Rheumatology (ACR) criteria for hand osteoarthritis and the presence of at least one joint in "E" or "R" phase according to Verbruggen-Veys. For each patient, demographic and clinical data were collected including evaluation of pain and function with the Australian Canadian Osteoarthritis Hand Index (AUSCAN) scale and Health Assessment Questionnaire (HAQ). Laboratory parameters and plain radiography of both hands were also collected. Each radiograph was evaluated in accordance with the Verbruggen-Veys classification and scored with the Kallman score. RESULTS: During the study period 60 patients (M/F 13:47) with EAO were enrolled. More severe radiographic disease ("E" or "R") was often found at II and III distal interphalangeal (IP) joints. In addition, Kallman score, presence of osteophytes, erosions and joint space narrowing correlated significantly with duration of symptoms, AUSCAN, pain and active joints. More severe radiographic involvement was associated with AUSCAN and with the presence of ankylosis only at proximal IP joints. CONCLUSION: The present study showed that EOA is characterised by a significant correlation between radiographic involvement and some clinical characteristics of the disease. However, an impairment of joint function was mainly associated to radiological proximal IP joint involvement, but not with other symptoms such as pain.

Role of comorbidities in spondyloarthritis including psoriatic arthritis.

Spondyloartrhitis (SpA) are a group of diseases characterized by inflammation at articular and entheseal sites. Moreover, patients with SpA suffer from impaired articular function and reduced quality of life. Beyond the articular involvement, SpA and in particular psoriatic arthritis (PsA) are associated with extra-articular manifestations and comorbidities that might increase the burden of the disease. The aim of this article was to review the available evidences on the presence of comorbidities in SpA, including PsA, focusing the attention on the cardiovascular, metabolic aspects, as well as other comorbidities, and their possible management in an integrated manner. Comorbidities in SpA should be carefully evaluated because of their important impact.

Unmet Needs in Axial Spondyloarthritis.

During the past decade, the well-known disease called ankylosing spondylitis has come to be considered as a subset of the broader entity referred as axial spondyloarthritis (axSpA), which also includes non-radiographic axSpA. The need of this new classification was aimed to improve the sensitivity for an early diagnosis, to reduce diagnostic delay, and to allow an early treatment. Although there is improvement in the recognition, the management of patients, and the treatment strategies of axSpA, unmet needs persist. There is still a substantial gap of 5-8 years between the onset of symptoms and the diagnosis of axSpA and, even in patients diagnosed early, 20-40% of them do not respond or have a loss of response to anti-TNF treatment. Moreover, the pathogenesis of the disease and, in particular, the mechanisms of new bone formation are far to be completely understood. Nevertheless, the discovery of IL-23/IL-17 axis with the development of biologic inhibitors, the identification of new subsets of effector cells, together with the interest in the detection of potential biomarkers of bone formation brought the approach to axSpA into a new era. This review is intended to enhance awareness and understanding of axSpA and to identify and discuss the current unmet needs in axSpA, including diagnosis, classification, biomarkers, pathogenesis, management, and treatment strategies.

Residual disease activity in rheumatoid arthritis patients treated with subcutaneous biologic drugs that achieved remission or low disease activity: a longitudinal observational study.

The aim of this study was to evaluate the residual disease activity (RDA) and function in rheumatoid arthritis (RA) patients treated with subcutaneous biologic drugs that achieved a status of remission and low disease activity (LDA) according to the various indices validated for RA and to explore the factors associated with RDA. We consecutively enrolled RA patients that started a new subcutaneous biologic treatment. At baseline and after 3 and 6 months of treatment, we assessed the rate of patients that achieved remission or LDA using the Disease Activity Score on 28 joints, Clinical Disease Activity Index, Simplified Disease Activity Index, and American College of Rheumatology/European League Against Rheumatism remission criteria. The presence of RDA was evaluated as the rate of patients with at least tender joint count > 1, swollen joint count > 1, pain on VAS > 10 mm, general health (VAS) > 10, patient's disease activity (VAS) > 10, physician disease activity (VAS) > 10, and C reactive protein > 1 mg/dl. We also evaluated the impaired function defined as HAQ score > 0.5. Factors associated to RDA were also investigated. Ninety-three adult patients with RA were enrolled. At 6 months, RDA occurred mostly at the level of Patient's reported outcome items and less frequently in tender and swollen joints and acute-phase reactants. Interestingly, about one fourth of patients in LDA and up to one fifth of patients in remission had residual functional impairment with an HAQ score greater than 0.5. RDA in RA was present even in patients with remission or LDA, especially for the patient's reported outcome. Impaired function was also present in a significantly rate of patients.

From clinical remission to residual disease activity in spondyloarthritis and its potential treatment implications.

INTRODUCTION: Remission or low disease activity should be the target of therapy in spondyloarthritis (SpA). Due to the complexity of the disease, several composite indices that assess all disease domains were proposed to define a status of low disease activity/remission in both axial and peripheral SpA. With the introduction, in the past years, of effective biologic and targeted synthetic treatments aimed at inhibiting key cytokines and intracellular pathways, the goal of clinical remission has become an achievable target in these conditions. However, residual disease activity may occur in some domains and the management of patients that achieve the target of remission is still an unmet need. Areas covered: This manuscript aimed to review the current evidence on clinical remission and residual disease activity in SpA (both axial SpA and psoriatic arthritis), and its potential treatment implications. Expert commentary: Progress in our understanding of the pathogenesis of SpA will lead to a rapid increase in the number of available treatments, with the possibility for patients to achieve a status of remission. However, the topic of residual disease activity should be taken into consideration.

Incidence of rheumatoid arthritis, psoriatic arthritis and polymyalgia rheumatica in an inland area of central Italy: results of the CAMPO-RHE study.

OBJECTIVE: The aim of the CAMPO-RHE study was to determine the incidence of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and polymyalgia rheumatica (PMR) in patients attending a rheumatologic outpatient's clinic of a new institution in Campobasso, Italy. METHODS: Campobasso is a small town of approximately 50,000 inhabitants located in the inland territory of central Italy (Molise), and Public Health is managed from a single health authority. In Italy, all citizens are registered with a National Health System of General Practitioner (GP) Physicians. Between the 1st of June 2014 and the 31st of May 2016, all consecutive adult patients, sent by a GP, of Campobasso with any diagnosis of musculoskeletal symptoms/signs/complaints were evaluated in a single rheumatology outpatient clinic of our Academic Unit. The clinic represents the first and unique reference for GPs about rheumatic diseases in the territory. Subjects were classified using the 2010 EULAR criteria for RA, the CASPAR criteria for PsA and the 2012 ACR classification criteria for PMR. RESULTS: 1003 adult patients, sent by GPs, with articular or musculoskeletal complaints visited our clinic. Of these, 409 inhabitants of the municipality of Campobasso were evaluated for the study. During the 2-year study period we diagnosed 18, 19 and 12 new cases of RA, PsA and PMR respectively, with a new incident cases rate of 21.4, 22.59 and 27.43/100,000/year on the population at risk. CONCLUSION: The results of our study could contribute to better define the incidence of these rheumatic diseases classified with the new classification criteria.

Serum Sclerostin as a Possible Biomarker in Ankylosing Spondylitis: A Case-Control Study.

OBJECTIVE: Several molecules are involved in the pathogenesis of a new bone formation in ankylosing spondylitis (AS). The aim of this study was to evaluate the serum levels of sclerostin in patients with AS as a possible biomarker and to investigate any correlations with radiographic damage, disease activity, and function. METHODS: AS patients fulfilled the modified New York criteria, and healthy controls were enrolled for this study. BASDAI, ASDAS-CRP, BASMI, BASFI, patient and physician VAS, and C-reactive protein were evaluated at baseline visit. Spinal damage was assessed using the mSASSS on radiographs performed within 3 months from baseline. Serum concentrations of sclerostin were assessed at baseline and after four months of therapy in patients who started an anti-TNF. RESULTS: Twenty healthy subjects and 40 AS patients were enrolled in the study. In our group, serum sclerostin levels (median (25th-75th percentile)) were significantly higher in healthy controls (18.04 (13.6-24) pg/ml) than in AS patients (6.46 (4.5-11.1) pg/ml; P value < 0.01). However, no significant correlations were found between serum sclerostin levels and radiographic damage, assessed by mSASSS, and between serum sclerostin levels and clinical indices of activity and disability or with laboratory parameters. Sclerostin levels did not show significant changes after 4 months of anti-TNF therapy. CONCLUSIONS: The results of our study suggest a possible role of sclerostin in the identification of AS patients. Further studies are needed to prove the role of sclerostin as a disease activity biomarker and progression of disease in AS.

Comparison of Composite Indices Tailored for Psoriatic Arthritis Treated with csDMARD and bDMARD: A Cross-sectional Analysis of a Longitudinal Cohort.

OBJECTIVE: In a complex disease such as psoriatic arthritis (PsA), several methods are available to define remission or low disease activity (LDA), including the assessment of different clinical features. The aim of this study was to compare the composite indices tailored for PsA in patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARD) and biological DMARD (bDMARD). METHODS: Patients with PsA classified with the ClASsification criteria for Psoriatic ARthritis criteria and with > 6 months followup treated with first csDMARD and bDMARD were consecutively enrolled. To assess disease activity, composite indices tailored for PsA were used, such as the Disease Activity Index for Psoriatic Arthritis (DAPSA), clinical DAPSA (cDAPSA), Psoriatic Arthritis Disease Activity Score (PASDAS), minimal disease activity (MDA) 5/7, and MDA 7/7. DAPSA and cDAPSA score ≤ 4, MDA 7/7, and PASDAS ≤ 1.9 identified remission. MDA 5/7, DAPSA score ≤ 14, cDAPSA score ≤ 13, and PASDAS < 3.2 identified the MDA and LDA criteria. RESULTS: One hundred nine patients with PsA were enrolled: 79 patients were receiving stable treatment with bDMARD and 30 with csDMARD. Overall, 28 (25.6%), 23 (21.1%), 19 (17.4%), and 13 patients (11.9%) were in cDAPSA remission, DAPSA remission, MDA 7/7, and PASDAS ≤ 1.9, respectively. Moreover, 54 (49.5%), 80 (73.3%), 79 (72.3%), and 38 patients (34.8%) were in MDA 5/7, DAPSA LDA, cDAPSA LDA, and PASDAS LDA. Patients treated with bDMARD had significantly lower median DAPSA, cDAPSA, and PASDAS score than patients treated with csDMARD. CONCLUSION: Patients with PsA receiving bDMARD are more likely to achieve a status of MDA and remission when compared with csDMARD. PASDAS ≤ 1.9 and MDA 7/7 seem to be stringent remission criteria.