Safety of rituximab in the routine treatment of rheumatoid arthritis in Italy in patients refractory to anti-TNFa drugs: results from the observational retrospective-prospective RUBINO study.

The paper reports the results from the observational retrospective-prospective RUBINO study conducted in Italy to assess the safety of rituximab in the treatment of rheumatoid arthritis (RA) in routine clinical practice. The percentage of patients who manifested at least one grade 3 or 4 adverse event (AE) assessed by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v.3) during the observation period (primary objective) was evaluated. The percentage of patients manifesting a severe AE (SAE), clinical response to rituximab treatment, clinical remission according to disease activity score for 28 joints (DAS28) criteria, markers of disease and quality of life were also assessed. Fifty-three Italian rheumatology centers took part in the study. Patients with a diagnosis of RA and inadequate response to anti-tumor necrosis factor b (anti-TNFa) drugs were enrolled. Participating patients had previously received at least one cycle of rituximab, and treatment was still ongoing at the time of recruitment. Out of 205 patients enrolled, 60% manifested no form of AE, 14.2% had at least one grade 3 or 4 AE, and 11.2% patients reported an SAE. The overall percentage of patients manifesting AEs (40%) was lower compared to the DANCER (81% and 85%), REFLEX (85%) and RESET (85% and 69%) studies, but higher than that observed in the CERERRA registry (from 10.2% to 13.9%). This difference may be due to the shorter observation period applied in the CERERRA registry (only 12 months) compared to the RUBINO study (up to 3 years). All parameters of RA activity (erythrocyte sedimentation rate, C-reactive protein, health assessment questionnaire score, DAS28) improved significantly during the study.

The role of illness perception and emotions on quality of life in fibromyalgia compared with other chronic pain conditions.

OBJECTIVE: Fibromyalgia syndrome (FMs) is a chronic widespread pain condition that can negatively impact on all aspects of patient's life. The purpose of this study was: first, to evaluate illness perception (IP), quality of life (QoL) and affective-emotive variables (EAV) of patients with FM; and second, to compare these variables to different pain conditions. METHODS: Consecutive 34 women (mean age 47.4±8.3 years) affected by FM were enrolled for the study from December 2009 to May 2011. IP was evaluated by means of the Revised Illness Perception Questionnaire, QoL through Nottigham Health Profile and EAV through the Beck Depression Inventory. Scores were compared with rheumatoid arthritis (RA) (n=20; mean age 53±12.8 years) and low back pain (LBP) (n=20; 51.3±7.8 years) groups. RESULTS: FM patients scored higher than RA and LBP groups on IP (Identity scale mean: FM=8.8±2.3, AR=5.5±3.3, LBP=4.1±2.9; Kruskal-Wallis=24.42). Moreover FM patients show higher EAV (mean FM=21±9.6, AR=8.9±5.6, LBP=14.9±6.5; Kolmogorov-Smirnov Z=2.17) and QoL (Pain scale mean: FM=74.2±24.1; AR=35.7±19.9; LBP=56.5±20.4; Kolmogorov-Smirnov Z=2.27; Energy scale mean: FM=86.2±28.5; AR=46.8±35.4; LBP=61.6 ±63.7; Kolmogorov-Smirnov Z=1.98) than RA group. CONCLUSIONS: Our study highlighted dysfunctional IP, low QoL, high EAV scores in FM patients and the significant relations between these variables. Research results provided support for relevance of a multidisciplinary approach to the management of FM, including psychological interventions, according to a biopsychosocial perspective.

[Cardiac tamponade preceding skin involvement in progressive systemic sclerosis]. / Tamponamento cardiaco come manifestazione di esordio della sclerosi sistemica progressiva.

The frequency of pericardial involvement in Systemic Sclerosis (SSc) is high on autoptic or echocardiographic studies, but the clinical recognition of pericarditis with or without effusion is rare. We describe a case of a 71-year-old female with no previous history of heart disease, who presented with a large pericardial effusion and tamponade that required pericardial drain. She had suffered from Raynaud's phenomenon since 25 years. Six weeks after hospital discharge she complained of skin hardening on left leg. Pericardial tamponade is a very rare manifestation of SSc and occurs both early or late in the course of the disease, but in our case it preceded the recognition of scleroderma. We have only identified two other cases of pericardial effusion preceding cutaneous involvement in scleroderma.

[Diagnosis and classification of primary Sjögren syndrome. Comparison of 3 criteria sets in 219 cases]. / Diagnosi e classificazione della sindrome di Sjögren primitiva. Confronto fra tre gruppi di criteri in una casistica di 219 pazienti.

In spite of all recent years' international meetings, the question of diagnostic criteria of primary Sjögren's syndrome (pSS) is still under debate. The aim of our study is to define sensitivity, specificity and diagnostic accuracy of 3 sets of criteria: those of the European Community Study Group (ECSG), those proposed by Fox, and those proposed by Daniels. We considered 219 subjects complaining of dry mouth and/or dry eyes and/or parotid swelling, evaluated for pSS. The following parameters were considered golden standard for the diagnosis of pSS: focus score > or = 2 foci/mm2, double positivity for SSA and SSB antibodies, and a sialographic grade > or = 2. Our study demonstrates that ECSG criteria show a high sensitivity and a good specificity, resulting in a diagnostic accuracy similar, and sometimes higher, than that obtained with Fox and Daniels' criteria.

Thrombosis of the subclavian vein in SAPHO syndrome. A case-report.

The hallmark of SAPHO Syndrome (Synovitis, Acne, Pustulosis, Hyperostosis, Osteitis) is osteitis of the anterior chest wall, which can be so pronounced as to cause thoracic outlet syndrome, thrombosis of the subclavian vein, and compression of the superior vena cava. Suggestive skin manifestations, namely palmoplantar pustulosis and severe acne, generally antedate the bone and joint lesions. We report a case of SAPHO syndrome that went unrecognized for many years and eventually caused compression and thrombosis of the right subclavian vein requiring cleidectomy. SAPHO syndrome should be considered in every patients with anterior chest wall inflammation, particularly when skin lesions are also present.

Thyroid gland disorders in primary Sjögren's syndrome.

OBJECTIVES: To evaluate the frequency of thyroid disorders in primary Sjögen's syndrome. PATIENTS AND METHODS: 121 consecutive patients meeting Vitali's criteria for primary Sjögren's syndrome and 74 with rheumatoid arthritis underwent thyroid hormone assays, tests for antimicrosomal and antithyroglobulin antibodies, tests for antinuclear antibodies and antibodies to extractable nuclear antigens. Antimicrosomal and antithyroglobulin antibodies were also assayed in 404 controls. RESULTS: frequencies were calculated separately in males and females, and data in females were subjected to statistical analysis. As compared with controls, Sjögren's syndrome patients were more likely to have antimicrosomal antibodies (9% versus 17.6%, P < 0.05) and both Sjögren's syndrome and rheumatoid arthritis patients were more likely to have antithyroglobulin antibodies (1% versus 13.4% and 10.9%, respectively, P < 0.0001). Hypothyroidism was more common among Sjögren's syndrome patients (13.4%) than rheumatoid arthritis patients (3.1%) (P < 0.05). Sjögren's syndrome patients with thyroid disorders were less likely to have antinuclear antibodies, rheumatoid factors or a Chisholm's stage 3 or 4 lip biopsy. CONCLUSIONS: our data confirm that thyroid disorders are more common in primary Sjögren's syndrome than in rheumatoid arthritis and controls. Production of autoantibodies and severe histologic lesions were less common in Sjögren's syndrome patients with than without thyroid disorders.

Gynaecological aspects of primary Sjogren's syndrome.

UNLABELLED: Female patients affected with Sjogren's Syndrome (SS) frequently describe symptoms such as vaginal dryness and dyspareunia; however, only a few controlled studies have regarded clinical involvement of the female external genitalia. OBJECTIVE: The present study was undertaken in order to: (1) Evaluate the involvement of external genitalia in a large number of female patients affected with primary SS (pSS) by semi-quantitative methods covering subjective symptoms and clinical evaluation. (2) Compare pSS patients with a matched healthy control group (pre- and post-menopausal women were separately studied). (3) Correlate the gynaecological involvement with salivary and lacrimal abnormalities in pSS patients. METHODS: We evaluated 36 patients with primary SS (18 pre- and 18 post-menopausal women) and 43 healthy controls using a questionnaire regarding vulvar and vaginal dryness and a complete gynaecological examination. Subsequently, three scores related to vulvar and cervical status plus a global score were obtained. In primary SS patients, salivary and lacrimal involvement was also evaluated. RESULTS: Dyspareunia was present in 61% and vaginal dryness in 55% of SS patients versus 39% and 33% of healthy controls. No significant differences regarding gynaecological scores were found between SS patients and controls, in both pre- and post-menopausal women, nor correlation was observed between gynaecological and lacrimal or salivary involvement. CONCLUSIONS: Our data suggest that although SS patients frequently complain of dyspareunia and vaginal dryness they do not greatly differ from healthy subjects in regard to some major gynaecological aspects.