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"Nacci, F."
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POS1388-HPR RELATIONSHIP BETWEEN CENTRAL SENSITIZATION AND PSYCHOLOGICAL FACTORS IN RHEUMATOID ARTHRITIS: A CROSS-SECTIONAL, MULTICENTER STUDY
2023
BackgroundAffective distress (clinically significant depression, anxiety and stress) and central sensitization (CS) are consistently associated with the reported sensitivity and severity of pain, physical disability, poor treatment outcomes, and inflammatory disease activity, and potentially with early mortality in rheumatoid arthritis (RA).ObjectivesWe aimed to explore affective distress in patients with RA and determine how they connected to CS.MethodsUsed the CSI to measure CS and the Depression, Anxiety and Stress Scale - 21 Items (DASS-21) to evaluate the negative emotional states of depression, anxiety and stress. The total CSI score ranges from 0 to 100, and a score of 40 or greater has been established to indicate CS. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Multiple regression analysis was used to find out which factors were most likely to be linked to CS.ResultsOverall we included 192 RA patients (age ranging from 22 to 86 years) with a mean disease duration of 5.95 (SD 13.75) years. The CSI score was ≥ 40 in 70/192 patients (36.5%). In our RA cohort, the DASS-21 total score was 32.3 (SD29.8). The mean Anxiety score (Mean=10.68 and SD=8.92 was in the moderate range (10-14), whereas the mean Depression (Mean = 10.11 and SD = 11.66) and Stress (Mean = 15.8 and SD=12.05) scores were in the mild range (10-13 and 15-18, respectively). In the 70 patients with CSI score > 40, the mean Anxiety score (Mean=12.20 and SD=10.01) and the mean Depression (Mean = 14.01 and SD = 13.83) and Stress (Mean = 19.51 and SD=12.77) scores were all in the moderate range (10-14, 14-20 and 19-25, respectively).ConclusionAffective distress symptoms (clinically significant depression, anxiety and stress) and CS are common in RA patients. Screening and recognition of such psychosocial disorders may help patients achieve optimal disease control and a good outcome. Overall, our findings have implications for health policy and emphasize the significance of identifying high-risk fibromyalgia (FM) patients by monitoring CS as an indicator of severe disease.References[1]Bottesi G, Ghisi M, Altoè G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81.[2]Ruhaila AR, Chong HC. Self-reported symptoms of depression, anxiety and stress among patients with Rheumatoid Arthritis in a Malaysian rheumatology centre - prevalence and correlates. Med J Malaysia. 2018 Aug;73(4):226-232.[3]Bacconnier L, Rincheval N, Flipo RM, Goupille P, Daures JP, Boulenger JP, Combe B. Psychological distress over time in early rheumatoid arthritis: results from a longitudinal study in an early arthritis cohort. Rheumatology (Oxford). 2015 Mar;54(3):520-7.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
Journal Article
POS0992-HPR THE EFFECT OF CENTRAL SENSITIZATION ON DISEASE SEVERITY LEVELS AND PRESENTEEISM-RELATED PRODUCTIVITY LOSS IN FEMALE WORKERS WITH RA
2023
BackgroundPatients with RA experience a decline in health-related quality of life, which is associated with increased illness severity and impairment of work abilities. Central sensitization (CS) emerges as an accurate predictor and correlate of poor pain experience.ObjectivesThe purpose of this cross-sectional, multicentric study is to investigate the mediating role of CS in unfavorable relationships with disease activity levels, CS and work productivity loss due to presenteeism in women with RA, with the goal of identifying potential new targets for preventive interventions.MethodsThe study used a cross-sectional design and included 101 female workers with RA classified according to 2010American College of Rheumatology (ACR)/Europenan League Against Rhumatisms (EULAR) classification criteria. All patients filled out the italian version of the RAID, an assessment and evaluation tool that measures RA patient disease activity, progress, and outcomes. The Central sensitization Inventory (CSI) was used to measure CS, and the Work Productivity and Activity Impairment questionnaire-RA (WPAI-RA) was used to evaluate patients’ employment status. RA patients were grouped into categories, based on their RAID total score. Multiple regression analysis was used to find out which factors were most likely to presenteeism.ResultsThe patients’ age ranged from 25 to 65 years, with a disease duration of 5.4 (SD 6.1) years. The CSI score was ≥ 40 in 39/101 patients (38.6%). 70 patients (69.3%) worked full-time, while 31 (30.7%) worked part-time. The majority of respondents (64.5%) reported a high degree of presenteeism with an average level of 31.8%. On the other hand, absenteeism was uncommon, with just 7.3% of respondents reporting it. %. Presenteeism was associated with higher CSI score (0.049), increased disease activity (0.0007), disease duration (0.0072) and age (0.0019) (Table 1).ConclusionCS disease activity and age were the factor most significantly associated with presenteeism-related productivity loss in RA patients. our findings have implications for health policy and emphasize the significance of identifying high-risk RA patients by monitoring CS as an indicator of presenteeism and severe disease activity.References[1]Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993;4:353–365.[2]Salaffi F, Di Carlo M, Vojinovic J, Tincani A, Sulli A, Soldano S, Andreoli L, Dall’Ara F, Ionescu R, Simić Pašalić K, Balčune I, Ferraz-Amaro I, Tlustochowicz M, Butrimienė I, Punceviciene E, Toroptsova N, Grazio S, Morović-Vergles J, Masaryk P, Otsa K, Bernardes M, Boyadzhieva V, Cutolo M. Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis. Joint Bone Spine. 2018 May;85(3):317-322.[3]Sakai R, Tanaka E, Inoue E, Sato M, Tanaka M, Ikari K, Yamanaka H, Harigai M. Association between patient-reported outcomes and impairments in work and activity in patients with rheumatoid arthritis in clinical remission: a retrospective analysis using the IORRA database. Mod Rheumatol. 2022 Sep 12:roac105. doi: 10.1093/mr/roac105. Epub ahead of print. PMID: 36094815.Table 1.Multiple Regression Equation: Coefficients, Standard Errors and p valuesIndependent variablesCoefficientStd. ErrortP(Constant)39.8907mRDCI comorbidity score0.10490.16090.6520.5153DASS-210.069350.084910.8170.4151CSI score2.88301.26401.9940.0498ROAD score0.80981.38990.5830.5609RAID score4.47371.29033.4670.0007Kihon score-0.39210.5589-0.7020.4838Age, yrs-0.66240.2100-3.1550.0019Disease duration-0.035420.01303-2.7190.0072Acknowledgements:NIL.Disclosure of InterestsNone Declared.
Journal Article
OP0012-HPR CENTRAL SENSITIZATION HAS MAJOR IMPACT ON DISEASE ACTIVITY, FUNCTIONAL DISABILITY AND FRAILTY IN PATIENTS WITH RA
2023
BackgroundCentral sensitization (CS) assessed with Central sensitization Inventory (CSI) is significantly associated with functional disability and frailty in patients with rheumatoid arthritis (RA). Frailty is common in RA and associated with hospitalization and mortality. Frailty in RA is dynamic and, for some, may be ameliorated through controlling disease activity and functional disability.ObjectivesOur aim was to investigate the prevalence of CS in patients with RA and its association with measures of disease activity, functional disability, and frailty.MethodsWe administered to all the subjects in the study the CS inventory (CSI), a questionnaire that has been used for the diagnosis of CS. Demographic and clinical characteristics were collected as well as measures of disease activity [RAID), functional disability (ROAD) and Kihon Checklist (KCL) screening tool to identify community-dwelling adults vulnerable to frailty potentially at risk of becoming dependent. Patients with fibromyalgia were excluded from the study.ResultsOf the 192 included RA patients, mean CSI score was 36.7 ±15.5 and 36.5% scored >40, which indicates a high probability of CS. Mean CDAI score was 16.8 ± 12.4 and mean RAID 5.0 ± 2.0. A CSI score >40 was significantly associated with higher RAID (mean 5.7 vs. 4.6; F-ratio 12.28; p=0.001), higher ROAD (mean 4.3 vs. 3.0; F-ratio 17.37; p<0.001) and higher Kihon score (mean 9.1 vs. 5.7; F-ratio 29.88; p<0.001).ConclusionCS is strongly related to patient-reported disease activity, functional disability and frailty in patients with RA independently from other patient-and disease-related aspects. CS is an important determinant of functional disability in patients with chronic inflammatory arthritides. Therefore, special attention should be paid to RA patients, in whom the concomitant diagnosis of CS should be routinely ruled out.References[1] Chiarotto A, Viti C, Sulli A, Cutolo M, Testa M, Piscitelli D (2018) Cross-cultural adaptation and validity of the Italian version of the Central Sensitization Inventory. Musculoskelet Sci Pract 37:20-28.[2] Salaffi F, Di Matteo A, Farah S, Di Carlo M: Inflammaging and Frailty in Immune-Mediated Rheumatic Diseases: How to Address and Score the Issue. Clin Rev Allergy Immunol 2022; doi: 10.1007/s12016-022-08943-z.[3] Watanabe D, Yoshida T, Watanabe Y, Yamada Y, Miyachi M, Kimura M: Validation of the Kihon Checklist and the frailty screening index for frailty defined by the phenotype model in older Japanese adults. BMC Geriatr 2022; 22:478.[4] Salaffi F, Stancati A, Neri R, Grassi W, Bombardieri S. Measuring functional disability in early rheumatoid arthritis: the validity, reliability and responsiveness of the Recent-Onset Arthritis Disability (ROAD) index. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S31-42.Figure 1.Disease activity (RAID score), functional disability (ROAD score) and frailty (Kihon score) in patient with CSI < 40 (n° 122) and CSI > 40 (n° 70).Acknowledgements:NIL.Disclosure of InterestsNone Declared.
Journal Article
AB0477 EFFICACY AND SAFETY OF UPADACITINIB IN RHEUMATHOID ARTHRITIS: REAL-LIFE EXPERIENCE FROM A MULTICENTRIC ITALIAN STUDY
2023
Upadacitinib (UPA), a JAK inhibitor engineered for a greater selectivity towards JAK1, has demonstrated a favourable benefit-to-risk profile in rheumatoid arthritis (RA) patients with an inadequate response to cDMARDs and biologic agents in randomized clinical trials. However, real-life data on its efficacy and safety are limited. We herein provide the first prospective multicentre experience on UPA efficacy and safety profile in RA in a real-life context, focusing on clinimetric and ultrasonographic (US) data.
The primary aim of the study was to assess changes in clinimetric and US scores between different time point observations (baseline, 1 month, 3 months and 6 months). Secondary aims were to: (i) estimate the impact of biologic line of treatment and of concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; (iii) find potential predictive factors associated with response to therapy.
Medical records of consecutive RA patients treated with UPA and referred to three Italian tertiary Centers were prospectively reviewed. Adult patients meeting ACR/EULAR classification criteria for RA were enrolled.
Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation. An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time.
In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs.
Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice.
Our real-life experience confirms the efficacy in terms of clinical and US improvement as well as displaying a good safety profile. The combination therapy with a conventional immunosuppressants predicts a significantly lower clinical and US improvement, likely reflecting a more severe and aggressive course worthy of ad-hoc and more in-depth investigation.
An improvement in the SDAI and DAS28CRP was observed, already from the first month of therapy and has been maintained over time.
In conclusion, these results demonstrated the short term efficacy of Upadacitinib 15 mg for up to 6 months and providing a prompt improvement of PROs.
Even if further studies are needed to clarify those results, these novel findings may provide new insight for the management of UPA treatment in clinical practice.
NIL.
NIL.
None Declared.
[Display omitted]
Table 1Changes in clinimetric and ultrasonographic scores throughout the study period and significance levels (p values) for single comparisons between different observations in time.EndpointOverall significanceT0 vs T1T0 vs T3T0 vs T6T1 vs T3T1 vs T6T3 vs T6Synovitis grade< 0.0010.8040.090<0.001< 0.001< 0.001< 0.001PD signal grading0.0290.9140.3200.0260.0290.0090.066Tenosinovitis grading0.0120.9680.3700,0310,0180,0090,059DAS28-CRP0.0050.014< 0.001< 0.0010.2200.0150.035SDAI index< 0.0010.003< 0.001< 0.001< 0.001< 0.001< 0.001List of abbreviation: DAS28-CRP Disease Activity Score 28 – C-reactive protein, PD power Doppler, SDAI Simplified Clinical Activity Index, T0 baseline, T1 1 month evaluation, T3 3 month evaluation, T6 6 month evaluation
Journal Article
Rheumatic diseases in migrant patients resident in Tuscany: epidemiological data analysis and single-center experience
by
Matucci-Cerinic, M.
,
Bellando-Randone, S.
,
Nacci, F.
in
Chronic illnesses
,
Connective Tissue Diseases
,
epidemiology
2024
Objective. In the last decades, the number of foreigners in Tuscany has considerably increased with a multiethnic distribution. We reviewed the main rheumatic diseases in the foreign population resident in Tuscany and also reported the experience at the Rheumatology Division of the University Hospital of Careggi, Florence, in order to identify the areas of origin of these patients and the main rheumatic diseases observed in them. Methods. The collaboration with the Tuscan Region provided data about foreign patients residing in Tuscany on January 1, 2021 (country of origin, chronic diseases). Moreover, we conducted a retrospective review of the clinical charts of our Rheumatologic Division from January 1, 2019, to December 31, 2020. Results. In Tuscany, on January 1, 2021, there were 61,373 patients with chronic inflammatory rheumatic diseases, and 3994 of them (6.51%) were foreigners. Most patients were born in Europe (39.03%), followed by the Balkans (15%), South America (11.27%), and North Africa (10.31%). Inflammatory joint diseases, Sjögren syndrome, and systemic lupus erythematosus were the most frequent diseases. In the period 2019-2020, 511 foreign patients visited our Rheumatology Division and mainly originated from the Balkans (34.64%), South America (18%), and European countries (16.44%). In these patients, chronic inflammatory joint diseases and connective tissue diseases (systemic sclerosis, Sjögren syndrome, and systemic lupus erythematosus) were the most prevalent diseases. Conclusions. This study provides a picture of the rheumatic diseases affecting foreign patients residing in Tuscany that are in agreement with the epidemiological data previously provided.
Journal Article
AB0716 FIBROMYALGIA SYNDROME SEVERITY ACCORDING TO AGE CATEGORIES: RESULTS FROM A NATIONAL REGISTER
2021
Fibromyalgia syndrome (FM) is characterised by a complex symptom spectrum, dominated by the presence of chronic widespread pain, fatigue and unrefreshing sleep. FM affects between 2 and 3% of the general population. It is a condition that mainly involves middle-aged women, although it is increasingly being diagnosed in younger people. The severity of symptoms can vary greatly between individual patients, and is influenced by many factors (e.g. sex, body mass index) [1]. To date, there is little information about changes in severity in accordance with patient age.
The aim of this study was to investigate variations in symptom severity in FM patients according to age categories.
A cross-sectional study of adult FM patients diagnosed according to the American College of Rheumatology 2010/2011 criteria was performed. The case series was included from an Italian national registry [2]. Patients were grouped according to five age categories: 18-40 years, 41-50 years, 51-60 years, 61-70 years, over 71 years. Symptom severity was assessed through the revised Fibromyalgia Impact Questionnaire (FIQR) and domains, including FIQR physical function (items 1-9), FIQR health status (items 10-11), and FIQR symptoms (items 12-21). Between-group characteristics were analysed using one-way analysis of variance (ANOVA).
This study included a total of 2889 patients, 403 aged 18-40 years, 756 aged 40-50 years, 1035 aged 50-60 years, 528 aged 60-70 years, and 167 over 70 years, respectively. The mean (standard deviation [SD]) score of the total FIQR was 52.68 (11.82). Total FIQR and individual domains all showed a normal distribution. Analysing the data by age category, there were statistically significant differences between the categories for the total FIQR (p = 0.030). The age categories with the highest disease severity were those above 71 years (FIQR 62.14, SD 22.45), and between 51-60 years (FIQR 60.31, SD 22.89) (Table 1). Significant differences between age categories were also found for the domains physical function (p = 0.006) and health status (p = 0.012), but not for the domain symptoms (p = 0.164).
Distinguishing the disease severity in FM patients according to age categories, a bimodal distribution emerges, with the disease severity being greatest in patients over 71 years and in the 51-60 years decade. The main differences in severity, according to what can be detected through the FIQR, are attributable to the domains physical function and health status, which show higher scores in the two classes with higher severity.
[1]Sarzi-Puttini P et al., Fibromyalgia: an update on clinical characteristics, aetiopathogenesis and treatment. Nat Rev Rheumatol 2020; 16: 645–660.
[2]Salaffi F et al., The Italian Fibromyalgia Registry: a new way of using routine real-world data concerning patient-reported disease status in healthcare research and clinical practice. Clin Exp Rheumatol 2020; Suppl 123: 65-71.
Società Italiana di Reumatologia (SIR) and Italian Ministry of Health
None declared
Table 1Mean values of FIQR total score and domains according to age categories.FIQR and domains18-40 years41-50 years51-60 years61-70 years≥71 yearsp*FIQR total, mean (SD)57.90 (21.76)59.25 (23.30)60.31 (22.89)57.13 (23.59)62.14 (22.45)0.030FIQR physical function, mean (SD)15.51 (7.56)16.44 (7.77)16.77 (7.51)15.96 (7.82)17.68 (7.26)0.006FIQR health status, mean (SD)11.19 (5.85)11.24 (5.99)11.49 (5.93)10.57 (6.11)12.21 (5.97)0.012FIQR symptoms, mean (SD)31.32 (10.48)31.56 (11.32)32.10 (11.01)30.68 (11.47)32.24 (11.34)0.164Abbreviations and legend. FIQR = revised Fibromyalgia Impact Questionnaire; SD = standard deviation; * = one-way analysis of variance (ANOVA).
Journal Article
AB0467 EFFECTIVENESS OF GOLIMUMAB AFTER TNF-INHIBITOR FAILURE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, OR AXIAL SPONDYLOARTHRITIS: RESULTS AT 3 MONTHS FROM THE GO-BEYOND ITALY STUDY
by
Matucci-Cerinic, M.
,
Perricone, R.
,
Santo, L.
in
Ankylosing spondylitis
,
C-reactive protein
,
Dyslipidemia
2021
Golimumab showed trial efficacy in subjects with active rheumatoid arthritis (RA) previously treated with TNF-inhibitors (TNFi); no trial data are available for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).
To assess the effectiveness of golimumab after TNFi failure in patients with RA, PsA, or axSpA in a real-world setting.
GO-BEYOND-Italy is an ongoing, multicenter, prospective, observational study of RA, PsA, or axSpA patients starting golimumab after TNFi failure. Patients were enrolled between July 2017 and December 2019, and followed for 1 year, with evaluations at 3, 6, and 12 months. This interim analysis estimates the effectiveness after 3 months of golimumab therapy. Differences from baseline were tested by paired t-tests.
193 patients were enrolled: 38 (19.7%) with RA (median age 54 years; median disease duration 9.5 years), 91 (47.2%) with PsA (median age 53 years; median disease duration 9.0 years) and 64 (33.2%) with axSpA (median age 54 years; median disease duration 7.2 years). Majority of the RA (73.7%), PsA (51.6%) and axSpA (53.1%) were females. Previous TNFi treatment included etanercept (44.6% of patients), adalimumab (42.0%), infliximab (8.8%) and certolizumab (4.7%). The main reason for switching to golimumab was loss of efficacy of TNFi (78.9% in RA, 83.5% in PsA, 75% in axSpA). Comorbidities were highly prevalent (RA 65.8%, PsA 65.9%, axSpA 75%); hypertension (31.1%), dyslipidaemia (13.5%), fibromyalgia (10.4%) were the most common ones. DAS28-CRP significantly reduced in RA and PsA (p<0.01) after 3 months of treatment. In RA, rates of DAS28-CRP remission and low disease activity (LDA) were 29.6% and 22.2%, respectively, and 65.2% of patients achieved good/moderate EULAR response. As for PsA, good/moderate EULAR response was observed in 78.8% of patients and 28% of patients achieved minimal disease activity. In axSpA, ASDAS-CRP (p<0.01), BASDAI (p<0.01) and ASAS-HI (p=0.032) significantly reduced; rates of ASDAS-CRP inactive disease and LDA were 15.2% and 26.1%, respectively; 14% of patients had a ≥50% improvement in baseline BASDAI. After 3 months of golimumab treatment, there was a decrease in the prevalence of enthesitis (32.9% to 16.5%), nail (17.6% to 12.9%) and skin psoriasis (42.4% to 34.1%) in PsA patients; the frequency of extra articular manifestations tended to decrease also in axSpA patients.
Preliminary results of the GO-BEYOND-Italy study showed a good short-term effectiveness of golimumab in RA, PsA and axSpA after TNFi failure.
Salvatore D'Angelo Speakers bureau: AbbVie, BMS, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Consultant of: AbbVie, BMS, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB, Enrico Tirri Speakers bureau: AbbVie, Eli Lilly, Novartis, Pfizer, Angela Maria Giardino Employee of: MSD Italia, Marco Matucci-Cerinic Speakers bureau: BMS, Pfizer, Actelion, Consultant of: Eli-Lilly, Celgene, Chemomab, CSL Behring, Grant/research support from: BMS, Pfizer, Celgene, CSL Behring, Lorenzo Dagna Consultant of: Abbvie, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Novartis, Pfizer, Roche, Sanofi-Genzyme, and SOBI, Leonardo Santo: None declared., francesco ciccia: None declared., Bruno Frediani: None declared., Marcello Govoni: None declared., Francesca Bobbio Pallavicini: None declared., Rosa Daniela Grembiale: None declared., Andrea Delle Sedie: None declared., Stefania Cercone Employee of: MSD Italia, RITA MULE': None declared., Francesco Paolo Cantatore Speakers bureau: Pfizer, Sanofi Genzyme and Roche, Consultant of: Pfizer, Sanofi Genzyme and Roche outside this work., Rosario Foti: None declared., Elisa Gremese: None declared., Roberto Perricone: None declared., Fausto Salaffi: None declared., Ombretta Viapiana Speakers bureau: Novartis, UCB, Abbvie, MSD, Fresenius kabi, Gilead, Biogen, Consultant of: Novartis, Abbvie, Fresenius kabi, Gilead, Biogen, Alberto Cauli Speakers bureau: Abbvie, Alfa-Sigma, BMS, Celgene, Galapagos, Glaxo, MSD, Novartis, Janssen, Pfizer, Sanofi, UCB, Consultant of: Abbvie, Alfa-Sigma, BMS, Celgene, Galapagos, Glaxo, MSD, Novartis, Janssen, Pfizer, Sanofi, UCB, Rorberto Giacomelli: None declared., Luisa Arcarese: None declared., Giuliana Guggino Speakers bureau: Novartis, Celgene, Abbvie, Sandoz, Eli Lilly, Pfizer, Jansen, ROMUALDO RUSSO: None declared., Domenico Capocotta: None declared., Francesca Nacci: None declared., Maria Grazia Anelli: None declared., valentina picerno: None declared., Florenzo Iannone Speakers bureau: Pfizer, AbbVie, Janssen, Celgene, Novartis, MSD, BMS, UCB, Roche, Consultant of: Pfizer, AbbVie, Janssen, Celgene, Novartis, MSD, BMS, UCB, Roche outside this work.
Table 1Effectiveness of golimumab at 3 months in the GO-BEYOND-Italy studyRheumatoid arthritis (n=38)Psoriatic arthritis (n=91)Axial spondyloarthritis (n=64)DAS28-CRP, mean (SD)n=27DAS28-CRP, mean (SD)n=47ASDAS-CRP, mean (SD)n=44V0 / V14.05 (0.8) / 3.10* (1.0)V0 / V13.66 (1.0) / 2.79* (1.2)V0 / V12.86 (1.0) / 2.33* (1.0)V1: DAS28-CRP disease activity, n (%)n=27V1: EULAR response, n (%)n=33V1: ASDAS-CRP disease activity, n (%)n=46Remission8 (29.6)Good16 (48.5)Inactive disease7 (15.2)Low disease activity6 (22.2)Moderate10 (30.3)Low disease activity12 (26.1)Moderate disease activity13 (48.1)No response7 (21.2)High disease activity22 (47.8)Very high disease activity5 (10.9)V1: EULAR response, n (%)n=23V1: MDA, n (%)n=75Good7 (30.4)Yes21 (28.0)BASDAI, mean (SD)n=50Moderate8 (34.8)V0 / V15.99 (2.1) / 4.92 (2.3)*No response8 (34.8)V1: BASDAI50, n (%)7 (14.0)ASAS-HI, mean (SD)n=48V0 / V110.67 (3.8) / 9.68 (4.6)^*p value for the difference from V0 <0.01. ^ p for the difference from V0=0.032Abbreviations: ASDAS: Ankylosing Spondylitis Disease Activity Score; ASAS-HI: Assessment of SpondyloArthritis international society Health Index; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; CRP: C-reactive protein; DAS: disease activity score; EULAR: European League Against Rheumatism; MDA: Minimal Disease Activity; SD: standard deviation; V0: baseline; V1: 3 months evaluation.
Journal Article
Intravenous immunoglobulins improve the function and ameliorate joint involvement in systemic sclerosis: a pilot study
2007
Background: In systemic sclerosis (SSc), joint involvement may reduce the functional capacity of the hands. Intravenous immunoglobulins have previously been shown to benefit patients with SSc. Aim: To verify the efficacy of intravenous immunoglobulins on joint involvement and function in SSc. Patients and methods: 7 women with SSc, 5 with limited and 2 with diffuse SSc, with a severe and refractory joint involvement were enrolled in the study. Methotrexate and cyclophosphamide pulse therapy did not ameliorate joint symptoms. Hence, intravenous immunoglobulins therapy was prescribed at a dosage of 2 g/kg body weight during 4 days/month for six consecutive courses. The presence of joint tenderness and swelling, and articular deformities (due to primary joint involvement and not due to skin and subcutaneous changes) were evaluated. Before and after 6 months of treatment, patients were subjected to (1) Ritchie Index (RI) evaluation of joint involvement; (2) Dreiser Algo-Functional Index (IAFD) evaluation of hand joint function; (3) pain visual analogue scale (VAS) to measure joint pain; (4) Health Assessment Questionnaire (HAQ) to evaluate the limitations in everyday living and physical disability; and (5) modified Rodnan Skin Score for skin involvement. Results: After 6 months of intravenous immunoglobulins therapy, joint pain and tenderness, measured with the VAS, decreased significantly (p<0.03), and hand function (IAFD) improved significantly (p<0.02), together with the quality of life (HAQ; p<0.03). All patients significantly improved, except for one. The skin score after 6 months of intravenous immunoglobulins therapy was significantly reduced (p<0.003). Conclusion: This pilot study suggests that intravenous immunoglobulins may reduce joint pain and tenderness, with a significant recovery of joint function in patients with SSc with severe and refractory joint involvement. The cost of intravenous immunoglobulins might limit their use only to patients who failed disease-modifying antirheumatic drugs.
Journal Article
SAT0582 Incidence of Malignancies in Patients with Inflammatory Rheumatic Diseases and Biological Drugs: Experience from One Center in Italy
2016
BackgroundOver the past decade, it has been frequently suggested that the risk of cancer may be increased in patients with inflammatory rheumatic diseases treated with biologics. These drug have been considered as reducing immune surveillance. However, data from registries from different continents reported that treatment with TNF inhibitors did not increase the risk of malignancies, except for skin cancer (1).ObjectivesTo evaluate the incidence of malignancies in a cohort of our patients with inflammatory rheumatic diseases treated with biological drugs.MethodsThe charts of 1468 patients with Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis treated with Adalimumab, Etanercept, Infliximab, Certolizumab, Golimumab, Tocilizumab and Abatacept followed up from 2005 to 2015 at the Department of Rheumatology, University of Florence, were reviewed. Patients who developed a cancer (excluding basal cell skin cancer) during biological therapy were identified. The incidence of malignancies in our patients was compared to the incidence of cancer in the general population in the same period, same geographic area and with same age.ResultsOut of 1468 patients, 828 (56,4%) were affected by Rheumatoid Arthritis, 290 (19.7%) by Ankylosing Spondylitis and 350 (23.9%) by Psoriatic Arthritis. Twenty-five out of 1468 patients (1.7%) (mean age 65±9 years), developed cancer: in details, we found 5 (20%) lung cancer, 5 (20%) melanoma, 2 (8%) breast cancer, 1 (4%) liposarcoma, 1 (4%) tongue cancer, 1 (4%) colo-rectal cancer, 1 (4%) liver cancer, 1 (4%) squamous cell skin cancer, 1 (4%) intestinal lymphoma, 1 (4%) myeloid leukemia, 1 (4%) endometrial cancer, 1 (4%) cervical intraepithelial neoplasia (CIN III), 1 (4%) gastric cancer, 1 (4%) bladder cancer, 1 (4%) laryngeal carcinoma and 1 (4%) follicular NHL of parotid gland. Incidence among patients resulted as follows: 2,05% Rheumatoid Arthritis, 1,37% Ankylosing Spondylitis and 1,14% Psoriatic Arthritis. The percentage of cancer in patients was respectively: Etanercept 2,31%, Adalimumab 1,46%, Infliximab 1,18%, Golimumab 1%, Abatacept 1%, Tocilizumab 3,92% and Certolizumab 2,43%. From 2005 to 2010, the incidence of malignancies (excluding basal cell skin cancer), in general population between the age of 60 and 70 years in the Florence area was 0.39%.ConclusionsOur data suggest that in patients with inflammatory rheumatic diseases treated with biological drugs, cancer is increased of 289% compared to the general population. In these patients, the risk of malignancy still remains to be verified in larger cohorts in our area with a long-term controlled registry.ReferencesCodreanu C, Damjanov N. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries. Biologics. 2015 Jan 27;9:1–6. doi:10.2147/BTT.S68949. eCollection 2015. Review.Disclosure of InterestNone declared
Journal Article
Systemic lupus erythematosus in the young: the importance of a transition clinic
2007
The objective of this report is to focus on the problems of patients with childhood onset systemic lupus erythematosus (SLE) at the age of transition to an adult care Unit. SLE is a multisystem disease characterised by diffuse internal organ involvement and by the presence of antinuclear and anti DNA antibodies. Central nervous system and renal damage are the main complications especially in children. Transition in health-care is a multifaceted, active process that attends to the medical, psychosocial and educational-vocational needs of adolescents when they move from child to adult-oriented lifestyles and systems. Lack of institutional support and difficulty in communicating and in identifying adult specialists are the major concerns in a transition care Unit. Psychosocial matters can make this change dramatic and hard for young people and their families. Patients with juvenile-onset SLE require specialised and multidisciplinary care when entering a transition clinic; physicians need to focus on preventing long-term complications of SLE, including atherosclerosis, obesity, osteoporosis and their treatment. We report on our experience in a cohort of patients with juvenile SLE cared for at our transition clinic over last six years.
Journal Article