Identification and characteristics of patients with potential difficult-to-treat Psoriatic Arthritis: exploratory analyses of the Greek PsA registry.

OBJECTIVE: To present the characteristics of patients with potential difficult-to-treat (D2T) psoriatic arthritis (PsA). METHODS: We used data from the Greek multicentre registry of PsA patients. D2T-PsA was defined as follows: patients with at least 6-months disease duration, who have failed to at least 1 csDMARD and at least 2 bDMARDs/tsDMARDs with a different mechanism of action and have either at least moderate disease activity (MODA) defined as DAPSA > 14, and/or are not at minimal disease activity (MDA). Demographic and clinical characteristics were compared between D2T and non-D2T PsA patients. In two sensitivity analyses, patients classified as D2T solely according to the MODA or MDA criterion were examined separately. RESULTS: Among 467 patients included, 77 (16.5%) were considered D2T and 390 non-D2T PsA. Compared with non-D2T, patients with D2T PsA presented more commonly with extensive psoriasis (p< 0.0001) and were more likely to have higher BMI (p= 0.023) and a history of inflammatory bowel disease (p= 0.026). In the MODA and MDA sensitivity analyses, 7.5% and 12.5% of patients were considered D2T, respectively. In both sensitivity analyses, extensive psoriasis was again identified as an independent variable for D2T PsA (p= 0.001 and p= 0.008, respectively). Moreover, female gender (p= 0.034) in the MODA analysis and axial disease (p= 0.040) in the MDA analysis were independent variables for D2T PsA. CONCLUSION: Despite the availability of therapies, D2T PsA is common in real-life cohorts of patients with PsA and extensive psoriasis. High BMI, female gender, axial-disease, and history of IBD were also associated with D2T PsA.

Omicron variant dominance and anti-SARS-CoV-2 vaccination are key determinants for a milder course of COVID-19 in patients with systemic autoimmune rheumatic diseases.

INTRODUCTION: This study aimed to determine whether the introduction of anti-SARS-CoV-2 vaccines and the dominance of the omicron variant had a significant impact on the outcome of COVID-19 in patients with systemic autoimmune rheumatic diseases (SAIRDs). METHODS: Using data entered to the Greek Rheumatology Society COVID-19 registry, we investigated the incidence of hospitalization and death due to COVID-19, during the successive periods of the pandemic according to the prevalent strain (wild-type, Alpha, Delta, Omicron) in vaccinated and unvaccinated patients. Variables independently associated with hospitalization and death were explored using multivariate regression analyses, while Kaplan-Meier curves were used to depict survival data. RESULTS: From August 2020 until June 30, 2022, 456 cases (70.2% females) of COVID-19 with a mean age (± SD) of 51.4 ± 14.0 years were reported. In unvaccinated patients, the proportions of hospitalization and death were 24.5% and 4%, compared to 12.5% and 0.8% in the vaccinated group (p < 0.001 for both comparisons). The rates of hospitalization for the wild-type, Alpha, Delta, and Omicron periods were 24.7%, 31.3%, 25.9%, and 8.1% respectively (p < 0.0001), while the case fatality rates were 2.7%, 4%, 7%, and 0%, respectively (p = 0.001). Using multivariable regression analysis, factors independently associated with hospitalization were infection by a non-Omicron variant, being non-vaccinated, exposure to rituximab, older age, and respiratory and cardiovascular disease. Independent predictors for death were contracting COVID-19 during the Alpha or Delta period, pulmonary disease, and older age, while being vaccinated was protective. CONCLUSIONS: In this 2-year analysis, the rates of hospitalization and death among patients with SAIRDs have declined significantly. Vaccination and the dominance of the Omicron variant appear to be the major determinants for this shift. Key points • During the late phase of the pandemic, the proportion of severe COVID-19 cases, defined as requiring hospitalization or resulting in death, in patients with systemic autoimmune rheumatic diseases has declined. • Anti-SARS-CoV-2 vaccination and the dominance of the Omicron strain are the key factors that have independently contributed to this shift.

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.

Disease Profile and Achievement of Therapeutic Goals in a Modern, Nationwide Cohort of 923 Patients with Psoriatic Arthritis.

Background: Psoriatic arthritis (PsA) is a heterogenous chronic inflammatory disease affecting skin, joints, entheses, and spine with various extra-musculoskeletal manifestations and comorbidities. The reported patient, disease and treatment characteristics in the modern therapeutic era are limited. Methods: In this cross-sectional, multi-centre, nationwide study, we recorded the demographic, clinical, and therapeutic characteristics as well as the comorbidities of patients with PsA seen for 1 year (1/1/2022-31/12/2022). Results: 923 patients (55% females) with a median (IQR) age of 57 (48-65) years and a mean disease duration of 9.5 years were enrolled. Family history of psoriasis and PsA was noted in 28.3% and 6.3%, respectively. Most patients had limited psoriasis (BSA<3: 83%) while enthesitis, dactylitis, nail and axial involvement reported in 48.3%, 33.2%, 43% and 25.9% of patients, respectively. Regarding comorbidities, approximately half of patients had dyslipidaemia (42%) or hypertension (45.4%), 36.8% were obese and 17% had diabetes while 22.7% had a depressive disorder. Overall, 60.1% received biologics and among them more patients treated with anti-IL-17 or -12/23 agents were on monotherapy (64.2%) compared to those on TNFi monotherapy (49.4%, p=0.0001). The median PsA activity as assessed by the DAPSA score was 6 (IQR: 2.3 - 13.1) with 46% of patients reaching minimal disease activity status (MDA). Conclusion: In this large, real life, modern cohort of patients with PsA with frequent comorbidities who were treated mainly with biologics, almost half achieved minimal disease activity. These results show the value of existing therapeutic approaches while at the same time highlight the existing unmet needs.

SLICC-Frailty Index is independently associated with impaired physical function, activities of daily living and quality of life measures.

OBJECTIVE: The SLICC Frailty Index (SLICC-FI) was developed to assess health deficits including disease activity, organ damage, comorbidities and functional status. We examined any relationship between SLICC-FI and objective physical function measures, activities of daily living performance and quality of life in SLE. METHODS: SLICC-FI was estimated using data from patient files and patient-reported questionnaires. Jamar Dynamometer, pinch gauge and Purdue pegboard test measured grip strength, pinch strength and dexterity, respectively. Activities of daily living performance was assessed by the Disabilities of Arm, Shoulder and Hand (DASH) questionnaire and HAQ. Quality of life was evaluated by LupusQol questionnaire. RESULTS: This cross-sectional study included 240 SLE patients (90% female, mean (s.d.) age: 47.63 (13.01), median (IQR) disease duration: 9 (4-16)). Mean (s.d.) SLICC-FI was 0.09 (0.06). Forty-three (17.9%) patients were classified as robust, 105 (43.8%) as relatively less fit, 77 (32.1%) as least fit and 15 (6.2%) as frail. In univariate analysis, SLICC-FI was significantly associated with DASH and HAQ with an inverse association with grip strength, pinch strength and all purdue scores (all P < 0.001). A negative correlation was found between SLICC-FI score and all LupusQoL domain scores (all P < 0.001). All associations remained statistically significant in multivariate regression analysis, after adjustment for age, disease duration, SLEDAI-2K, SLICC, immunosuppressives, corticosteroids and Charlson score. CONCLUSION: SLICC-FI is independently associated with poor physical function and activities of daily living performance and impaired quality of life and may help to identify patients in need of additional interventions beyond routine care.

Better outcomes of COVID-19 in vaccinated compared to unvaccinated patients with systemic rheumatic diseases.

OBJECTIVE: Τo report outcomes of breakthrough COVID-19 in comparison with COVID-19 in unvaccinated patients with systemic rheumatic diseases (SRDs). METHODS: Patients with SRD with COVID-19 (vaccinated and unvaccinated) were included by their rheumatologists in a registry operated by the Greek Rheumatology Society in a voluntarily basis. Type, date and doses of SARS-CoV-2 vaccines were recorded, and demographics, type of SRD, concurrent treatment, comorbidities and COVID-19 outcomes (hospitalisation, need for oxygen supplementation and death) were compared between vaccinated and unvaccinated patients. RESULTS: Between 1 March 2020 and 31 August 2021, 195 patients with SRD with COVID-19 were included; 147 unvaccinated and 48 vaccinated with at least one dose of a SARS-CoV-2 vaccine (Pfizer n=38 or AstraZeneca n=10). Among vaccinated patients, 29 developed breakthrough COVID-19 >14 days after the second vaccine dose (fully vaccinated), while 19 between the first and <14 days after the second vaccine dose (partially vaccinated). Despite no differences in demographics, SRD type, treatment or comorbidities between unvaccinated and vaccinated patients, hospitalisation and mortality rates were higher in unvaccinated (29.3% and 4.1%, respectively) compared with partially vaccinated (21% and 0%) or fully vaccinated (10.3% and 0%) patients. CONCLUSIONS: Vaccinated patients with SRD with breakthrough COVID-19 have better outcomes compared with unvaccinated counterparts with similar disease/treatment characteristics.

Impaired hand function and performance in activities of daily living in systemic lupus erythematosus, even in patients achieving lupus low disease activity state (LLDAS).

OBJECTIVE: The aim was to examine hand function and performance in activities of daily living (ADL) in patients with SLE vs healthy controls, and any associations with demographic and disease-related characteristics. METHODS: Hand function (grip strength, pinch strength and dexterity) and ADL performance were evaluated in 240 patients with SLE and 122 age- and biological sex-matched healthy controls. Grip strength, pinch strength and dexterity were measured by Jamar dynamometer, pinch gauge and Purdue pegboard test, respectively. Self-reported ADL performance was assessed by disabilities of the arm, shoulder and hand (DASH) and HAQ. Regression analysis was performed to assess the determinants of hand dysfunction. RESULTS: All hand function and ADL performance variables were significantly impaired in the entire SLE cohort and the subgroup of patients achieving lupus low disease activity state (LLDAS; n = 157) compared with healthy subjects (P < 0.05). Joint pain, often underestimated in SLE, was the major determinant of hand function and ADL performance in multiple regression models. In addition, age was correlated with grip strength and Purdue scores, gender with grip strength, arthritis with DASH and HAQ, and use of immunosuppressives with DASH, HAQ and grip strength. Likewise, in patients in LLDAS, painful joints were correlated with DASH and HAQ, age with grip strength and Purdue (P < 0.001), gender with grip strength, and immunosuppressives with HAQ and grip strength. CONCLUSION: Hand function and performance of daily activities are significantly impaired in SLE, even in patients who achieve LLDAS, suggesting the need for their evaluation and management in clinical practice.

The impact of upper limb exercise on function, daily activities and quality of life in systemic lupus erythematosus: a pilot randomised controlled trial.

OBJECTIVE: To assess the effect of upper limb exercise on hand function, daily activities performance and quality of life of patients with systemic lupus erythematosus (SLE). METHODS: We performed a pilot randomised, 24-week follow-up, unmasked controlled trial. Inclusion criteria were upper limb arthralgias, a Disabilities of Arm, Shoulder and Hand (DASH) questionnaire score >10 and a stable treatment over the past 3 months. Patients were randomly allocated in the routine care (control) or exercise group that received an individually tailored 30-min daily upper-limb exercise programme by a hand therapist for 12 weeks. We evaluated at 0, 6, 12 and 24 weeks the performance of daily activities for both groups with DASH questionnaire and Health Assessment Questionnaire (HAQ), the grip and pinch strength with Jamar dynamometer and pinch gauge tool, respectively, the dexterity with Purdue pegboard test, the quality of life with Lupus Quality of Life (LupusQoL) Questionnaire and the pain level by Visual Analogue Scale (VAS) score. RESULTS: From 293 consecutive SLE patients, data from 32 patients allocated to the exercise group and 30 to the control group were analysed. There was a significant difference between the two groups in percentage changes of DASH, HAQ, grip strength, pinch strength, LupusQoL-physical health and fatigue, and VAS scores from baseline to 6, 12 and 24 weeks, and from baseline to 12 weeks for dexterity test (p<0.001). No interaction was observed between exercise and disease activity or medication use at baseline and during the observation period. CONCLUSION: Upper-limb exercise significantly improves hand function, pain, daily activity performance and quality of life in SLE. TRIAL REGISTRATION NUMBER: NCT03802578.