0-10). Utilities were measured with the EuroQoL (EQ-5D utility ) (range 0-1). A time-integrated summary score defined the clinical effects (BASFI-AUC) and utilities (EQ-5D utility -AUC) over time. Both direct (health care and non-health care) and indirect costs were included. Resource utilisation and absence from paid work were registered weekly by the patients in a diary. All costs were calculated from a societal perspective. Results 111 patients completed the diary (group 1 n = 38; group 2 n = 36; control group n = 37). The between-group difference (95% CI) for the BASFI-AUC was 1.0 (0.4 to 1.6; p = 0.001) for group 1 versus controls, and 0.6 (0.1 to 1.1; p = 0.020) for group 2 versus controls. The between-group difference for the EQ-5D utility -AUC was 0.17 (0.09 to 0.25; p < 0.001) for group 1 versus controls, and 0.08 (0.00 to 0.15; p = 0.04) for group 2 versus controls. The mean total costs per patient (including costs for spa therapy) during the study period were ?3023 for group 1, ?3240 for group 2, and ?1754 for the control group. The incremental cost-effectiveness ratio was ? 1269 per unit effect gained in functional ability for group 1, and ?2477 for group 2. The costs per QALY gained were ?7465 for group 1 and ?18575 for group 2. Conclusion Combined spa-exercise therapy is more effective and shows favourable cost-effectiveness and cost-utility ratios compared to weekly group physical therapy alone in patients with ankylosing spondylitis.
Background The anti-TNF therapy has been a great progress in RA patients treatment. However, a proportion of patients develop primary inefficacy or loss of response, resulting in switching or treatment discontinuation. Recent studies correlate the antidrug antibodies (ADA) development with loss of efficacy. Objectives To asses in RA patients treated with infliximab (Ifx) or adalimumab (Ada) whether ADA development influences on the clinical efficacy and treatment duration. Methods We studied ambispectively 174 RA patients from La Paz University Hospital who received Ifx or Ada between years 2000-2012, both in combination with synthetic DMARDs or in monotherapy. The assessment of disease activity was performed by Disease Activity Score 28 (DAS28) and clinical improvement by delta-DAS28. Measurements were performed at baseline, 1, 2 and ≥ 3 years under the biological therapy (BT). ADA and drug levels were measured by ELISA. Statistical analysis was performed using SPSS 11.0. Results Of the 174 patients, 140 (80.5%) were women. The mean age was 57 ± 13.2 years and the disease duration was 14.7 ± 8.0 years. 128 patients (73.6%) were RF positive. The mean duration on BT was 5.0 ± 3.0 years. One hundred fifty patients (86.2%) received methotrexate, 98 other DMARDs (56.3%) and 11 (6.3%) were in monotherapy. The mean DAS28 at baseline was 5.28 ± 1.26 and there was no significant differences between DAS28 at baseline in patients with or without ADA ( 5,28±1,47 ADA+ vs 5,25±1,19 ADA-, p=0,918). Along the study, 62 patients (35.6%) developed ADA (47/105 patients (44.8%) to Ifx and 15/69 patients (21.7%) to Ada, p = 0.002). Ninety six (55.2%) patients dropped out the BT and this was more frequent in ADA positive patients [49/62 (79.0%) ADA+ vs. 47/112 (41.9%) ADA-, p <0.00001]. Most patients who discontinued by inefficacy had ADA [25/39 (64.1%) ADA+ vs 14/39 (35.9%) ADA-, p = 0.039]. Patients with ADA were more active in all studied point (at 1st year: 4.69 ± 1.15 ADA+ vs 3.43 ± 1.22 ADA-, p<0.0001; at 2nd year: 3.96 ± 1.40 ADA+ vs 3.08 ± 1.09 ADA-, p= 0.015; at 3rd year: 4.34 ± 1.26 ADA+ vs 3.21 ± 1.56 ADA-, p = 0.001). The clinical improvement was lower in ADA positive patients along this work (at 1st year: 0.94 ± 1.06 ADA+ vs 1.63 ± 1.32 ADA-, p = 0.045; at 2nd year: 0.72 ± 1,05 ADA+ vs. 1.83 ± 1.59 ADA-, p =0.021; at 3rd year: 0.44 ± 1.26 ADA+ vs 2,02 ± 1.87 ADA-, p<0.0001). Conclusions The ADA development in RA patients treated with Ifx or Ada is correlated with a clinical inefficacy and with the therapy survival, resulting in an earlier therapy discontinuation. Disclosure of Interest None Declared
Background/objectives Factors associated with chronic heart failure (CHF) in patients with systemic lupus erythematosus (SLE) have received little attention. Recent data on the use of hydroxychloroquine in the treatment of SARS-CoV-2 infection have cast doubt on its cardiac safety. The factors associated with CHF, including therapy with antimalarials, were analyzed in a large multicenter SLE cohort. Methods Cross-sectional study including all patients with SLE (ACR-1997 criteria) included in the Spanish Society of Rheumatology Lupus Register (RELESSER), based on historically gathered data. Patients with CHF prior to diagnosis of SLE were excluded. A multivariable analysis exploring factors associated with CHF was conducted. Results The study population comprised 117 patients with SLE (ACR-97 criteria) and CHF and 3,506 SLE controls. Ninety percent were women. Patients with CHF were older and presented greater SLE severity, organ damage, and mortality than those without CHF. The multivariable model revealed the factors associated with CHF to be ischemic heart disease (7.96 [4.01-15.48], p<0.0001), cardiac arrhythmia (7.38 [4.00-13.42], p<0.0001), pulmonary hypertension (3.71 [1.84-7.25], p<0.0002), valvulopathy (6.33 [3.41-11.62], p<0.0001), non-cardiovascular damage (1.29 [1.16-1.44], p<0.000) and calcium/vitamin D treatment (5.29 [2.07-16.86], p=0.0015). Female sex (0.46 [0.25-0.88], p=0.0147) and antimalarials (0.28 [0.17-0.45], p<0.000) proved to be protective factors. Conclusions Patients with SLE and CHF experience more severe SLE. Treatment with antimalarials appears to confer a cardioprotective effect.
BackgroundGender has been lately suggested as influential in the response to treatment with biological drugs in spondyloarthritis, such as psoriatic arthritis (PsA). However, data about the association between gender and treatment response in axial PsA (axPsA) or peripheral PsA (pPsA) are scarce.ObjectivesTo analyze the association between gender and clinical response to biological therapy in patients with axPsA and pPsA.MethodsAn observational cohort study was conducted, prospectively collecting data from 108 patients treated with biological therapy (93% TNFi and 7% IL-17i) from 2002-2018. Patients were divided into two groups according to their clinical predominant manifestation: axPsA or pPsA. Disease activity indexes (ASDAS and BASDAI for axPsA and DAPSA and DAS28 for PsA) were collected before starting drug and 6 months later (baseline and 6m visit, respectively). Low disease activity (LDA) was defined as aSDAS <2.1 or BASDAI <4 (axPsA) and DAPSA ≤14 or DAS28 ≤ 3.2 (pPsA). Clinical improvement was defined as an improvement ≥ 1.1 points in aSDAS (dASDAS) or 50% in BASDAI (BASDAI50) for axPsA, and an improvement of 50% in DAPSA (DAPSA50) or dDAS28 ≥ 1.2. First, the frequency of male- and female-patients achieving LDA and clinical improvement at 6m were compared using Fisher test, separately for axPsA and pPsA. Second, the association between gender and each of the clinical outcomes was analyzed using logistic regression models adjusted for confounders (age, disease duration, previous biologics, smoking habit, body mass index (BMI), baseline DMARDs and baseline disease activity (ASDAS or BASDAI for axPsA and DAPSA or DAS28 for pPsA).ResultsOut of 108 included patients, 55 (51%) had predominant axPsA and 54 (49%) pPsA. In the group of axPsA, 35 (64%) were males, 33 (60%) were non-smokers, 33 (60%) had a BMI ≥25, with mean (SD) baseline disease activity of aSDAS: 3.3 (1.0) and BASDAI: 5.4 (2.0). The frequency of patients achieving clinical response was higher in males than females (LDA: 74% vs 37%; p=0.02, respectively) (Table 1). After adjusting for confounders, male gender was significantly associated with higher probability of achieving LDA (ASDAS OR=4.4; p=0.03 and BASDAI OR=6.0; p=0.01), and clinical improvement (dASDAS: OR=4.8; p=0.04 and BASDAI50: OR=5.19; p=0.03). In the group of pPsA, 20 (37%) were males, 37 (68%) were non-smokers, 34 (63%) had a BMI ≥25, with mean (SD) baseline disease activity indexes of DAPSA: 26 (14.9) and DAS 28: 4.8 (1.2). The frequency of patients achieving LDA was higher in males than females (74% vs 39%; p=0.02, respectively). After adjusting for cofounders, male gender was independently associated with higher probability of achieving LDA by DAPSA (OR=4.0; p=0.03) and DAS28 (OR= 2.1; p=0.3). Finally, an association between male gender and clinical improvement was also observed but this was statistically significant only when using dDAS28 as the outcome: OR=2.9; p=0.1 for DAPSA50 and OR=5.8; p=0.02 dDAS28.ConclusionMale gender is associated with a higher rate of response to biolog...
Background Undifferentiated arthritis could be an early stage or forme fruste of a definite rheumatic disease. Objectives The purpose of this poster is to describe the evolution of 40 patients (>16 years) in our hospital, with seronegative mono-oligoarthritis, HLA B27 negative, without axial involvement, that at the onset of the disease did not meet the criteria to be included in any other defined arthropathy. Methods Forty patients (21 females and 19 males) with seronegative undifferentiated oligoarthritis, without axial involvement, that could not be typified as rheumatic disease of the rheumatoid, psoriatic, enteropathic, gouty, or reactive type, were studied retrospectively. In all patients the presence of crystals in their synovial fluid was discared as well as skin or eye symptoms, infectious diseases (Salmonella, Shigella, Yersinia, Ureaplasma and mycobacteria) or associated connective-tissue disease. Results The mean age at the onset of oligoarthritis was 42.1 years (44.9 for males and 36.3 for females). The average duration of follow-up was 11.1 years (range 24-1). Eight (28%) of the 40 patients had just one joint affected while the remaining patients presented with 4 or less involved joints. In 8 of our cases (20%) the disease resolved spontaneously. In 12 patients (30%), a definitive diagnosis was made after an average of 4.1 years (range 13-1) from the onset to the final diagnosis. Among these 12 patients, 5 were diagnosed as gout, 2 as arthropathy associated with inflammatory bowel disease, 2 as psoriatic arthritis, 2 as rheumatoid arthritis and one case of SAPHO associated arthropathy. In the remaining patients the disease followed a chronic course and no improvement was detected. Only 16 of the 40 patients received specific antirheumatic drug therapy: 10 of the 20 cases in which the disease took a chronic course and for which no diagnosis was reached. Conclusion We would like to stress that no rheumatologist would deny the difficulty implied in diagnosing and managing patients with undifferentiated mono-oligoarthritis that do not fit into any typified rheumatic disease. Nevertheless, although 50% of our patients have not yet been definitively diagnosed after a 6.5 year average follow-up, a final diagnosis has been reached for 30% of the total number in a 4.1-year period on the average.
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