Patients with rheumatic diseases on biological therapy have a greater risk of infections. Vaccination recommendations have been established, but, the effectiveness of vaccines in these patients is not well known, and it seems to depend on the different types of treatment used.
Objectives
To evaluate the response of vaccines against A and B Influenza, hepatitis B and pneumococcus in patients on biological treatment.
Methods
Patients with inflammatory arthopathies, psoriasis (Pso), inflammatory bowel disease (IBD) or connective tissue diseases (CTD) that were on or were going to initiate biological therapy, were included. A and B influenza antibodies (Ab) were measured by ELISA. A good response was achieved when base-line titer was increased by four. Hepatitis B surface antibody (Hep B sAb) was measured by ELISA and considered positive with a final titer >10m IU/ml. Protection against pneumococcus serotypes 1, 3, 7F, 14, 19A and 19F was measured by an opsonophagocytosis killing assay (OPKA). Opsonization titers (OT) were defined as the serum dilution that kills 50% of bacteria.
Results
280 subjects were included, 167 women (59.6%), with a average age of 49.5±13.2 years. 35% were Rheumatoid Arthritis patients, 33.9% had spondiloarthropathies, 16.8% Psoriatic Arthritis, 5.4% Pso, 2.9% IBD and 6% other diagnostics. 84% of patients were on anti-tumor necrosis factor therapies, 8.9% on Rituximab, 5% on tocilizumab, 1.4% on abatacept and 1.4% received other biologics. 45.4% of subjects were also on DMARDs and 18% on corticosteroids. A good response to influenza A vaccine was achieved in only 3.7% of patients for A influenza and 3.2% for type B, even though the majority of patients showed detectable titers of Ab in sera. 75% of patients had been vaccinated against hepatitis B before beginning the biological therapy. More than 90% of patients vaccinated against hepatitis B during the study achieved a good response. 40% of subjects showed OT against 3 or more pneumococcal serotypes.
Conclusions
The response from patients on biological therapy to the influenza vaccine is lower than expected. Comparative studies between these patients and those without biological treatment and healthy people are needed. There is a considerable amount of patients that have not received hepatitis B vaccine before the beginning of the biological treatment, although the response to this vaccine is good. Pneumococcal vaccine is successful in a considerable proportion of subjects. It is worth insisting on its administration.
Abstract Objective To evaluate the sensitivity to change of power Doppler ultrasound (PDUS) assessment of joint inflammation and the predictive value of PDUS parameters in disease activity and radiologic outcome in patients with early rheumatoid arthritis (RA). Methods Forty‐two patients with early RA who started therapy with disease‐modifying antirheumatic drugs underwent blinded sequential clinical, laboratory, and ultrasound assessment at baseline, 3 months, 6 months, and 1 year and radiographic assessment at baseline and 1 year. For each patient, 28‐joint Disease Activity Score (DAS28) was recorded at each visit. The presence of synovitis was investigated in 28 joints using gray‐scale ultrasonography and intraarticular power Doppler signal. Active synovitis was defined as intraarticular synovitis detected with power Doppler signal. The ultrasound joint count for active synovitis and an overall joint index for power Doppler signal were calculated. Sensitivity to change of PDUS variables was assessed by estimating the smallest detectable difference (SDD) from the intraobserver variability. Results The SDD for ultrasound joint count for active synovitis and ultrasound joint index for power Doppler signal was lower than mean changes from baseline to 3 months, 6 months, and 1 year. Time‐integrated values of PDUS parameters demonstrated a highly significant correlation with DAS28 after 1 year (r = 0.63, P < 0.001) and a stronger correlation with radiographic progression (r = 0.59–0.66, P < 0.001) than clinical and laboratory parameters (r < 0.5). Conclusion PDUS is a sensitive and reliable method for longitudinal assessment of inflammatory activity in early RA. PDUS findings may have a predictive value in disease activity and radiographic outcome.
Patients with incomplete Systemic Lupus Erythematosus may represent a group of patients who will later develop SLE or they may form a subset of SLE patients with mild disease.
Objectives
To study the differences in clinical manifestations, damage, co-morbidity and disease severity between patients with defined SLE (dSLE) and those with incomplete SLE (iSLE), included in RELESSER registry.
Methods
All patients included in the transversal phase of RELESSER were studied. The registry includes demographic data, clinical manifestations, information about activity, damage, severity, comorbidity, treatments and mortality, collecting 359 variables per patient, with highly standardized definitions. SELENA-SLEDAI (S-SLEDAI) and SLICC/ACR/DI (SDI) scores and Katz index (IK) were calculated. To compare both groups an analysis based on the estimation of simple and adjusted odds ratios (OR) by means of logistic regression, with 95% confidence intervals (95%CI) was done.
Results
4,024 SLE patients were included (91% females; mean age at diagnosis:35.4 years; disease duration: median 11.0 years). 3,679 (91.4%) were dSLE and 345 (8.6%) iSLE. dSLE were younger than iSLE at diagnosis (34.6 vs 42.9 years) (OR:0.92; CI95%: 0.90-0.96; p<0.001), with a longer disease duration (12 vs 8 years) (OR:1.05; CI95%: 1.03-1.07; p<0.001). As it was supposed, most clinical manifestations were more frequent in dSLE patients. Every one of the ACR criteria was associated with dSLE condition and this association was extremely high in the cases of malar rash (OR:9.14; CI95%:6.20-13.46; p<0.001), oral ulcers (OR:9.37; CI95%:6.08-14.45; p<0.001) and renal disorder (OR:9.12; CI95%:5.18-16.07; p<0.001). The analysis adjusted by gender, age at onset and disease duration showed higher S-SLEDAI (OR:1.14;CI95%:1.08-1.20;p<0.001), SDI (OR:1.29; CI95%:1.15-1.44; p<0.001), KI (OR:2.10; CI95%:1.83-2.42; p<0.001), number of hospitalizations due to SLE activity (OR:2.79; CI95%:2.15-3.63; p<0.001) and mortality (OR:2.25; CI95%:1.24-4.48; p=0.008) in dSLE patients than in iSLE ones. Higher number of dSLE received glucocorticoids (OR:3.22; CI95%:2.43-4.25; p<0.001), cyclophosphamide (OR:3.47; CI95%:2.12-5.67; p<0.001), mycophenolate mofetil (OR: 3.45; CI95%:1.91-6.25; p<0.001) and rituximab (OR:3.34; CI95%:1.36-8.23; p=0.009). Refractoriness were associated with the dSLE condition (OR:3.04; CI95%:1.98-4.68; p<0.001). Although there were differences in certain risk factors between both groups, it was not the case in cardiovascular events.
Conclusions
These results, obtained from the largest iSLE patients cohort reported up to now, support the hypothesis that iSLE behaves as a relative stable and mild disease, with lower activity, severity and refractoriness than dSLE.
Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by multiple organ involvement and pronounced racial and ethnic heterogeneity. The aims of the present work were (1) to describe the cumulative clinical characteristics of those patients included in the Spanish Rheumatology Society SLE Registry (RELESSER), focusing on the differences between patients who fulfilled the 1997 ACR-SLE criteria versus those with less than 4 criteria (hereafter designated as incomplete SLE (iSLE)) and (2) to compare SLE patient characteristics with those documented in other multicentric SLE registries. RELESSER is a multicenter hospital-based registry, with a collection of data from a large, representative sample of adult patients with SLE (1997 ACR criteria) seen at Spanish rheumatology departments. The registry includes demographic data, comprehensive descriptions of clinical manifestations, as well as information about disease activity and severity, cumulative damage, comorbidities, treatments and mortality, using variables with highly standardized definitions. A total of 4.024 SLE patients (91% with ≥4 ACR criteria) were included. Ninety percent were women with a mean age at diagnosis of 35.4 years and a median duration of disease of 11.0 years. As expected, most SLE manifestations were more frequent in SLE patients than in iSLE ones and every one of the ACR criteria was also associated with SLE condition; this was particularly true of malar rash, oral ulcers and renal disorder. The analysis—adjusted by gender, age at diagnosis, and disease duration—revealed that higher disease activity, damage and SLE severity index are associated with SLE [OR: 1.14; 95% CI: 1.08–1.20 (P < 0.001); 1.29; 95% CI: 1.15–1.44 (P < 0.001); and 2.10; 95% CI: 1.83–2.42 (P < 0.001), respectively]. These results support the hypothesis that iSLE behaves as a relative stable and mild disease. SLE patients from the RELESSER register do not appear to differ substantially from other Caucasian populations and although activity [median SELENA-SLEDA: 2 (IQ: 0–4)], damage [median SLICC/ACR/DI: 1 (IQ: 0–2)], and severity [median KATZ index: 2 (IQ: 1–3)] scores were low, 1 of every 4 deaths was due to SLE activity. RELESSER represents the largest European SLE registry established to date, providing comprehensive, reliable and updated information on SLE in the southern European population.
Antiperinuclear factor (APF) is an autoantibody detected in >50% of patients with rheumatoid arthritis (RA); it shows a specificity of roughly 90%. We investigated the possible role of APF as a prognostic marker in RA.A series of 103 patients with RA who fulfilled the 1987 American College of Rheumatology criteria (88 women and 15 men; mean age 55.5 yrs, mean disease duration 9 yrs) were prospectively followed. Sixteen variables were assessed in each patient at inclusion and over a 3 year period. APF was determined by indirect immunofluorescence assay using human buccal mucosal cells as substrate. APF assays were done at entry and at the end of followup without knowledge of the clinical status of the patients. Mann-Whitney U, chi-squared tests, variance analysis, and kappa index were used for statistical analysis.Eighty of 103 patients completed followup. APF was detected in 40 of 80. At inclusion, APF correlated with the visual analog scale (VAS) of pain (p = 0.02). However, patients who showed APF positivity at entry had a less favorable course than APF negative individuals, as shown by a worse VAS of well being (p = 0.01), Ritchie index (p = 0.01), number of painful joints (p = 0.03), grip strength (p = 0.01), C-reactive protein (p = 0.04), and Health Assessment Questionnaire score (p = 0.03) at the end of the study. In addition, APF positive patients showed a worse radiological course (p = 0.03).Our results suggest APF is a possible marker of poor prognosis in RA.