Combined 13-valent pneumococcal conjugate and 23-valent pneumococcal polysaccharide vaccine regimens for adults with systemic lupus erythematosus: Does the sequence of pneumococcal vaccination affect immunogenicity responses? A single-center cohort study in Brazil.

OBJECTIVE: A combination of 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) is currently recommended for adults with systemic lupus erythematosus (SLE). However, data on the immunogenicity elicited by sequential pneumococcal vaccination in this patient population are scarce. In this study, we compared short-term antibody responses to both PCV13/PPSV23 (≥8-week interval) and PPSV23/PCV13 (≥12-month interval) vaccination strategies in pneumococcal vaccine-naive adults with SLE. METHODS: This longitudinal, open-label, quasi-randomized study was performed in a single-center cohort of adults (18 years or older) with SLE. In both vaccination groups, blood samples were collected immediately before administering the first dose of the pneumococcal vaccine (timepoint T0), 4-6 weeks after the priming dose (T1), and 4-6 weeks after the booster dose (T2). We focused on the 12 shared serotypes between PCV13 and PPSV23, and compared the following immunogenicity outcomes between the groups at T2: anti-pneumococcal antibody geometric mean concentration (ApAb GMC), fold increase in ApAb levels (FI-ApAb), overall seroprotection rate, and overall seroconversion rate. The protective level for each pneumococcal serotype was set at 1.3 µg/mL. We used the multi-analyte immunodetection method to determine serum levels of ApAbs. RESULTS: Thirty-four patients with SLE were screened between April 2019 and January 2020, and 16 of them (mean age: 39.4 years, 87.5% female, and 100% on immunosuppressants) had evaluable immunogenicity results at T2. The median time elapsed between the pneumococcal vaccinations was 56 days in the PCV13/PPSV23 group (n = 11 patients) and 16 months in the PPSV23/PCV13 group (n = 5 patients). Priming with PCV13 (PCV13/PPSV23 group), as opposed to PPSV23 (PPSV23/PCV13 group), yielded significantly better results regarding FI-ApAb, overall seroconversion rate, and overall seroprotection rate 4-6 weeks after each pneumococcal vaccination. A trend toward augmented ApAb GMC in the patients who received the PCV13/PPSV23 sequence was also observed. No relevant safety issues were identified with sequential pneumococcal vaccination. CONCLUSION: The PCV13-priming PPSV23-boost strategy in adults with SLE induced greater antibody responses for most immunogenicity outcomes than those elicited by the PPSV23/PCV13 strategy.

Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial.

BACKGROUND: Treatment adherence is a primary determinant of the success and effectiveness of healthcare. Lack of adherence can lead to treatment failure and death. Although studies have shown that pharmaceutical intervention can improve drug treatment for patients with chronic diseases, studies on pharmaceutical care are not only inconsistent, they are scarce and limited to developed countries, include few patients, and are not studied in randomized clinical trials. Systemic lupus erythematosus is an autoimmune disease with high hospitalization and case-fatality rates. The adherence rate is low (31.7 %) in this group of patients in Brazil, and drug treatment for the disease is complex. Our objective is to evaluate the effectiveness of pharmaceutical care in drug treatment adherence in patients with systemic lupus erythematosus treated at a rheumatology outpatient clinic in Rio de Janeiro, Brazil. METHODS: A randomized clinical trial (pragmatic trial) will be conducted. Adult participants (women) from a public hospital in Rio de Janeiro with a diagnosis of systemic lupus erythematosus will be followed for 12 months. A total of 120 patients will be randomized to two groups: intervention (Dader method for pharmaceutical care) and control (health/dietary counseling and risk reduction). The primary outcome will be drug treatment adherence evaluated by the eight-item Morisky Medication Adherence Scale. Secondary outcomes will be clinical improvement and quality of life. DISCUSSION: Patients with systemic lupus erythematosus present with low treatment adherence, thus justifying the mobilization of human resources to optimize their clinical management. Despite the proven effectiveness of pharmaceutical care for various diseases, there are still no studies evaluating its effectiveness in systemic lupus erythematosus. Our hypothesis is that the intervention will also be effective in this patient group. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02330250 .