Switch therapy da associação de ampicilina e sulbactam em complexo hospitalar do sul do Brasil

Objetivo: Identificar a frequência de intervenções farmacêuticas realizadas e aceitas pelas equipes médicas e a redução de custos gerada pelo switch therapy da associação de ampicilina e sulbactam para a associação de amoxicilina e clavulanato de potássio em pacientes adultos de um complexo hospitalar. Métodos: Estudo observacional do tipo transversal, baseado na avaliação de pacientes adultos em uso endovenoso da associação de ampicilina e sulbactam por mais de três dias, no período de abril a junho de 2021. A amostragem foi feita por conveniência. As intervenções sugerindo a alteração para o comprimido da associação de amoxicilina e clavulanato de potássio foram realizadas por meio de alerta padrão e evolução no prontuário eletrônico dos pacientes elegíveis. O aceite foi verificado pelo acompanhamento de nova prescrição. Caso não fosse aceita, uma nova intervenção era realizada em 48 horas. A redução de custos foi calculada com base no custo médio de medicamentos e materiais médicos, disponível no sistema informatizado da instituição. Os dados coletados foram analisados por meio de estatística descritiva. Resultados: Um total de 322 pacientes foram avaliados, dos quais 174 (54,0%) foram considerados elegíveis para a switch therapy. Foram realizadas 226 intervenções farmacêuticas, das quais 14 (6,2%) foram aceitas pelas equipes médicas, gerando uma economia de US$912,56. Conclusões: As intervenções farmacéuticas recomendando a switch therapy da associação de ampicilina e sulbactam tiveram baixa adesão das equipes médicas, mas, apesar disso, apresentaram um potencial significativo de redução de custos. Para obtenção de melhores resultados, faz-se necessário promover a educação do corpo clínico e aprimorar a comunicação entre farmacêuticos e médicos.

Real-World Experience with Brolucizumab in Wet Age-Related Macular Degeneration: The REBA Study

The aim of the present study was to determine the efficacy and safety of intravitreal brolucizumab therapy for neovascular age-related macular degeneration (AMD) in the real-world setting. The REBA study (real-world experience with brolucizumab in wet AMD) was a retrospective, observational, multicentric study that included 78 consecutive patients (105 eyes), with neovascular AMD, who received brolucizumab therapy. Both treatment-naive and switch-therapy patients were included. Switch therapy was based either on fluid recurrence, fluid recalcitrance, or inability to extend beyond q4/q6. All relevant data were collected. The primary outcome measure was change in best-corrected visual acuity (BCVA) over time. Secondary outcome measures included determination of change in central subfield thickness (CST) and complications. The mean baseline BCVA was 49.4 ± 5.4 letters and 40 ± 3.2 letters, and corresponding mean BCVA gain was +11.9 ± 3.9 letters (p = 0.011) and +10.4 ± 4.8 letters (p = 0.014) in the treatment-naive and switch-therapy groups, respectively. The change in CST was significantly decreased in the treatment-naive (p = 0.021) and the switch-therapy (p = 0.013) groups. The mean follow-up was 10.4 months in both groups. One patient in the switch-therapy group developed vascular occlusion and another a macular hole after the fifth brolucizumab injection. Both patients recovered uneventfully. In conclusion, patients showed a very good anatomical and functional response to brolucizumab therapy in the real world, regardless of prior treatment status, until the end of the follow-up period. Two significant untoward events were noted.

POS0594 MEANINGFUL IMPROVEMENT AND WORSENING IN PATIENTS WHO DO NOT ACHIEVE LDA AND SWITCH THERAPY TO A NEW BIOLOGIC OR TARGETED THERAPY: RESULTS FROM THE CORRONA REGISTRY

Background:Guidelines recommend adjusting therapy in patients with rheumatoid arthritis (RA) who fail to reach and sustain low disease activity (LDA) or remission (disease control). Many factors can affect the decision to change therapy, including the potential for improvement as well as the fear of potential worsening or loss of improvement already achieved. Although data exist on response to treatment in patients who switch therapy, data addressing the likelihood of worsening are limited.Objectives:The aim of this analysis was to describe the demographic, clinical characteristics, and change in clinical outcomes in patients on biologic/targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) who had some improvement in clinical disease activity index (CDAI) but did not achieve LDA after ~ 6-12 months of treatment and then switched to a different b/tsDMARD.Methods:This study included adult inadequately responding RA patients from the CORRONA registry who: (1) started a biologic or Janus kinase inhibitor (JAKi) between January 2010 to November 2020 (V1), (2) had any CDAI improvement (i.e., decrease ≥1 unit) but were not in LDA or remission at a subsequent visit (baseline [BL]) occurring 3 to 15 months after V1; (3) had a third visit (follow-up [F/U]) 6 (±3) months after BL with a valid CDAI measure; (4) switched therapy at the BL or between BL and F/U, with the switch occurring at least 3 months prior to the F/U. CDAI >10 and ≤22 was defined as moderate disease activity (MDA) and CDAI >22 was defined as high disease activity (HDA). Two thresholds of change in CDAI (≥6 and ≥12 units) were used to define meaningful improvement and meaningful worsening after the switch. If there was no meaningful improvement or meaningful worsening, this was considered as no meaningful change (-5 to +5 for 6 units change and -11 to +11 for 12 units change). These thresholds for meaningful change were set for all switchers regardless of their pre-switch CDAI value. Descriptive statistics were generated for demographic and clinical characteristics for the switchers at BL, and the change of clinical outcomes was evaluated from BL to F/U.Results:Of the 1,224 patients fulfilling the inclusion criteria, 93 (7.6%) switched therapy and 1,131 (92.4%) did not switch therampy after not achieving an adequate response on the initial b/tsDMARD. At BL, 42.5% and 70.0% of patients had no meaningful improvement to their prior therapy based on ≥6 and ≥12-unit change, respectively; mean (SD) age was 53.1 (14.0) years; duration of RA 10.7 (10.4) years; CDAI 22.2 (10.8); 81.7% were female; 64.5% had MDA, 35.5% had HDA; 21.5 % reported being disabled, 24.7% were current smokers, and 50% were obese. In terms of prior biologic use 57.0%, 22.6%, and 20.4% had been on 1, 2, and 3+, respectively. From BL to F/U, meaningful worsening occurred in 30.1% and 12.9% using a threshold of 6 and 12, respectively, with the remaining patients experiencing meaningful improvement or no meaningful change (Figure 1).Figure 1.Meaningful Worsening, Meaningful Improvement, and No Meaningful Change Based on CDAI Change Thresholds of ≥6 and ≥12 From BL to F/U (N=93)Conclusion:In our analysis, a large proportion of patients who initiated a biologic/JAKi and experienced some improvement but failed to attain LDA or remission, did not switch therapy within approximately a year. This analysis consisted of many patients who did not have a meaningful response to their prior biologic/JAKi, patients who had received multiple prior biologics, and a large portion of patients with poor prognostic factors. Despite this, the proportion of patients with meaningful worsening was low compared with most patients who had either meaningful improvement or no meaningful change. Additional research is warranted to understand the reasons for not switching and whether the likelihood of a meaningful change correlates with prior response, poor prognosis, or other factors.Acknowledgements:Amy Praestgaard (Sanofi) contributed to the statistical analysis for this abstract. Medical writing support for this abstract was provided by Krishna Kammari (Sanofi).Disclosure of Interests:Jeffrey Curtis Grant/research support from: and personal fees from AbbVie, Amgen, BMS, CORRONA, Eli Lily, Janssen, Myriad, Pfizer, Roche, Regeneron, Radius, UCB, outside the submitted work, Stefano Fiore Shareholder of: Sanofi, Employee of: Sanofi. In addition, he has a patent EP 19306553.9; USPTO #s 62/799,698; 62/851,474; 62/935,395 issued, Kerri Ford Shareholder of: Sanofi, Employee of: Sanofi, Judson Janak: None declared, Hong Chang: None declared, Dimitrios A Pappas Employee of: CORRONA LLC. He has previously acted as a consultant for Sanofi, Abbvie, Gtech Roche Hellas, and Novartis. He has an equity interest in CORRONA LLC. and is on the Board of directors of the CORRONA research foundation, Taylor Blachley: None declared, Kelechi Emeanuru: None declared, Vivian Bykerk Grant/research support from: reports grants from Amgen, BMS, UCB, and Novartis were given to institution, that grants from the NIH, PCORI, and CIHR were given to institutions which whom she is affiliated, and that she has received personal fees from Amgen, Gilead, BMS, Pfizer, Sanofi Aventis, Roche, UCB and Regeneron, outside the submitted work.

Fecal Microbiota Transplantation is a Promising Switch Therapy for Patients with Prior Failure of Infliximab in Crohn’s Disease

Background: How to handle patients with anti-tumor necrosis factor (anti-TNF) failure was a common challenge to clinicians in Crohn’s disease (CD). The present study is dedicated to clarifying whether fecal microbiota transplantation (FMT) could be a switch therapy for patients with prior failure of infiiximab (IFX) in CD in a long-term observation.Methods: Thirty-six patients with CD who had prior failure of IFX were recruited from January 2013 to December 2019. The “one-hour FMT protocol” was followed in all patients. All patients received the first course of FMT through gastroscopy or mid-gut transendoscopic enteral tubing. After April 2014, the methodology of FMT was coined as washed microbiota transplantation (WMT), substituting for the manual methods, which is dependent on the automatic microbiota purification system and the washing process. The primary endpoint of this study was the clinical remission at one month and one year after FMT. The secondary endpoint was the safety of FMT in the short and long term, and clinical factors as predictors for long-term efficacy of FMT. Clinical factors as independent predictors of efficacy from FMT were isolated using univariable and multivariable logistic regression analysis.Results: There was no significant difference in the rates of clinical response and remission between IFX treatment stage and FMT treatment stage (at one month, three months and six months after administration) (p > 0.05). Compared with those of 19 patients who achieved clinical remission at one month after FMT, the rates of clinical relapse were significantly higher in 18 patients who achieved clinical remission at one month after IFX [log-rank test p = 0.0009 HR = 3.081 (95% CI 1.43–6.639)]. Multivariate analysis revealed that the gender of donor (95% CI: 0.001–0.72; p = 0.031) was an independent predictor of efficacy at one year after FMT. No serious adverse events (AEs) associated with FMT were observed during and after FMT. The rate of AEs was significantly lower in group FMT than that in group IFX (p = 0.002).Conclusion: The present findings first time provided the evidence for clinicians to consider FMT into practice as an alternative switch therapy for patients with prior loss of response or intolerance to IFX in CD.Clinical Trial Registration:https://clinicaltrials.gov, identifier NCT01793831

Luaran Klinis dan Analisis Biaya Konversi dari Antibiotik Intravena Ke Oral pada Pasien Community Acquired Pneumonia di Rumah Sakit Akademik Universitas Gadjah Mada

Beberapa studi mengusulkan konversi terapi antibiotik intravena ke oral untuk menurunkan lama rawat inap dan biaya dalam pengobatan Community Acquired Pneumonia (CAP) yang masih menjadi masalah di Indonesia. Penelitian ini bertujuan untuk mengetahui gambaran tentang praktik konversi antibiotik intravena ke oral pada pasien CAP serta menganalisis biaya dari terapi tersebut. Penelitian ini dilakukan dengan rancangan cross sectional terhadap pasien CAP di RSA UGM. Data yang diambil berupa rekam medik pasien rawat inap periode Januari 2017-Desember 2019 yang selanjutnya dibagi ke dalam dua kelompok yakni kelompok konversi ≤ hari ke-3 dan kelompok konversi > hari ke-3. Hasil penelitian menunjukan bahwa switch therapy merupakan jenis konversi paling banyak digunakan (60,6%). Merujuk pada luaran klinis, terdapat perbedaan yang signifikan (p<0,05) antara kelompok antibiotik intravena konversi ≤ hari ke-3 dan kelompok antibiotik antibiotik intravena konversi >hari ke 3 terhadap LOS (4,21±0,99 vs 5,65±1,40). Hal yang sama terjadi pada analisis biaya, yang juga menunjukan perbedaan siginifikan (p<0,05) antara kelompok antibiotik intravena konversi ≤ hari ke-3 dan kelompok antibiotik intravena konversi >hari ke-3 terhadap biaya antibiotik dengan biaya total masing-masing Rp.126.022,33 vs Rp.274.283,82 dan Rp.2.610.283,66 vs Rp.3.696.681,06. Konversi antibiotik intravena ke oral ≤ hari ke-3 menghasilkan lama rawat inap yang lebih rendah dan penghematan biaya pengobatan.

Antimicrobial switch therapy in pediatric patients hospitalized by uncomplicated community-acquired pneumonia

Objective: To evaluate the duration of intravenous (IV) antibiotic therapy and the practice of switch therapy to oral in the treatment of children aged 2 months to 5 years with uncomplicated severe community acquired pneumonia (CAP) in a pediatric public hospital. Methods: Retrospective, observational and cross-sectional study in which patients who started IV ampicillin treatment were selected. The patients were classified as “eligible” or “ineligible” to undergo switch therapy after 48 and 72 hours of hospitalization according to clinical criteria. Patients with length of stay <or ≥7 days were compared regarding demographic characteristics and antibiotic therapy, considering p <0.05 significant. Results: Eighty-six patients were evaluated, aged 14.4 (IQR: 10.8-22.7) months. The duration of IV therapy was 4 (IQR: 3-6) days; 56% of patients were classified as eligible for switch therapy within 48h and 74% as eligible within 72h. However, only 19 cases (22%) underwent switch therapy at the appropriate time. The main reason for the transition was the accidental loss of venous access (61%). The group with length of stay <7 days had a higher rate of switch and, consequently, shorter IV therapy duration (p <0.01). Conclusion: The switch therapy in the first 48 to 72 hours is not routinely used in the clinical practice in patients hospitalized with CAP. The findings warn of the need for institutional initiatives on this practice, aiming at improving the quality of care with shorter IV therapy duration and impact on length of hospital stay.