Valderilio F Azevedo | Universidade Federal do Paraná (original) (raw)

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Papers by Valderilio F Azevedo

Current Pharmaceutical Design, Feb 15, 2018

BACKGROUND Infliximab biosimilars are the first biosimilars of monoclonal antibodies approved by ... more BACKGROUND Infliximab biosimilars are the first biosimilars of monoclonal antibodies approved by the main regulatory agencies. Up to the present day, two infliximab biosimilars have been approved: CT-P13 (Celltrion), and SB2 (Biogen), but other companies have been developing candidate infliximab biosimilars that are on clinical trials: PF 06438179 (Pfizer), the ABP710 (bioCentury/Amgen) the BCD055 (JSC Biocad Russica) and BOW015 (Epirus). METHODS We have made a literature search in MedLine database using the key words [Infliximab] and [biosimilars] and [rheumatic diseases] and [rheumatisms]. We have also made a search in the clinicaltrials.org website. CONCLUSIONS Clinical data published so far have provided important evidence on long-term efficacy and safety, immunogenicity and switching, supporting the use of CT-P13 and SB2 for the treatment of rheumatic diseases. In addition, the European experience has proved the economic advantages of the incorporation of infliximab biosimilars in clinical practice. Despite the widespread use of infliximab biosimilars there is still a lack of data regarding interchangeability between reference products and biosimilars.

Journal of Bioequivalence & Bioavailability, Jul 15, 2013

Einstein (São Paulo), Sep 17, 2018

The manufacturing process for biological products is complex, expensive and critical to the final... more The manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the yearly budget for the Brazilian public health system. As the patents of biological products expire, several biosimilars are developed. However, there are concerns regarding their efficacy and safety; therefore, the regulatory agencies establish rules to approve and monitor these products. In Brazil, partnership programs between national government-owned companies and private technology holders have been implemented, aiming at knowledge sharing, capacity-building and technological transfer. Such partnerships locally promote manufacturing of these strategic drugs at reduced costs to the public health system. These agreements offer mutual advantages to both the government and patent holders: for the former, a biotechnological development flow is established and enables potential cost reduction and self-sufficient production; whereas for the latter, exclusive sales of the product are ensured during technological transfer, for a fixed period.

Revista Brasileira De Reumatologia, 2013

Revista Brasileira De Reumatologia, Aug 1, 2004

Sampaio-Barros PD, Conde RA, Donadi EA, et al: Undifferentiated spondyloarthropathies in Brazilia... more Sampaio-Barros PD, Conde RA, Donadi EA, et al: Undifferentiated spondyloarthropathies in Brazilians: importance of HLA-B27 and the B7-CREG alleles in characterization and disease progression (Espondiloartropatias indiferenciadas em brasileiros: importância do HLA B27 e dos alelos B7-CREG na caracterização e na progressão da doença)

Revista Bioética, 2011

Projeto acadêmico sem fins lucrativos desenvolvido no âmbito da iniciativa Acesso Aberto

Generics and Biosimilars Initiative journal, Dec 15, 2017

Revista Brasileira De Reumatologia, 1998

RMD Open, Jul 1, 2021

To cite: de Vlam K, Ogdie A, Bushmakin AG, et al. Median time to pain improvement and the impact ... more To cite: de Vlam K, Ogdie A, Bushmakin AG, et al. Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib. RMD Open 2021;7:e001609.

Considerations in medicine, Oct 1, 2017

Rheumatology, Jun 22, 2013

Arthritis & Rheumatology, 2020

ObjectiveTo evaluate fenebrutinib, an oral and highly selective noncovalent inhibitor of Bruton&#... more ObjectiveTo evaluate fenebrutinib, an oral and highly selective noncovalent inhibitor of Bruton's tyrosine kinase (BTK), in patients with active rheumatoid arthritis (RA).MethodsPatients with RA and an inadequate response to methotrexate (MTX) (cohort 1; n = 480) were randomized to receive fenebrutinib (50 mg once daily, 150 mg once daily, or 200 mg twice daily), adalimumab (40 mg every other week), or placebo. Patients with RA and an inadequate response to tumor necrosis factor inhibitors (cohort 2; n = 98) received fenebrutinib (200 mg twice daily) or placebo. Both cohorts continued MTX therapy.ResultsIn cohort 1, the percentages of patients in whom American College of Rheumatology 50% improvement criteria (ACR50) was achieved at week 12 were similar in the fenebrutinib 50 mg once daily and placebo groups, and were higher in the fenebrutinib 150 mg once daily group (28%) and 200 mg twice daily group (35%) than in the placebo group (15%) (P = 0.016 and P = 0.0003, respectively)...

Advances in Rheumatology, 2019

Background The Indian Takayasu Clinical Activity Score (ITAS2010) was developed in 2010 as an ass... more Background The Indian Takayasu Clinical Activity Score (ITAS2010) was developed in 2010 as an assessment tool for disease activity in patients with Takayasu arteritis (TA). It has since been widely used in different studies and in clinical practice for the management of patients with TA. The present study aims to translate the ITAS2010 into Brazilian Portuguese language and to validate it for use in clinical practice in Brazil. Methods For this cross-sectional study, the ITAS2010 was translated in accordance with the guidelines described by Beaton et al. and then applied with 27 patients with TA on three assessments by two rheumatologists working independently. To measure interrater agreement, the assessments were performed on the same day within approximately 1 hour. One of the rheumatologists performed a second evaluation of patients with TA within 7 to 14 days to measure intrarater agreement. Results The correlation coefficient for the ITAS2010 score between the two raters was hi...

Letters in Applied Microbiology, Apr 1, 2022

Jcr-journal of Clinical Rheumatology, Jun 14, 2022

Arthritis & Rheumatism, Sep 1, 2018

Background: Chronic persistent synovitis is commonly seen in inflammatory arthritis like RA where... more Background: Chronic persistent synovitis is commonly seen in inflammatory arthritis like RA where despite adequate DMARD therapy, few joints are chronically inflamed. They are the reason for increasing morbidity and poor functional status in these patients. Some patients show persistent synovitis despite intra-articular steroids and hence they is need to identify other drugs like sclerosant which can be of use in improving pain and functional status. Objectives: To compare the efficacy of Intra-articular steroid versus sclerosant in rheumatoid arthritis (RA) with persistent synovitis despite optimum dose of csDMARDS and to determine, if sclerosant is superior/noninferior to steroids. Methods: This is a single blinded-observational pilot study, conducted in Institute of Rheumatology, Madras Medical College for a period of 1 year. 20 patients with persistent synovitis (knees) despite optimum DMARD therapy are recruited as per inclusion and exclusion criteria. Disease and joint related activity and functional status are documented. Ethical committee approved the study. After getting written informed consent patients were randomized into two groups (A and B). Group A received IAS (Triamcinolone Acetonide) and group B received sclerosant (1% Polidocanol). They are assessed at 1, 4, 12 and 24 week and various parameters documented. The results are analysed with SPSS v22 software.Inclusion Criteria: 1. RA diagnosis according to ACR/EULAR2010 criteria in the age between 20 and 70years with persistent synovitis of knee. 2.Patients not willing for biological therapy. Exclusion Criteria: 1. Age <20->70yrs. 2. Pregnant & Lactating women. 3. Severe co-morbidities, clotting disorders and local infections. 4. Contraindications for intraarticular procedure. 5. Osteoarthritis and other arthritis and CTD. 6 Recent intra-articular injection within 3months. Results: 40 patients were recruited for the study, with 20 in each group. 45% patients in group A and 65% patients in group B, showed significant improvement in DAS28, CRP, VAS pain and function. VAS scores improved within 1 week and no adverse effects were noted. Both the interventions found to be effective in reducing the pre operative VAS pain and function scores. However, Mean VAS Scores after 1 week of sclerosant injection found to be lesser than that of steroid group and the difference was statistically significant (p<0.05). Conclusion: Intra-articular sclerosant (1%Polidocanol) is non-inferior to steroids in patients with persistent knee synovitis. It could be used as an effective alternative to steroids considering their side effect profile.