Topical Tofacitinib: A Janus Kinase Inhibitor for the Treatment of Vitiligo in an Adolescent Patient.

Vitiligo is an autoimmune skin disease presenting with areas of depigmentation. Recent reports suggest that Janus kinase (JAK) inhibitors may be an effective therapy. In this case report, we show our experience with an adolescent patient with a long history of generalized and refractory vitiligo, for which treatment with topical tofacitinib, a JAK inhibitor, associated with phototherapy for 9 months, resulted in near complete repigmentation.

The landscape of systemic lupus erythematosus in Brazil: An expert panel review and recommendations.

Purpose: The objective of this review is to address the barriers limiting access to diagnosis and treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN) in Brazil, specifically for patients in the public healthcare system, arguably those with the least access to innovation.

Design: A selected panel of Brazilian experts in SLE/LN were provided with a series of relevant questions to address in a multi-day conference. During the conference, responses were discussed and edited by the entire group through numerous drafts and rounds of discussion until a consensus was achieved.

Successful treatment of ulcerated pyoderma gangrenosum with baricitinib, a novel JAK inhibitor.

Pyoderma gangrenosum manifests as an ulceration of the skin often associated with several systemic diseases. The diagnosis is usually made by exclusion criteria with suggestions made by clinical findings and histological features. It can occur any site but more common in the legs.

Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial.

Background: Belimumab is approved for the treatment of active systemic lupus erythematosus (SLE). Although clinical trials showed a favourable benefit-risk profile, numerical differences in the incidence of mortality and adverse events of special interest (AESIs) have been reported. We assessed the frequency of these events in patients with SLE receiving belimumab or placebo plus standard therapy.

Treatment of knee osteoarthritis with a new formulation of a fixed-dose combination of glucosamine sulfate and bovine chondroitin: a multicenter, randomized, single-blind, non-inferiority clinical trial.

Objectives: To compare the efficacy and safety of a new formulation of a fixed dose combination of glucosamine sulfate (GS; 1500 mg) and bovine chondroitin sulfate (CS; 1200 mg) versus the reference product (RP) in patients with knee osteoarthritis (OA).

Methods: In this multicenter, randomized, single-blind trial, 627 patients with knee osteoarthritis (OA)-Kellgren-Lawrence grades 2 or 3 and mean score ≥ 40 mm in the WOMAC pain subscale-were randomized to receive GS/CS or the RP for 24 weeks. The primary efficacy endpoint was the absolute change in WOMAC pain subscale score.

Atopic dermatitis: Tofacitinib, an option for refractory disease.

Atopic dermatitis (AD) is a common skin disease, associated with high burden impact in quality of live, in moderate-severe disease severity. Several targeted drugs are under development for AD. Here, we present a patient with refractory disease to systemic traditional immunosuppressive drugs, treated successfully with oral tofacitinib, with complete response.

Lupus low disease activity (SLE) in patients treated with belimumab: a single-center real-life experience (2016-2019).

Introduction: We have been conducting an evaluation of innovative therapies in patients with SLE during the past 15 years. We combine the results observed on extension studies from four different trials in patients receiving either intravenous or subcutaneous belimumab, and evaluated, in Caucasian and Black Brazilian patients.

Methods: Seventy-four patients were part of the study.

Knowledge gap about immune checkpoint inhibitors among rheumatologists and medical students: a survey.

Previous studies found that physicians working in developed countries in Europe and in the USA declared insufficient knowledge concerning immune-related adverse events (irAE) following use of immune checkpoint inhibitors (ICI) in cancer treatment. We determined this knowledge gap among rheumatologists and medical students (MS) in Brazil. A web-based structured survey or a direct interview was applied to 1428 board-certified Brazilian rheumatologists and an adapted questionnaire was sent to 840 undergraduate MS attending the last 2 years of Medical Schools in Fortaleza-CE, Brazil, in September 2019.

Efficacy and safety of Sandoz biosimilar rituximab for active rheumatoid arthritis: 52-week results from the randomized controlled ASSIST-RA trial.

Objectives: This report provides data for the extent of B cell depletion and recovery, efficacy, safety and immunogenicity of Sandoz rituximab (SDZ-RTX; GP2013; Rixathon®) compared with reference rituximab (Ref-RTX) up to week 52 of the ASSIST-RA study.

Methods: Patients were randomized to SDZ-RTX or Ref-RTX in combination with methotrexate according to the RTX label. The primary endpoint was analysed at week 24.

An excellent response to tofacitinib in a Brazilian adolescent patient with alopecia areata: A case report and a review of the literature.

Alopecia areata is a common autoimmune disease, with a negative impact in health-related quality of life, especially when affecting children and adolescents. Current medical therapies, mainly for severe disease, are not effective. There are no FDA (Food and Drug Administration)- or ANVISA (Agência Nacional de Vigilância Sanitária)-approved therapy for children with alopecia areata.

The future landscape of biosimilars in rheumatology: Where we are where we are going.

Introduction: The upcoming of biosimilars in rheumatic diseases have generated considerable interest throughout the past five years among pharmaceutical industries and regulatory agencies, their development is associated with considerable variation and heterogeneity on the variable requirements for license and marketing throughout the various continents.

Aim: In this article we reviewed the contents of the conference presented on the last XI International Conference in Autoimmunity in Lisbon.

Evidence: Truly biosimilars that followed requirements from stringent agencies are now available and licensed for infliximab, etanercept, adalimumab and rituximab but several compounds from the same mechanism of action are also being developed and are reviewed and the strengths of their evidence analized and discussed.

Efficacy and safety of a fixed-dose combination of nimesulide/pantoprazole compared to naproxen/esomeprazole for pain relief in patients with osteoarticular diseases and dyspeptic symptoms.

Purpose: This study investigated the safety and efficacy of fixed-dose combination tablets of naproxen/esomeprazole magnesium and nimesulide/pantoprazole to determine if both regimens are equally suited to relieve pain in patients with osteoarticular diseases and dyspeptic symptoms.

Methods: Patients were randomly assigned to receive either nimesulide/pantoprazole (100 mg/20 mg) twice daily or naproxen/esomeprazole magnesium (500 mg/20 mg) twice daily for 14 days. The primary endpoint was defined as the mean change in modified Western Ontario and McMaster Universities Osteoarthritis Index pain subscale.

Partnership for productive development of biosimilar products: perspectives of access to biological products in the Brazilian market.

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.

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product.