Current status of the rheumatologists’ workforce in Latin America: a PANLAR collaborative study

Clinical Rheumatology - Studies conducted by various scientific societies have shown that the demand for specialized rheumatology care is greater than the projected growth of the workforce. Our...     

Polyarticular arthritis secondary to Mycobacterium bovis infection: an unusual clinical presentation

We describe a 37-year-old Mexican man with incapacitating polyarticular arthritis secondary to Mycobacterium bovis infection. A dermatologist diagnosed psoriasis two years before admission. One year later due to symmetric ankle and knee arthritis, he was treated with three doses of etanercept. The arthritis extended to the carpus and metacarpophalangeal joints. Multifocal dactylitis and a left ankle periarticular abscess were documented. Concomitantly he developed fever, cough, and adenopathies. Ankle MRI showed osteomyelitis of the calcaneous with a posterior abscess. A CT-body scan documented mild pleural effusion that corresponded to an exudate. An ankle aspiration yielded a caseous fluid with acid-fast bacilli. Knee and ankle synovial biopsies documented a granulomatous synovitis. A lymph node biopsy showed granulomas with caseous necrosis. After 1 month, Mycobacterium bovis was isolated from these tissues. Antituberculous regimen was started with satisfactory response. Although largely eradicated, bovine tuberculosis still occurs. Nevertheless, the clinical presentation as polyarthritis is very uncommon and represents a diagnostic challenge.     

Correction to: PANLAR consensus statement on biosimilars

Clinical Rheumatology - The two co-authors of the mentioned above article were incorrect. The correct are authors should have been “P. A. Beltrán” instead of “P. A. B....     

PANLAR consensus statement on biosimilars

Introduction

Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications.

Objective

The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR).

Methods

Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited.

Results

Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics.

Conclusion

The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals.

Key Points

• Biologics have improved the treatment of rheumatic diseases.

• Their high cost limits access for many patients in both North America and Latin America.

• Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases.

• PANLAR presents its consensus on biosimilars in rheumatology