Correction to: PANLAR consensus statement on biosimilars.

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. Roa" and "J. F. Diaz-Coto" instead of "L. Diaz Soto".

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.

Is the Treatment with Biological or Non-biological DMARDS a Modifier of Periodontal Condition in Patients with Rheumatoid Arthritis?

BACKGROUND AND OBJECTIVE: Experimental models suggest the use of different therapy protocols in rheumatoid arthritis (RA) as modulators on periodontal condition. This study evaluated the effects of conventional drug treatment and anti-TNF therapy in patients with RA on microbiological and periodontal condition, establishing the association of markers of periodontal infection with indexes of rheumatic activity. MATERIALS AND METHODS: One hundred seventy nine individuals with RA were evaluated (62 with anti-TNF-. and 115 with only DMARDs). The periodontal evaluation included plaque and gingival indexes, bleeding on probing (BOP), clinical attachment loss (CAL), pocket depth (PD) and subgingival plaque samples for microbiological analysis. Rheumatologic evaluations included a clinical examination, rheumatoid factor (RF), antibodies against cyclic-citrullinated peptides (ACPAs), and activity markers (DAS28-ERS), high sensitive C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR). RESULTS: Anti-TNF-alpha therapy influenced periodontal microbiota with a higher frequency of T. denticola (p=0.01). Methotrexate combined with leflunomide exhibited a higher extension of CAL (p=0.005), and anti-TNF-alpha therapy with methotrexate was associated with a lower extension of CAL (p=0.05). The use of corticosteroids exerted a protective effect on the number of teeth (p=0.027). The type of DMARD affected P. gingivalis, T. forsythia and E. nodatum presence. Elevated ACPAs titers were associated with the presence of red complex periodontal pathogens (p=0.025). Bleeding on probing was associated with elevated CPR levels (p=0.05), and ESR was associated with a greater PD (p=0.044) and presence of red complex (p=0.030). CONCLUSION: Different pharmacological treatments for RA affect the clinical condition and subgingival microbiota.

Clinical outcomes in a cohort of Colombian patients with rheumatoid arthritis treated with Etanar, a new biologic type rhTNFR:Fc.

OBJECTIVES: To evaluate the clinical response at 12 month in a cohort of patients with rheumatoid arthritis treated with Etanar (rhTNFR:Fc), and to register the occurrence of adverse effects. METHODS: This is a multicentre observational cohort study. It included patients over 18 years of age with an active rheumatoid arthritis diagnosis for which the treating physician had begun a treatment scheme of 25 mg of subcutaneous etanercept (Etanar ® 25 mg: biologic type rhTNFR:Fc), twice per week. Follow-up was done during 12 months, with assessments at weeks 12, 24, 36 and 48. Evaluated outcomes included tender joint count, swollen joint count, ACR20, ACR50, ACR70, HAQ and DAS28. RESULTS: One-hundred and five (105) subjects were entered into the cohort. The median of tender and swollen joint count, ranged from 19 and 14, respectively at onset to 1 at the 12th month. By month 12, 90.5% of the subjects reached ACR20, 86% ACR50, and 65% ACR70. The median of DAS28 went from 4.7 to 2, and the median HAQ went from 1.3 to 0.2. The rate of adverse effects was 14 for every 100 persons per year. No serious adverse effects were reported. The most frequent were pruritus (5 cases), and rhinitis (3 cases). CONCLUSIONS: After a year of following up a patient cohort treated with etanercept 25 mg twice per week, significant clinical results were observed, resulting in adequate disease control in a high percentage of patients with an adequate level of safety.