Portuguese recommendations for the use of biological therapies in patients with axial spondyloarthritis – 2016 update

Authors

Pedro Machado; Marcos Cerqueira; Pedro Ávila-Ribeiro; Renata Aguiar; Alexandra Bernardo; Alexandre Sepriano; Ana Águeda; Ana Cordeiro; Ana Raposo; Ana M Rodrigues; Anabela Barcelos; Armando Malcata; Carina Lopes; Cláudia C Vaz; Dolores Nour; Fátima Godinho; Fernando Alvarenga; Fernando Pimentel-Santos; Helena Canhão; Helena Santos; Inês Cunha; Joana Sousa Neves; João Eurico Fonseca; João Lagoas Gomes; José Tavares-Costa; Lúcia Costa; Luís Cunha-Miranda; Luís Maurício; Margarida Cruz; Maria Carmo Afonso; Maria José Santos; Miguel Bernardes; Paula Valente; Ricardo Figueira; Sofia Pimenta; Sofia Ramiro; Teresa Pedrosa; Tiago Afonso Costa; Elsa Vieira-Sousa;

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Objective: To update the recommendations for the treatment of axial spondyloarthritis (axSpA) with biological therapies, endorsed by the Portuguese Society of Rheumatology. Methods: These treatment recommendations were formulated by Portuguese rheumatologists based on literature evidence and consensus opinion. At a national meeting, the 7 recommendations included in this document were discussed and updated. A draft of the full text of the recommendations was then circulated and suggestions were incorporated. A final version was again circulated before publication and the level of agreement among Portuguese Rheumatologists was anonymously assessed using an online survey. Results: A consensus was achieved regarding the initiation, assessment of response and switching of biological therapies in patients with axSpA. In total, seven recommendations were produced. The first recommendation is a general statement indicating that biological therapy is not a first-line drug treatment option and should only be used after conventional treatment has failed. The second recommendation is also a general statement about the broad concept of axSpA adopted by these recommendations that includes both non-radiographic and radiographic axSpA. Recommendations 3 to 7 deal with the definition of active disease (including the recommended threshold of 2.1 for the Ankylosing Spondylitis Disease Activity Score [ASDAS] or the threshold of 4 [0-10 scale] for the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]), conventional treatment failure (nonsteroidal anti-inflammatory drugs being the first-line drug treatment), assessment of response to treatment (based on an ASDAS improvement of at least 1.1 units or a BASDAI improvement of at least 2 units [0-10 scale] or at least 50%), and strategy in the presence of an inadequate response (where switching is recommended) or in the presence of long-term remission (where a process of biological therapy optimization can be considered, either a gradual increase in the interval between doses or a decrease of each dose of the biological therapy). Conclusion: These recommendations may be used for guidance in deciding which patients with axSpA should be treated with biological therapies. They cover a rapidly evolving area of therapeutic intervention. As more evidence becomes available and more biological therapies are licensed, these recommendations will have to be updated.

Pedro Machado
University College London, London, UK

Marcos Cerqueira
Rheumatology Department, Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos, Ponte de Lima, Portugal

Pedro Ávila-Ribeiro
Rheumatology and Metabolic Bone Diseases Department, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria, Lisboa, Portugal

Renata Aguiar
Rheumatology Department, Centro Hospitalar do Baixo Vouga, Hospital de Aveiro, Aveiro, Portugal

Alexandra Bernardo
Rheumatology Department, Centro Hospitalar de S. João, Porto, Portugal

Alexandre Sepriano
NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal

Ana Águeda
Rheumatology Department, Centro Hospitalar do Baixo Vouga, Hospital de Aveiro, Aveiro, Portugal

Ana Cordeiro
Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal

Ana Raposo
Rheumatology Department, Centro Hospitalar de Trás-os-Montes e Alto Douro, Vila Real, Portugal

Ana M Rodrigues
CEDOC, EpiDoC Unit, NOVA Medical School and National School of Public Health, Universidade Nova de Lisboa, Lisboa, Portugal

Anabela Barcelos
Rheumatology Department, Centro Hospitalar do Baixo Vouga, Hospital de Aveiro, Aveiro, Portugal

Armando Malcata
Rheumatology Department, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

Carina Lopes
CEDOC, EpiDoC Unit, NOVA Medical School and National School of Public Health, Universidade Nova de Lisboa; Rheumatology Department, Centro Hospitalar Lisboa Ocidental, Hospital de Egas Moniz, Lisboa, Portugal

Cláudia C Vaz
Rheumatology Department, Unidade Local de Saúde da Guarda, Guarda, Portugal

Dolores Nour
Clínica Intregare Terapêutica - Fortaleza: Clínica da Família, Fortaleza, Brasil

Fátima Godinho
Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal

Fernando Alvarenga
Consultório Privado de Reumatologia, Portugal

Fernando Pimentel-Santos
CEDOC, EpiDoC Unit, NOVA Medical School and National School of Public Health, Universidade Nova de Lisboa; Rheumatology Department, Centro Hospitalar Lisboa Ocidental, Hospital de Egas Moniz, Lisboa, Portugal

Helena Canhão
CEDOC, EpiDoC Unit, NOVA Medical School and National School of Public Health, Universidade Nova de Lisboa, Lisboa, Portugal

Helena Santos
Instituto Português de Reumatologia, Lisboa, Portugal

Inês Cunha
Rheumatology Department, Centro Hospitalar do Baixo Vouga, Hospital de Aveiro, Aveiro, Portugal

Joana Sousa Neves
Rheumatology Department, Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos, Ponte de Lima, Portugal

João Eurico Fonseca
Rheumatology and Metabolic Bone Diseases Department, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria; Rheumatology Research Unit, Instituto de Medicina Molecular, Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre, Lisbon, P

João Lagoas Gomes
Rheumatology Department, Centro Hospitalar Lisboa Ocidental, Hospital de Egas Moniz, Lisboa, Portugal

José Tavares-Costa
Rheumatology Department, Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos, Ponte de Lima, Portugal

Lúcia Costa
Rheumatology Department, Centro Hospitalar de S. João, Porto, Portugal

Luís Cunha-Miranda
Instituto Português de Reumatologia, Lisboa, Portugal

Luís Maurício
Consultório Privado de Reumatologia, Portugal

Margarida Cruz
Consultório Privado de Reumatologia, Portugal

Maria Carmo Afonso
Rheumatology Department, Unidade Local de Saúde do Alto Minho, Hospital Conde de Bertiandos, Ponte de Lima, Portugal

Maria José Santos
Rheumatology Department, Hospital Garcia de Orta, Almada, Portugal

Miguel Bernardes
Rheumatology Department, Centro Hospitalar de S. João, Porto, Portugal

Paula Valente
Centro Hospitalar de Entre o Douro e Vouga, Hospital de São Sebastião, Santa Maria da Feira, Portugal

Ricardo Figueira
Centro Hospitalar do Funchal, Funchal, Madeira, Portugal

Sofia Pimenta
Rheumatology Department, Centro Hospitalar de S. João, Porto, Portugal

Sofia Ramiro
NOVA Medical School, Universidade Nova de Lisboa; Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands

Teresa Pedrosa
Rheumatology Department, Centro Hospitalar Lisboa Ocidental, Hospital de Egas Moniz, Lisboa, Portugal

Tiago Afonso Costa
Rheumatology Department, Centro Hospitalar Lisboa Ocidental, Hospital de Egas Moniz, Lisboa, Portugal

Elsa Vieira-Sousa
Rheumatology and Metabolic Bone Diseases Department, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria; Rheumatology Research Unit, Instituto de Medicina Molecular, Faculty of Medicine, University of Lisbon, Lisbon Academic Medical Centre, Lisbon, P

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