Which Strategy is More Effective in Patients with Rheumatoid Arthritis (RA) and Metotrexate Failure: Adding Leflunomide or TNFi?
Author(s)
Enzo Fraga Aguiar, MD Student1, Alisson Aliel Vigano Pugliesi, Ph.D2, Lucas Castro Pires, MD2, Cleandro Pires Albuquerque, Ph.D3, Vitor Alves Cruz, Ph.D4, Manoel Barros Bertolo, Ph.D2, Ana Paula Monteiro Gomides Reis, Ph.D5, Rina Dalva Neubarth Giorgi, Ph.D6, Leticia Rocha Pereira, MSc7, Sebastião Cesar Radominski, Ph.D8, Ivanio Alves Pereira, Ph.D9, Maria Fernanda Resende Guimarães, Ph.D10, Paulo Louzada Junior, Ph.D11, Maria de Fátima Lobato da Cunha Sauma, Ph.D12, Karina Rossi Bonfiglioli, Ph.D13, Claiton Viegas Brenol, Ph.D14, Licia Maria Henrique Mota, Ph.D3, Luiz Sérgio Fernandes de Carvalho, PhD1, Geraldo da Rocha Castelar Pinheiro, Ph.D7.
1Universidade Católica de Brasília, Brasilia, Brazil, 2Unicamp, Campinas, Brazil, 3Brasilia University, Brasilia, Brazil, 4Goias Federal University, Goias, Brazil, 5Centro Universitário de Brasilia, Brasilia, Brazil, 6Hospital do Servidor Publico Estadual de São Paulo, São Paulo, Brazil, 7Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil, 8Parana Federal University, Curitiba, Brazil, 9Santa Catarina Federal University, Florianópolis, Brazil, 10Minas Gerais Federal University, Belo Horizonte, Brazil, 11Universidade de São Paulo, Ribeirão Preto, Brazil, 12Pará Federal University, Belém, Brazil, 13Universidade de São Paulo, São Paulo, Brazil, 14Universidade Federal do Rio Grande do Sul, Porto alegre, Brazil.
1Universidade Católica de Brasília, Brasilia, Brazil, 2Unicamp, Campinas, Brazil, 3Brasilia University, Brasilia, Brazil, 4Goias Federal University, Goias, Brazil, 5Centro Universitário de Brasilia, Brasilia, Brazil, 6Hospital do Servidor Publico Estadual de São Paulo, São Paulo, Brazil, 7Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil, 8Parana Federal University, Curitiba, Brazil, 9Santa Catarina Federal University, Florianópolis, Brazil, 10Minas Gerais Federal University, Belo Horizonte, Brazil, 11Universidade de São Paulo, Ribeirão Preto, Brazil, 12Pará Federal University, Belém, Brazil, 13Universidade de São Paulo, São Paulo, Brazil, 14Universidade Federal do Rio Grande do Sul, Porto alegre, Brazil.
OBJECTIVES: This study aimed to carry out a comparative effectiveness evaluation of two strategies for patients with RA who failed MTX therapy: MTX + Leflunomide versus MTX + TNFi.
METHODS: The REAL study enrolled 1,115 patients from 11 Brazilian hospitals between 2015 and 2016. Patients with RA underwent three visits over a period of one year. A post hoc analysis was performed to compare the effectiveness of the two therapeutic strategies: group 1 (MTX + TNFi) and group 2 (MTX + Leflunomide). Disease activity was measured using the CDAI, and functional status was measured using the HAQ. A comparison was made between the two treatment strategies, with at least a six-month interval between the assessments. Statistical analyses included the Mann-Whitney U test, T-test, Chi-square test, and Fisher's exact test, as appropriate.
RESULTS: In total, 107 patients were eligible for inclusion in the analysis. The majority of patients were female (89 %) in group 1 and 84% in group 2. Rheumatoid Factor positivity was observed in 84% of patients in Group 1 and 81% in Group 2. At baseline, no statistically significant differences were found between the groups in HAQ or CDAI scores. These differences persisted throughout the study period regardless of the treatment used. Delta HAQ score: Group 1 (MTX + TNFi): Mean reduction of 0.28 (SD 0.61), Group 2 (MTX + Leflunomide), mean reduction of 0.42 (SD 0.92), p = 0.3; Delta CDAI with a mean reduction of 4 points in group 1 (SD 14), the same number in group 2 (SD 16), with a p-value of 0.9.
CONCLUSIONS: In the population studied, no significant differences in clinical effectiveness were found between the MTX + Leflunomide and MTX + TNFi strategies for patients with RA who failed MTX.
METHODS: The REAL study enrolled 1,115 patients from 11 Brazilian hospitals between 2015 and 2016. Patients with RA underwent three visits over a period of one year. A post hoc analysis was performed to compare the effectiveness of the two therapeutic strategies: group 1 (MTX + TNFi) and group 2 (MTX + Leflunomide). Disease activity was measured using the CDAI, and functional status was measured using the HAQ. A comparison was made between the two treatment strategies, with at least a six-month interval between the assessments. Statistical analyses included the Mann-Whitney U test, T-test, Chi-square test, and Fisher's exact test, as appropriate.
RESULTS: In total, 107 patients were eligible for inclusion in the analysis. The majority of patients were female (89 %) in group 1 and 84% in group 2. Rheumatoid Factor positivity was observed in 84% of patients in Group 1 and 81% in Group 2. At baseline, no statistically significant differences were found between the groups in HAQ or CDAI scores. These differences persisted throughout the study period regardless of the treatment used. Delta HAQ score: Group 1 (MTX + TNFi): Mean reduction of 0.28 (SD 0.61), Group 2 (MTX + Leflunomide), mean reduction of 0.42 (SD 0.92), p = 0.3; Delta CDAI with a mean reduction of 4 points in group 1 (SD 14), the same number in group 2 (SD 16), with a p-value of 0.9.
CONCLUSIONS: In the population studied, no significant differences in clinical effectiveness were found between the MTX + Leflunomide and MTX + TNFi strategies for patients with RA who failed MTX.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO173
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)