Article Text

Download PDFPDF

GO-DACT: a phase 3b randomised, double-blind, placebo-controlled trial of GOlimumab plus methotrexate (MTX) versus placebo plus MTX in improving DACTylitis in MTX-naive patients with psoriatic arthritis
  1. Elsa Vieira-Sousa1,2,
  2. Pedro Alves3,
  3. Ana M Rodrigues4,5,6,
  4. Filipa Teixeira7,
  5. Jose Tavares-Costa7,
  6. Alexandra Bernardo8,
  7. Sofia Pimenta8,
  8. Fernando M Pimentel-Santos9,10,
  9. João Lagoas Gomes9,
  10. Renata Aguiar11,
  11. Patrícia Pinto12,
  12. Taciana Videira12,
  13. Cristina Catita13,
  14. Helena Santos14,
  15. Joana Borges14,
  16. Graça Sequeira15,
  17. Célia Ribeiro15,
  18. Lídia Teixeira16,
  19. Pedro Ávila- Ribeiro1,2,
  20. Fernando M Martins17,
  21. Helena Canhão5,6,
  22. Iain B. McInnes18,
  23. Ruy M Ribeiro19,
  24. João Eurico Fonseca1,2
  1. 1 Rheumatology Research Unit, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal
  2. 2 Rheumatology Department, Hospital de Santa Maria, Lisboa, Portugal
  3. 3 Radiology Department, Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal
  4. 4 Rheumatology Unit, Hospital de Santo Espirito da Ilha Terceira EPER, Angra do Heroismo, Ilha Terceira, Portugal
  5. 5 Comprehensive Health Research Center (CHRC), Lisbon, Portugal
  6. 6 EpiDoc Unit, CEDOC, Nova Medical School, Lisbon, Portugal
  7. 7 Rheumatology Department, Unidade Local de Saúde do Alto Minho EPE, Ponte de Lima, Portugal
  8. 8 Rheumatology Department, Centro Hospitalar Universitário de São João, Porto, Portugal
  9. 9 Rheumatology Department, Hospital de Egas Moniz, Lisboa, Portugal
  10. 10 Centro de Estudos de Doenças Crónicas (CEDOC), NOVA Medical School, Universidade NOVA de Lisboa, Lisboa, Portugal
  11. 11 Rheumatology Department, Hospital Infante Dom Pedro, Aveiro, Portugal
  12. 12 Rheumatology Department, Hospital Centre of Vila Nova de Gaia Espinho, Vila Nova de Gaia, Porto, Portugal
  13. 13 Rheumatology Clinic, Hospital Particular do Algarve, Faro, Portugal
  14. 14 Rheumatology Department, Instituto Português de Reumatologia, Lisboa, Portugal
  15. 15 Rheumatology Department, Centro Hospitalar Universitário do Algarve EPE, Faro, Portugal
  16. 16 Rheumatology Department, Hospital Garcia de Orta EPE, Almada, Portugal
  17. 17 Portuguese Society of Rheumatology, Lisboa, Portugal
  18. 18 Institute of Infection, Immunity and Inflammation, University of Glasgow, Glasgow, UK
  19. 19 Laboratório de Biomatemática, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal
  1. Correspondence to Prof Elsa Vieira-Sousa, Universidade de Lisboa Instituto de Medicina Molecular, Lisboa 1649-028, Portugal; elsa-sousa{at}hotmail.com

Abstract

Objectives To assess the efficacy of golimumab in combination with methotrexate (MTX) versus MTX monotherapy in psoriatic arthritis (PsA) dactylitis.

Methods Multicentre, investigator-initiated, randomised, double-blind, placebo-controlled, parallel-design phase 3b trial in 11 Portuguese rheumatology centres. Patients with PsA along with active dactylitis and naive to MTX and biologic disease-modifying antirheumatic drugs (bDMARDs) were randomly assigned to golimumab or placebo, both in combination with MTX. The primary endpoint was Dactylitis Severity Score (DSS) change from baseline to week 24. Key secondary endpoints included DSS and Leeds Dactylitis Index (LDI) response, and changes from baseline in the LDI and MRI dactylitis score. Analysis was by intention-to-treat for the primary endpoint.

Results Twenty-one patients received golimumab plus MTX and 23 MTX monotherapy for 24 weeks. One patient from each arm discontinued. Patient inclusion was halted at 50% planned recruitment due to a favourable interim analysis. Median baseline DSS was 6 in both arms. By week 24, patients treated with golimumab plus MTX exhibited significantly greater improvements in DSS relative to MTX monotherapy (median change of 5 vs 2 points, respectively; p=0.026). In the golimumab plus MTX arm, significantly higher proportions of patients achieved at least 50% or 70% improvement in DSS and 20%, 50% or 70% improvement in LDI in comparison to MTX monotherapy.

Conclusions The combination of golimumab and MTX as first-line bDMARD therapy is superior to MTX monotherapy for the treatment of PsA dactylitis.

Trial registration number NCT02065713

  • psoriatic arthritis
  • anti-TNF
  • methotrexate
  • outcomes research
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

View Full Text

Statistics from Altmetric.com

Footnotes

  • Handling editor Josef S Smolen

  • Contributors All authors were involved in drafting, revising and approved the final version of this manuscript. Substantial contributions for study conception and design were made by

    EVS, HC, PA, FMM, AMR, IBM and JEF; RMR and EVS for data analysis; EVS, RMR, PT, AMR, FMM, HC, IBM and JEF for data interpretation; and EVS, PA, AMR, FT, JTC, AB, SP, FPS, JG, RA, TV, PP, CC, HS, JB, GS, CR, LT, PAR and JEF for acquisition of study data.

  • Competing interests EVS, FPS, JLG, LT, PAR and HC received grants from MSD. JEF received grants or personal fees from MSD, Abbvie, Biogen, Janssen, Lilly, Novartis, Pfizer, Roche, UCB and Sanofi. IBM received grants or personal fees from Celgene, Janssen, Novartis, Boerhinger Ingelheim, BMS, Abbvie, Lilly, GSK, Pfizer and UCB.

  • Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Ethics approval This trial was approved by the Portuguese Ethics Committee for Clinical Research (CEIC), National Authority of Medicines and Health Products (INFARMED) and National Data Protection Committee (CNPD).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.