TY - JOUR
T1 - GO-DACT
T2 - 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
AU - Vieira-Sousa, Elsa
AU - Alves, Pedro
AU - Rodrigues, Ana M.
AU - Teixeira, Filipa
AU - Tavares-Costa, Jose
AU - Bernardo, Alexandra
AU - Pimenta, Sofia
AU - Pimentel-Santos, Fernando M.
AU - Gomes, João Lagoas
AU - Aguiar, Renata
AU - Pinto, Patrícia
AU - Videira, Taciana
AU - Catita, Cristina
AU - Santos, Helena
AU - Borges, Joana
AU - Sequeira, Graça
AU - Ribeiro, Célia
AU - Teixeira, Lídia
AU - Ávila-Ribeiro, Pedro
AU - Martins, Fernando M.
AU - Canhão, Helena
AU - McInnes, Iain B.
AU - Ribeiro, Ruy M.
AU - Fonseca, João Eurico
PY - 2020/4/1
Y1 - 2020/4/1
N2 - 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.
AB - 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.
KW - anti-TNF
KW - methotrexate
KW - outcomes research
KW - psoriatic arthritis
UR - http://www.scopus.com/inward/record.url?scp=85082037697&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2019-216500
DO - 10.1136/annrheumdis-2019-216500
M3 - Article
C2 - 32193187
AN - SCOPUS:85082037697
SN - 0003-4967
VL - 79
SP - 490
EP - 498
JO - Annals of the rheumatic diseases
JF - Annals of the rheumatic diseases
IS - 4
ER -