OBJECTIVE: To evaluate efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept and background methotrexate (MTX) in Japanese patients with rheumatoid arthritis (RA) and inadequate response to MTX (MTX-IR). METHODS: Double-dummy, double-blind study (NCT01001832); 118 adults with ≥ 10 swollen joints, ≥ 12 tender joints and C-reactive protein (CRP) ≥ 0.8 mg/dL randomized 1:1 to SC abatacept (125 mg weekly) with IV loading (∼10 mg/kg on Day 1), or IV abatacept (∼10 mg/kg monthly) for 169 days, both also receiving MTX (6-8 mg/week). Primary endpoint was Day 169 American College of Rheumatology (ACR)20 response; other efficacy endpoints, safety and immunogenicity were assessed. RESULTS: Similar proportions of patients achieved ACR20 responses at Day 169 with SC (91.5% [95% CI 81.3, 97.2]) and IV abatacept (83.1% [71.0, 91.6]). ACR50/70 responses, adjusted mean changes from baseline in Health Assessment Questionnaire-Disability Index scores and remission rates (28-joint Disease Activity Score [CRP] < 2.6) were also comparable between groups. Serious adverse event frequencies (5.1% vs. 3.4%) were similar with both formulations. One patient per group tested seropositive for immunogenicity. Weekly SC abatacept dosing achieved mean serum concentrations > 10 μg/mL (minimum therapeutic target). CONCLUSIONS: SC abatacept demonstrated comparable efficacy and safety to IV abatacept, with low immunogenicity rates, in MTX-IR Japanese patients with RA.
RCT Entities:
OBJECTIVE: To evaluate efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept and background methotrexate (MTX) in Japanese patients with rheumatoid arthritis (RA) and inadequate response to MTX (MTX-IR). METHODS: Double-dummy, double-blind study (NCT01001832); 118 adults with ≥ 10 swollen joints, ≥ 12 tender joints and C-reactive protein (CRP) ≥ 0.8 mg/dL randomized 1:1 to SC abatacept (125 mg weekly) with IV loading (∼10 mg/kg on Day 1), or IV abatacept (∼10 mg/kg monthly) for 169 days, both also receiving MTX (6-8 mg/week). Primary endpoint was Day 169 American College of Rheumatology (ACR)20 response; other efficacy endpoints, safety and immunogenicity were assessed. RESULTS: Similar proportions of patients achieved ACR20 responses at Day 169 with SC (91.5% [95% CI 81.3, 97.2]) and IV abatacept (83.1% [71.0, 91.6]). ACR50/70 responses, adjusted mean changes from baseline in Health Assessment Questionnaire-Disability Index scores and remission rates (28-joint Disease Activity Score [CRP] < 2.6) were also comparable between groups. Serious adverse event frequencies (5.1% vs. 3.4%) were similar with both formulations. One patient per group tested seropositive for immunogenicity. Weekly SC abatacept dosing achieved mean serum concentrations > 10 μg/mL (minimum therapeutic target). CONCLUSIONS: SC abatacept demonstrated comparable efficacy and safety to IV abatacept, with low immunogenicity rates, in MTX-IR Japanese patients with RA.
Authors: Charlotte Krieckaert; Borja Hernández-Breijo; Johanna Elin Gehin; Guillaume le Mélédo; Alejandro Balsa; Meghna Jani; Denis Mulleman; Victoria Navarro-Compan; Gertjan Wolbink; John Isaac; Astrid van Tubergen Journal: RMD Open Date: 2022-06
Authors: Hermine I Brunner; Nikolay Tzaribachev; Gabriel Vega-Cornejo; Ingrid Louw; Alberto Berman; Inmaculada Calvo Penadés; Jordi Antón; Francisco Ávila-Zapata; Rubén Cuttica; Gerd Horneff; Ivan Foeldvari; Vladimir Keltsev; Daniel J Kingsbury; Diego Oscar Viola; Rik Joos; Bernard Lauwerys; Maria Eliana Paz Gastañaga; Maria Elena Rama; Carine Wouters; John Bohnsack; Johannes Breedt; Michel Fischbach; Thomas Lutz; Kirsten Minden; Tatiana Miraval; Mahmood M T M Ally; Nadina Rubio-Pérez; Elisabeth Solau Gervais; Riana van Zyl; Xiaohui Li; Marleen Nys; Robert Wong; Subhashis Banerjee; Daniel J Lovell; Alberto Martini; Nicolino Ruperto Journal: Arthritis Rheumatol Date: 2018-05-20 Impact factor: 10.995