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Certolizumab pegol with methotrexate leads to impressive outcomes for early rheumatoid arthritis patients, shows study presented at 2015 ACR/ARHP.
Certolizumab pegol with optimized methotrexate improved the endpoints of sustained remission, sustained low disease activity, structural damage and physical function in newly diagnosed rheumatoid arthritis patients, new research shows.
The study, by Michael Weinblatt, M.D., of Brigham’s and Women’s Hospital, Boston, was presented Nov. 9 at the 2015 ACR/ARHP annual meeting in San Francisco, Calif.
Certolizumab pegol, an anti-TNF therapy, has been approved worldwide for patients with active rheumatoid arthritis. While earlier research tested the efficacy of certolizumab pegol with methotrexate in established rheumatoid arthritis, the phase III C-EARLY trial evaluated the combination in DMARD naÃ¯ve patients with early, active rheumatoid arthritis and poor diagnostic factors.
The primary endpoint was the proportion of patients in sustained remission (DAS28[ESR] <2.6 at weeks 40 and 52), and the key secondary endpoint was sustained low disease activity (sLDA), defined as DAS28(ESR) ≤3.2 at week 40 sustained to week 52.
C-EARLY included 879 patients randomized 3:1 to certolizumab pegol (200 mg Q2W with methotrexate) or placebo (Q2W) with methotrexate. Mean age was 50 years old (77% female). A higher percentage of patients in the certolizumab pegol arm completed week 52 (75.8% versus 65.3%).
More patients in the certolizumab pegol and methotrexate arm achieved sustained remission (28.9%) as compared with the methotrexate arm (15.0%, p<0.001). Also, more patients in the certolizumab pegol arm had sLDA at weeks 40 and 52 (43.8% versus 28.6%, p<0.001).
Dr. Weinblatt reported further significant advantages for the certolizumab pegol group in ACR50 response at week 52 in relation to baseline (p=0.023), change from baseline in HAQ-DI at week 52 (p<0.001) and change from baseline in van der Heijde mTSS at week 52 (p<0.001).
Serious treatment-emergent adverse event rates were similar at 10.6% for the certolizumab pegol group and 9.2% for the methotrexate with placebo group. One death attributed to acute respiratory distress syndrome and active tuberculosis in the certolizumab pegol group was considered related to study medication.
“This is important for clinical practice because it now demonstrates that the introduction of an anti-TNF therapy, in this case certolizumab pegol, plus maintenance or therapeutic doses of methotrexate, attains a significant improvement in both low disease activity and remission over the course of a 52 week study. This gives comfort to the rheumatologist in introducing this regimen of anti-TNF therapy in patients with early disease,” Dr. Weinblatt said.
Abstract 968 - "Certolizumab Pegol in Combination with Methotrexate in DMARD-NaÃ¯ve Patients with Active, Severe, Progressive Rheumatoid Arthritis: Results from a Randomized, Double-Blind, Controlled Phase 3 Study," Michael Weinblatt MD. 2015 ACR/ARHP Annual Meeting. Nov. 8, 2015.