There have been 14 publications on certolizumab at the ACR 2015 Annual Meeting in San Francisco. For this blogpost (Part 1) I’ve picked only two studies for a specific reason as you will see later
Michael Weinblatt and colleages presented: “Certolizumab Pegol in Combination with Methotrexate in DMARD-Naïve Patients with Active, Severe, Progressive Rheumatoid Arthritis: Results from a Randomized, Double-Blind, Controlled Phase 3 Study”. The study is called C-EARLY and is a phase 3 study in DMARD-naïve patients with severe, active, progressive rheumatoid arthritis. The primary endpoint has been sustained DAS28(ESR) remission (sREM), defined as DAS28[ESR] ≤ 2.6 at both week 40 and week 52. Certolizumab reached this endpoint at a p value of < 0.001 (OR 2.3). Radiographic progression was assessed by the van der Heijde modified total Sharp score (mTSS). Conclusion: “CZP+MTX treatment of DMARD-naïve pts with active, severe, progressive RA resulted in a greater proportion of pts in sREM and sLDA; greater improvements in RA signs and symptoms; and inhibition of structural damage vs PBO+MTX. Safety profile of CZP+MTX was similar to PBO+MTX.”
Tatsuya Atsumi and colleagues looked at: “Clinical Benefit of 1-Year Certolizumab Pegol Treatment in MTX-Naïve, Early Rheumatoid Arthritis Patients Is Maintained after Discontinuation up to 1 Year”. Conclusion: “The clinical benefit of initial 1-year CZP treatment in MTX-naïve early RA patients was still observed after discontinuing CZP for an additional 1 year while continuing optimized MTX monotherapy.”
At the 20th of November UCB received a positive opinion by CHMP (Committee for Medicinal Products for Human Use ) of EMA (European Medicines Agency) for CIMZIA® (certolizumab pegol) to treat severe, active and progressive rheumatoid arthritis in DMARD-naïve patients. “ The positive opinion was based on period 1 of UCB’s Phase 3 C-EARLY™ study, which found that adding CIMZIA® to optimized methotrexate achieved statistically significant sustained remission and inhibition of radiographic progression (change from baseline in van der Heijde modified total Sharp score) at week 52 in DMARD-naïve patients with early, active RA.” So, I don’t think it will take long until this indication will be approved. We could argue on the differences between DMARD-naïve and MTX-naïve, but all in all, it would make it easier to use a biologic as early as needed.
Weinblatt M, Bingham C, Burmester G, Bykerk V, Furst DE, Mariette X, van der Heijde D, Tatla D, Arendt C, Mountian I, VanLunen B, Emery P. Certolizumab Pegol in Combination with Methotrexate in DMARD-Naïve Patients with Active, Severe, Progressive Rheumatoid Arthritis: Results from a Randomized, Double-Blind, Controlled Phase 3 Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/certolizumab-pegol-in-combination-with-methotrexate-in-dmard-naive-patients-with-active-severe-progressive-rheumatoid-arthritis-results-from-a-randomized-double-blind-controlled-phase-3-study/. Accessed December 4, 2015.
Atsumi T, Yamamoto K, Takeuchi T, Yamanaka H, Ishiguro N, Tanaka Y, Eguchi K, Watanabe A, Origasa H, Shoji T, Togo O, Okada T, van der Heijde D, Miyasaka N, Koike T. Clinical Benefit of 1-Year Certolizumab Pegol Treatment in MTX-Naïve, Early Rheumatoid Arthritis Patients Is Maintained after Discontinuation up to 1 Year [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/clinical-benefit-of-1-year-certolizumab-pegol-treatment-in-mtx-naive-early-rheumatoid-arthritis-patients-is-maintained-after-discontinuation-up-to-1-year/. Accessed December 4, 2015.
UCB receives positive EU CHMP opinion for CIMZIA® (certolizumab pegol) http://www.ucb.com/presscenter/News/article/UCB-receives-positive-EU-nbsp-CHMP-opinion-for-CIMZIA-certolizumab-pegol-to-treat-severe-active-and-progressive-rheumatoid-arthritis-in-DMARD-na-ve-patients