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.
References:
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
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