Breaking News: FDA Approves Certolizumab Pegol, (CIMZIA®) For Non-Radiographic Axial Spondyloarthritis, Making It The First Biologic Available To Those Living With Nr-axSpA.

By Spondylitis Association of America

Friday, March 29, 2019

On March 28, 2019, the U.S. FDA announced the approval of the TNF inhibitor, certolizumab pegol (CIMZIA®) for the treatment for non-radiographic axial spondyloarthritis (nr-axSpA.) This is the first, and currently only biologic agent to gain approval for nr-axSpA in the U.S., providing those living with the condition access to a new class of medication.

Nr-axSpA is a form of axial (spinal) spondyloarthritis, where the characteristic changes in the spine are not seen on X-ray, however pain, stiffness, and other clinical symptoms occur, contributing to a high disease burden with limited medication options available. In contrast, in radiographic axSpA (or ankylosing spondylitis) changes and structural damage can be observed on X-ray. Up to now, those with the non-radiographic version of this condition lacked access to any biologic medication, and successful treatment of active disease with other available medications was not generally achieved. As such, the FDA approval of certolizumab pegol for nr-axSpA fills an unmet need, and is a big step for those living with the condition. (The biologic had previously gained approval for active ankylosing spondylitis.)

The recent nr-axSpA approval is based on promising results from the C-axSpAnd study: a 52-week long, Phase 3 clinical trial of certolizumab pegol for adults with non-radiographic axial spondyloarthritis.

The study included 317 international participants with adult-onset nr-axSpA, with a minimum of 12 months of active disease, a high level of inflammation despite receiving NSAID medications, and a high level of clinical symptoms. A double-blind study was conducted, in which neither the participants nor the researchers know who is receiving the study medication, and who is in the inactive, placebo control group. Among the 317 participants, 159 were randomly selected to receive certolizumab pegol, with the other 158 participants receiving an inactive substance (sugar pill.) All study participants, in addition, received non-biologic background medication [NBBM.] Those in the treatment group were administered 400 mg of certolizumab pegol at weeks 0, 2 and 4, and then 200 mg every 2 weeks after that.

The Ankylosing Spondylitis Disease Activity Score (ASDAS) metric was used to assess disease activity in the participants. To do so, scores are analyzed collectively using the following five measures: patients’ self-reported back pain; peripheral pain/swelling in joints; duration of morning stiffness; Patients’ Global Assessment of Disease Activity (PGADA) score; and CRP levels (inflammatory markers found in the blood.)

By week 52, nearly half (47.2%) of the treatment group showed marked improvements in response to the study medication, compared to 7.0% of the placebo control group.

The study design allowed all participants to switch to an open label certolizumab pegol, or choose another biologic and background medication to use, at any point during the study. However, it was highly discouraged during the first 12 weeks of the study.  

At 52 weeks, 60.8% of the placebo group participants had selected to switch to the open label biologic treatment, compared to 12.6% in the certolizumab pegol treatment group.

According to the study’s findings, the authors conclude, the majority of those with active nr-axSpA despite treatment with NSAIDs do not have their condition improve without further medical intervention, and treatment with certolizumab pegol results in significant improvement in clinical symptoms of the disease in this population.

***Dr. Atul Deodhar and Dr. Lianne Gensler, members of SAA’s Medical and Scientific Board, were contributing authors on this study.


A 52‐Week Randomized Placebo‐Controlled Trial of Certolizumab Pegol in Non‐Radiographic Axial Spondyloarthritis

Deodhar, A. , Gensler, L. S., Kay, J. , Maksymowych, W. P., Haroon, N. , Landewé, R. , Rudwaleit, M. , Hall, S. , Bauer, L. , Hoepken, B. , de Peyrecave, N. , Kilgallen, B. and van der Heijde, D. (2019), A 52‐Week Randomized Placebo‐Controlled Trial of Certolizumab Pegol in Non‐Radiographic Axial Spondyloarthritis. Arthritis Rheumatol. Accepted Author Manuscript. doi:10.1002/art.40866

Full article available here.

Certolizumab pegol superior to placebo in non-radiographic axial SpA

Deodhar A, E. A. (2019, March 19). Certolizumab pegol superior to placebo in non-radiographic axial SpA. Retrieved March 26, 2019, from{e669eb33-3c90-42a6-aaea-006ad7b95cb2}/certolizumab-pegol-superior-to-placebo-in-non-radiographic-axial-spa


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