Survey Finds Cimzia Prescriptions for nr-axSpA on the Rise in US
After its approval last year, Cimzia (certolizumab pegol) may now be the most prescribed therapy in the U.S. for people with non-radiographic axial spondyloarthritis (nr-axSpA), according to an online survey of 98 rheumatologists.
Cimzia is the only therapy currently approved in the U.S. for the treatment of nr-axSpA. Most of the rheumatologists surveyed reported prescribing the biologic therapy to at least one patient over the past six months, accounting for the highest percentage among on- and off-label biologics and small molecules in this patient population. (Off-label means a therapy is being used for an indication other than those for which it is currently approved.)
Axial spondyloarthritis (AS) is a type of arthritis that mainly affects the joints of the spine, causing chronic back pain. The disease takes the name of ankylosing spondylitis if joint damage is visible through radiographs (X-rays) or nr-axSpA when no such changes can be seen with this approach.
Cimzia, developed by Belgium-based UCB, is an artificial antibody fragment designed to block the activity of tumor necrosis factor alpha, or TNF-alpha, a molecule that acts as a potent driver of inflammation.
Therapeutic options for people diagnosed with nr-axSpA are still more limited than those with AS. According to the survey findings and in agreement with previous reports, people with nr-axSpA are less likely to receive treatment with biologics or small molecules than those with AS.
After becoming available in the U.S., Cimzia was also approved in Canada for people with nr-SpA. For those with AS, the medication has been available since 2013.
In contrast, nr-SpA patients in the European Union can be treated with other TNF-alpha inhibitors, such as AbbVie‘s Humira (adalimumab) and Amgen‘s Enbrel (etanercept).
According to Spherix Global Insights‘ survey, which was conducted in March, the main barriers to prescribing Cimzia for nr-axSpA in the U.S. were insurance and cost issues. However, the number of rheumatologists citing these as obstacles has significantly decreased year after year, which highlights the potential widespread use for Cimzia.
The reported clinical benefits of Cimzia in nr-axSpA are likely contributors to its growing use in AS patients as well, despite few changes in recent years.
Besides TNF inhibitors, people with AS may also be treated with Novartis‘ Cosentyx (secukinumab) and Eli Lilly‘s Taltz (ixekizumab), both engineered antibodies against the proinflammatory molecule interleukin-17A (IL-17A).
While TNF inhibitors are still the top choice for AS, Cosentyx and Taltz are challenging their dominance, the survey shows. Cosentyx was approved in Europe for people with AS in 2015, and for the same indication in the U.S., but it is not currently approved for patients with nr-axSpA.
Taltz was approved in the U.S in 2019 and more recently in Canada. Last month, the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency, issued a recommendation favoring the approval of Taltz for both AS and nr-axSpA.
IL-17 inhibitors are used off-label in nr-axSpA, but both Cosentyx and Taltz have shown benefits in Phase 3 clinical trials.
Cosentyx has been the IL-17 inhibitor of choice for AS, with rheumatologists citing habit and experience with the therapy as the reason for their preference. Taltz is typically prescribed due to its efficacy, which could potentially challenge Cosentyx’s dominance in AS.
In addition, while rheumatologists have difficulties in differentiating between these two IL-17 inhibitors, Cosentyx is associated with easier health insurance approvals and long-term safety, while Taltz was reported to have a better dosing schedule and better patient support programs.
Nearly 3 of 4 rheumatologists said the choice between the two will come down to which therapy gets approved in the U.S. first for nr-axSpA first and/or has better insurance coverage.
As for potential treatments for these conditions, Pfizer‘s Xeljanz (tofacitinib citrate) and AbbVie‘s Rinvoq (upadacitinib) — both inhibitors of the Janus kinase (JAK), an enzyme with an important role in the activation of inflammatory mediators — have shown positive results for AS and nr-axSpA.
In AS, Xeljanz led to clinically meaningful reductions in spinal and sacroiliac joint inflammation in approximately one-third of patients in a Phase 2 trial (NCT01786668). Rinvoq pills effectively eased symptoms in hard-to-treat AS patients taking part in the SELECT-Axis 1 Phase 2/3 study (NCT03178487).
These results support the potential of both therapies, approved for other rheumatological conditions, for people with AS and nr-axSpA.
Another leading candidate is bimekizumab, the rheumatologists said. Bimekizumab is an antibody developed by UCB that blocks the activity of IL-17A and IL-17F, also an inflammation driver in AS. Data from a Phase 2b trial (NCT02963506) showed that bimekizumab was safe and had sustained efficacy over 48 weeks in people with AS.