Clinical Trial Data Show Durable Efficacy of Cimzia, Bimekizumab

Treatment with Cimzia (certolizumab pegol) can ease eye inflammation in people with ankylosing spondylitis (AS), and reduce symptoms in those with active non-radiographic axial spondyloarthritis (nr-axSpA), new clinical trial data show.

The data were presented by researchers from UCB — which markets Cimzia — and other institutions at the annual meeting of the American College of Rheumatology. New data on the experimental therapy bimekizumab were also presented at the meeting, along with evidence of consistent benefits of both therapies in people with psoriatic arthritis (PsA).

“The data demonstrate the real-world difference that CIMZIA can make for axSpA and PsA patients by providing major improvements in disease activity,” Emmanuel Caeymaex, executive vice president of immunology solutions and head of U.S. at UCB, said in a press release.

Cimzia works by blocking the activity of tumor necrosis factor alpha, a signaling molecule that drives inflammation. The therapy has been widely approved for AS, nr-axSpA, and other inflammatory diseases.

The Phase 4 clinical trial C-VIEW (NCT03020992) tested Cimzia’s effect on acute anterior uveitis — a kind of eye inflammation that can cause symptoms such as blurred vision and pain — in people with AS. Uveitis is the most common non-joint-related symptom in people with AS.

During the trial, participants experienced significantly fewer instances of uveitis, according to researchers who reported data from the first 48 weeks of treatment in their presentation, “Reduction of Anterior Uveitis Flares in Patients with Axial Spondyloarthritis Following 1 Year of Treatment with Certolizumab Pegol: 48-Week Interim Results from a 96-Week Open-Label Study.”  In total, 85 people reached this time point.

Compared to before the study, the number of participants experiencing one flare was lower (12.4% vs. 64%), as was the number of those experiencing two or more flares (2.2% vs. 31.5%). In addition, among the 13 participants who had flares both before and during the trial, the mean duration of flares was reduced from 97.4 to 58.4 days.

The findings also showed that Cimzia treatment eased AS symptoms, with 31.4% of participants reaching partial disease remission according to the Assessment of SpondyloArthritis international Society (ASAS).

In the Phase 3 clinical trial C-axSpAnd (NCT02552212), which included 317 people with active nr-axSpA, more participants given Cimzia for a year reported major reductions in symptoms, compared with those on placebo. Scientists presented these findings in a new analysis of data in their presentation, “Certolizumab Pegol Efficacy in Patients with Non-Radiographic Axial Spondyloarthritis Stratified by Baseline MRI and C-Reactive Protein Status.”

nr-axSpA is characterized by AS-like symptoms, but without evidence of joint damage visible on an X-ray. Active nr-axSpA was defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score above 4 and spinal pain higher than 4 on a 10-point scale.

The investigators also assessed inflammation visible on an MRI and/or by elevated levels of C-reactive protein. They looked at response to treatment in three groups in C-axSpAnd: those with inflammation on MRI but not high CRP levels, those with high CRP levels but no inflammation on MRI, and those with both. In all three groups, significantly more participants given Cimzia reported major reductions in symptoms compared to a placebo. The largest treatment responses were seen in those with both high CRP levels and inflammation on MRI.

Researchers also presented new clinical data on bimekizumab, UCB’s investigational antibody therapy intended to block the inflammatory signaling molecules IL-17A and IL-17F. Results from the Phase 2b clinical trial BE AGILE (NCT02963506), reported previously, demonstrated that this potential treatment could ease AS symptoms at 48 weeks of treatment.

Participants who completed the 48-week trial were allowed to enroll in an extension study (NCT03355573).

The researchers presented data for 238 participants who completed up to 96 weeks (just under two years) of total treatment in these trials in the session: “Bimekizumab Long-Term Efficacy and Safety over 96 Weeks in Patients with Ankylosing Spondylitis: Interim Results from a Phase 2b Open-Label Extension Study.”

Results showed that responses to treatment seen at 48 weeks — with measures such as BASDAI and ASAS — were largely maintained at 96 weeks, and no new safety concerns were identified.

As such, bimekizumab “provides further sustained long-term improvements in key efficacy outcome measures,” the researchers concluded.

Notably, participants included in the efficacy analysis of BE-AGILE were given one of two doses of the investigational therapy (160 or 320 mg), while in the extension study, all participants were given the lower dose. Responses were similar in the two dose groups at 48 weeks; at 96 weeks, responses were again similar in those who continued on the lower dose compared to patients who switched from the higher dose.

“Our bimekizumab data further support the selective inhibition of IL-17F in addition to IL-17A in AS and PsA, showing that bimekizumab has the potential to provide durable clinical responses impacting overall quality of life,” said Caeymaex.