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Emerging Medications for Treating Uveitis and Inflammation in Ankylosing Spondylitis

January 14, 2021
Tumor necrosis factor inhibitor and monoclonal antibody show promise for reducing uveitis pain.

A PPM Brief

UCB, a biopharmaceutical company specializing in neurology and immunology, recently presented data from two ongoing clinical trials. The data were based on studies of certolizumab pegol and the experimental drug bimekizumab. Here, a quick review.

 

Certolizumab Pegol for Acute Anterior Uveitis in Ankylosing Spondylitis

Certolizumab pegol (Cimzia) is an TNF inhibitor indicated for the treatment of adults with ankylosing spondylitis (AS) and other inflammatory diseases, including Crohn’s and psoriatic arthritis. FDA approved the drug in 2019. More recently, however, it has been found that when certolizumab pegol is given by subcutaneous injection, it may reduce acute anterior uveitis (AAU) in patients with AS. Uveitis is relatively common in rheumatic disease but especially common in AS, with an estimated incidence of 33%.1

Uveitis – particularly when associated with Ankylosing Spondylitis – can cause and pain and inflammation in the eye.

Uveitis – particularly the kind associated with AS – can place a lot of wear and tear, so to speak, on the eye, explains Alan Palestine, MD, professor of ophthalmology and chief of the Uveitis and Ocular Immunology Section at the University of Colorado. “Each episode is painful for the patient but not particularly damaging to the eye. However, most patients have multiple episodes, so those cumulative events over years can do a lot of damage,” he says.

Treatment typically includes steroid drops however, in some cases, oral steroids or even steroid injections around the eye are required, and these can cause long-term damage themselves, says Dr. Palestine. “Using steroids in the eye increases the risk of cataract formation and the risk of glaucoma.” He adds that “recurrent inflammation also causes cataracts and glaucoma, as well as other damage to the eye.”

The data – presented at ACR's 2020 Virtual Convergence – offers support for a better treatment option for AS patients who suffer from AAU. Post-marketing trial data from the first 48 weeks of a 96-week open-label study included 85 participants.2 As compared to the 48 weeks prior to treatment, the percentage of patients who experienced one AAU flare (64%) or two or more AAU flares (31.5%) during the 48-weeks of treatment was reduced to 12.4% in the former group and 2.2% in the latter group.

Dr. Palestine says this is a breakthrough clinicians have been seeking. “We’ve known [anti-TNF drugs were effective for AAU] for a long time, but there’s never been a study like this – a prospective trial – done looking at an anti-TNF drug’s effect on uveitis.”

In addition to the effects on AAU, overall disease activity in AS patients was reduced as well. According to the Bath Ankylosing Spondylitis Disease Activity Score (ASDAS), 31.4% of patients in the study achieved partial remission and 29.1% saw a major improvement in disease activity.

Certolizumab pegol has also been shown to be an effective treatment for non-radiographic axial spondyloarthritis (nr-axSpA), according to further data presented in a poster at the ACR 2020 meeting. The 3-year, Phase 3, 52-week, double-blind, placebo-controlled study found that of 317 participants with a diagnosis of active nr-axSpA, the 159 patients who had taken certolizumab pegol for one year experienced major reductions in symptoms as compared to 158 subjects assigned to a placebo group.3

Efficacy was determined by ASDAS scores. “Major improvement,” was defined as ASDAS decrease from a baseline of greater than or equal to two points or reaching the lowest possible value on the scale. At Week 52, major improvement status was shown in 47.2% of the certolizumab pegol group as compared to 7% in the placebo group.

 

Bimekizumab and Ankylosing Spondylitis Inflammation

UCB researchers also presented clinical data on bimekizumab, the company’s investigational antibody therapy. 4 Bimekizumab is an mAb that selectively inhibitsIL-17A and IL-17F. Results were based on the Phase 2 BE AGILE trial investigating the use of bimekizumab for the treatment of AS, specifically to reduce inflammation.

The trial consisted of a 12-week period in which variable doses (160 mg or 320 mg every 4 weeks) were given before patients were randomized to one of three doses for another 36-week period. Patients who completed 48-week treatment were eligible to join an extension study. In the extension study, all participants were given the lower dose (160 mg every 4 weeks) no matter which dosing regimen they had been on in the earlier part of the study. Outcome measures were disease activity scores, pain assessment, and inflammation.

At Week 96, efficacy was assessed for 238 participants. Responses were similar for the two groups at 48 weeks and again at 96 weeks. Rapid improvements, as assessed by the ASDAS and the BASMI (the Bath Ankylosing Spondylitis Metrology Index) and the BASFI (Bath Ankylosing Spondylitis Functional Index) were noted at Week 12, and further improvements were noted from Weeks 48 to 96 (in the extension trial). The researchers concluded that reducing the dose from 320 mg to 160 mg did not reduce the effectiveness of the therapy. They also stated that they found no unexpected safety issues compared with previous studies.

Last updated on: January 15, 2021
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