AS Patients on Taltz Treatment Experienced Less Fatigue and Pain, and Better Sleep Over 1 Year, Phase 3 Trials Show

Treatment with Taltz (ixekizumab) reduces fatigue and pain in people with ankylosing spondylitis (AS) for up to one year, results from two Phase 3 trials show.

The data were discussed at the 2019 American College of Rheumatology/Association for Rheumatology Professionals Annual Meeting in a presentation, titled “Ixekizumab Improves Fatigue, Pain, and Sleep up to 52 Weeks in Patients with Radiographic Axial Spondyloarthritis.”

Eli Lilly‘s Taltz is a modified antibody that blocks the activity of interleukin-17A, an inflammatory molecule that has been implicated in AS progression. It is administered via subcutaneous (under-the-skin) injection and belongs to a class of therapies known as biologic disease-modifying antirheumatic drugs (bDMARDs).

The COAST-V (NCT02696785) trial tested Taltz in people with AS who had never been treated with a bDMARD, and the COAST-W (NCT02696798) trial tested it on patients who had failed treatment with a TNF inhibitor (TNFi).

In the trials, both funded by Eli Lilly, participants were randomly assigned to treatment with Taltz (80 mg every two or four weeks) or a placebo. In COAST-V, a subgroup of participants received treatment with the TNFi Humira (adalimumab, by AbbVie).

Previously reported results at 16 weeks of treatment demonstrated significant improvements in sleep and quality of life, as well as reductions in pain and fatigue.

After this timepoint (and following a six-week wash-out period for those on Humira), participants continued on or were switched to Taltz until week 52 (one year).

Updated findings from the two studies indicate that the benefits of Taltz were sustained long-term. Fatigue — rated between 0 (no fatigue) and 10 (worst possible pain) on the Fatigue Numeric Rating Scale — was reduced significantly with Taltz, from a mean score of about 7 at baseline to nearly 2.5 after 52 weeks.

Similar benefits were seen in measurements of spinal pain, sleep quality, and patient-reported disease activity.

“Fatigue, spinal pain, and sleep improved with [Taltz] treatment over 52 weeks in both biologic-naïve and TNFi-experienced patients with [AS],” the researchers wrote.

Notably, participants on Taltz after prior treatment with Humira or a placebo also showed substantial benefits across all evaluated measures.

The data also showed that treatment with Taltz reduced fatigue as early as week 8 and eased spinal pain from week 1, compared with the placebo.