Promising New Clinical Trial Results For TNFi-Resistant Ankylosing Spondylitis

By Spondylitis Association of America

Monday, November 19, 2018

A new phase 3 clinical trial tested the efficacy and safety of the IL-17 inhibitor ixekizumab (brand name Taltz) in a population of ankylosing spondylitis (AS) patients who did not improve with TNF inhibitor (TNFi) treatment. Studies report that roughly 30 percent of those with AS don’t see enough improvement with their TNFi medications to continue treatment.

Using a double-blind experiment method of randomized placement, in which neither the tester nor the patient know who is receiving which treatment, 316 AS patients with a previous negative response to TNFi medications were placed in three groups. In the first group (referred to as IXEQ2W) the active medication was administered every two weeks; in the second group (referred to as XEQ4W) the active medication was administered every four weeks; and third group (Placebo) received an inactive substance. 

By the 16th week 30.6 percent of patients in the IXEQ2W group (those receiving the medication every two weeks) demonstrated significant improvements in AS signs and symptoms. In comparison, 25.4 percent of patients in the IXEQ4W group (receiving the medication every four weeks) achieved significant improvements in 16 weeks, along with 12.5 percent of those in the placebo group. One death was reported, in the IXEQ2W group.

The lead author on this study, Dr. Atul Deodhar, who is also a long-standing member of SAA’s Medical and Scientific Advisory Board, finds hope in this study. "Many people with this chronic, debilitating disease are still searching for an effective treatment. These positive results provide support for ixekizumab as a potential treatment option for patients with AS, including those who have had an inadequate response to treatment with TNF inhibitors, a difficult-to-treat population," said Dr. Deodhar in news release summarizing this study.

Note: Ixekizumab is not currently FDA approved for use in ankylosing spondylitis. It was approved in 2017 for use in psoriatic arthritis.

**Further information regarding the different types of biologic treatments (TNF Inhibitors, IL-17 Inhibitor, IL 12/23 Inhibitor) can be found at the following link. https://www.spondylitis.org/Medications#1998

**Full research study article: https://doi.org/10.1002/art.40753

References:

EurekAlert. (2018, October 10). Immune therapy generates promising results in hard-to    treat ankylosing spondylitis. Retrieved October 10, 2018, from https://www.eurekalert.org/pub_releases/2018-10/w-itg101818.php

Deodhar, A., Poddubnyy, D., PachecoTena, C., Salvarani, C., Lespessailles, E., Rahman, P., . . . Reveille, J. D. (2018, October 20). Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: 16 Week Results of a Phase 3 Randomized, DoubleBlind, Placebo Controlled Trial in Patients with Prior Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors. Retrieved from https://onlinelibrary.wiley.com/doi/abs/10.1002/art.40753

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