Lutikizumab Fails as Pain Treatment for Erosive Hand Osteoarthritis

June 20, 2019

Lutikizumab does not improve pain or imaging outcomes for patients with erosive hand osteoarthritis, according to new research.

Lutikizumab does not improve pain or imaging outcomes for patients with erosive hand osteoarthritis, according to new research.

In a study published in a recent issue of the Annals of Rheumatic Diseases, investigators determined that adequately blocking interleukin-1(IL-1) with the dual variable domain immunoglobulin lutikizumab is no more effective than a placebo.

“Despite adequate systemic lutikizumab pharmacodynamic effects, lutikizumab did not significantly improve clinical outcomes or imaging outcomes in patients with erosive hand osteoarthritis, compared to placebo,” said study author Margaret Kloppenburg, M.D., Ph.D., rheumatology professor at Leiden University Medical Center in The Netherlands, “suggesting that targeting IL-1 may be ineffective for the treatment of erosive hand osteoarthritis.”

To determine the efficacy, safety, pharmacokinetics, and pharmacodynamics of lutikizumab, researchers randomized 132 study participants to receive either 200 mg of lutikizumab subcutaneously every two weeks for 24 weeks or a placebo. Blood samples were taken at baseline and 26 weeks to determine lutikizumab levels and anti drug antibody responses to the medication.

Based on the blood analysis, patients receiving lutikizumab experienced significant reductions in serum IL-1alpha and IL-1beta levels, as well as significantly drops in neurotrophils, proteins indicating liver inflammation, markers of synovitis. These patients also saw significant mean reductions in platelet counties, white blood cell counts, and alkaline phosphatase, as well as increases in high-density lipoprotein cholesterol. Placebo patients did not see the same changes.

But, according to study results, the number of tender and swollen joints at 26 weeks was similar between placebo and lutikizumab, as were other outcomes, including pain, stiffness, and grip strength. Imaging also showed similar radiographic evidence of erosive joints between both groups. Equivalent proportions of participants in both groups experienced adverse events, pointing to similar safety profiles, as well.

Additionally, the lutikizumab and placebo groups saw similar amounts of rescue medication use.

Consequently, investigators said, targeting IL-1 may not be a good clinical option for treatment erosive hand osteoarthritis.

REFERENCE

Kloppenburg M, Peterfy C, Haugen I, et al. "Phase IIa, placebo-controlled, randomized study of lutikizumab, an anti-interleukin-1alpha and anti-interleukin-1beta dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis."Annals of Rheumatic Diseases (2019), doi: 10.1136/annrheumdis-2018-213336.