Lutikizumab does not significantly improve pain or imaging outcomes in hand osteoarthritis

Published On 2019-06-23 13:40 GMT   |   Update On 2019-06-23 13:40 GMT

DELHI: Interleukin-1α (IL-1α) and IL-1β are potential mediators of synovitis, cartilage damage, and bone loss in patients with erosive hand osteoarthritis (HOA). Lutikizumab is an immunoglobulin that binds and adequately blocks both IL-1α and IL-1β. Now, a recent study has found that despite adequate neutralization of IL-1α and IL-1β, treatment with lutikizumab, versus placebo, did not result in significantly better improvements in hand joint pain or imaging outcomes in hand osteoarthritis.



Results of a phase 2a, randomised, double-blind study, published in the BMJ Journal Annals of the Rheumatic Diseases, found that treatment with lutikizumab resulted in more frequent injection site reactions, neutropenia, and discontinuations compared to placebo.

Hand osteoarthritis is a common musculoskeletal disease, with prevalence rising steeply with increasing age. The disease is associated with hand pain, stiffness, functional limitation, decreased grip strength and reduced quality of life.


Margreet Kloppenburg, Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands, and colleagues conducted the study to assess the safety and efficacy of Lutikizumab for the treatment of erosive hand osteoarthritis.


“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 Dr Kloppenburg, “suggesting that targeting IL-1 may be ineffective for the treatment of erosive hand osteoarthritis.”


For the study, the 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.

The primary endpoint was a change in Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain subdomain score from baseline to 16 weeks.


Also Read: Avoid DMARDs in hand osteoarthritis patients, recommends Updated EULAR guidelines

Key findings of the study include:




  • Of 132 randomised subjects, 1 received no study drug and 110 completed the study (placebo, 61/67 (91%); lutikizumab, 49/64 (77%)).

  • Based on the blood analysis, patients receiving lutikizumab experienced significant reductions in serum IL-1alpha and IL-1beta levels, as well as significant drops in neutrophils, 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.

  • 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.

  • The lutikizumab and placebo groups saw similar amounts of rescue medication use.


Also Read: Management of Hand Osteoarthritis : EULAR 2018 Recommendations

" Targeting IL-1 may not be a good clinical option for treatment erosive hand osteoarthritis, suggested the authors.

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