Clazakizumab for psoriatic arhtritis phase2b study

[Fred]

This study was To evaluate the efficacy of clazakizumab an interleukin (IL)-6 blocker in patients with psoriatic arthritis.

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Objective:
To evaluate the efficacy of clazakizumab, a monoclonal antibody with high affinity and specificity for the interleukin (IL)-6 cytokine, in psoriatic arthritis (PsA).

Methods:
In this randomized, double-blind, placebo-controlled, dose-ranging study (NCT01490450), patients with active PsA and an inadequate response to non-steroidal anti-inflammatory drugs were randomized (1:1:1:1) to subcutaneous placebo or clazakizumab 25 mg, 100 mg, or 200 mg every 4 weeks, ± methotrexate. The primary endpoint was American College of Rheumatology (ACR) 20 response rate at week 16, with secondary efficacy endpoints at weeks 16 and 24.

Results:
A total of 165 patients were randomized. At week 16, ACR20 response was significantly higher with clazakizumab 100 mg versus placebo (52.4% vs 29.3%; P=0.039). ACR20 responses at week 16 were 46.3% with clazakizumab 25 mg (P=0.101 vs placebo) and 39.0% with clazakizumab 200 mg (P=0.178 vs placebo). ACR50/ACR70 response rates were numerically higher with clazakizumab versus placebo at weeks 16 and 24. Compared with placebo, clazakizumab treatment significantly improved musculoskeletal manifestations (joint signs and symptoms, enthesitis, and dactylitis), with minimal improvements in skin, without clear evidence of a dose response. Clazakizumab was well tolerated.

Conclusions:
This is the first clinical trial of an IL-6-targeted therapy in PsA. Clazakizumab may be an effective treatment option for musculoskeletal aspects of PsA, but further studies are required to confirm the appropriate dose due to the lack of dose response in this study. The safety profile was consistent with the pharmacology of IL-6 blockade and prior clinical experience with this antibody in rheumatoid arthritis.

This article is protected by copyright. All rights reserved.

Source: onlinelibrary.wiley.com

*Early view funding unknown.

[jiml]

Another good possibility for the future for PsA sufferers it's good to see this approach to the problem

I'm not sure what is meant by lack of dose response

Let's hope it will spark further studies