Tuesday, 20 Nov 2018

You are here

Ixekizumab (Taltz) FDA Approved for Psoriatic Arthritis

On Friday, December 1st, the FDA approved Lilly's drug Taltz (ixekizumab) for use in adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 

Christi Shaw, president, Lilly Bio-Medicines. estimates that PsA affects 1.6 million Americans. Taltz, an IL-17 inhibitor, has previously been approved for plaque psoriasis where it has shown high level PASI75 and PASI100 responses.

The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg every 4 weeks. For those psoriatic arthritis patients with coexistent moderate-to-severe plaque psoriasis, the dosing regimen for plaque psoriasis is 160 mg (two 80 mg injections) at Week 0, followed by 80 mg at Weeks 2, 4, 6, 8, 10, and 12, then 80 mg every 4 weeks.

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

Product label warnings include the usual low level risk of infection, the need for TB screening and the unique risk of colitis or colitis exacerbation - few cases of Crohn's disease (0.1%) and ulcerative colitis (0.2%) were seen in Taltz treated patient but not placebo controls.  Other common, nonserious side effects include njection site reactions, upper respiratory tract infections, nausea, and tinea infections. Necessary vaccines should be given prior to ixekizumab initiation and live virus vaccines should be avoided. 

The efficacy and safety of Taltz was determined from findings from two randomized, double-blind, placebo-controlled phase 3 studies – SPIRIT-P1 and SPIRIT-P2 – which included more than 670 adult patients with active PsA. SPIRIT-P1 was done in biologic naive PsA patients and SPIRIT-P2 included patients with prior use of a tumor necrosis factor inhibitor (TNFi). Compared to placebo, the ACR20 response rates was 58% in SPIRIT-P1 (30% PBO) and 53% in SPIRIT-P2 (20% PBO).

"For patients with PsA, treatment goals often include improvement in joint symptoms," said Philip Mease, M.D., Swedish Medical Center and University of Washington. "Based on the study results, Taltz can provide significant improvement in joint symptoms for patients who had never been treated with a biologic disease-modifying antirheumatic drug as well as patients who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors." 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Ixekizumab COAST-V Trial Wins in Axial Spondyloarthritis

Lancet has published the results of a study showing that ixekizumab (an IL-17A inhibitor) yielded significant clinical benefit and radiographic protection when given to NSAID treated patients with radiographic axial spondyloarthritis (AxSpA).

Doubling Down on IL-17 In Psoriatic Arthritis

The monoclonal antibody bimekizumab, which neutralizes both interleukin (IL)-17A and 17F, was effective for both musculoskeletal and skin outcomes in psoriatic arthritis (PsA) in a phase IIb study.

Updates on Psoriatic Arthritis at ACR 2018

I think 2018 was the year that belonged to psoriatic arthritis (although some may argue in favor of immune conditions induced by Checkpoint inhibitors). Many years ago the late Professor Verna Wright in Leeds (UK) was a lone voice for many years describing the clinical subtypes of Psoriatic arthritis as something distinctive from rheumatoid arthritis. For a long time we thought that the treatments for PsA were just the same as RA since we were treating the same problem of synovitis.

Axial Spondylitis Abstracts Roundup

There have been a number of interesting posters and presentations covering the field of axial spondyloarthropathy. I’ve picked out a few points that I found particularly relevant.

Classification Criteria

NK cells and a Potential Role in the Development of PsA vs PsC (Cutaneous Psoriasis)

Human NK cells express multiple receptors that interact with HLA class I molecules which, in turn, suppy peptides that bind HLA-E to form CD94/NKG2A NK receptor ligands. These peptides correspond to -22 to -14 residues in the leader sequences of HLA-A, HLA-B and HLA-C binding to the HLA-E site. Methionine – 21 delivers functional peptides in stark contrast to threonine – 21 which does not.