Thursday, 24 Aug 2017

You are here

Ixekizumab Effective in TNF Failure Psoriatic Arthritis - SPIRIT-P2 Trial

Ixekizumab (Taltz) is currently approved for use in plaque psoriasis and is being developed for use in psoriatic arthritis (PsA). New results show IXE to be highly effective at skin and joint outcomes in PsA patients who have failed a TNF inhibitor (TNFi).

Previously, the SPIRT I trial demonstrated efficacy and safety of ixekizumab (IXE) in patients who were biologic DMARD-naive. In that 52-week study, 417 active PsA patients received either IXE 80 mg, IXE 40mg, adalumumab or placebo.  IXE patients showed significant improvement of arthritis, dactylitis and enthesitis along with impressive PASI 75 and PASI 90 results as well.

The current SPIRIT P2 trial assessed the efficacy of IXE in patient not responding to TNFi.  In this phase 3 trial, 363 adults with psoriatic arthritis were assigned (1:1:1) subcutaneous IXE 80 mg every 4 weeks or IXE every 2 weeks after a 160 mg starting dose or placebo. The primary endpoint was ACR-20 response at week 24.

At week 24, ACR-20 responses were higher with with IXE every 4 weeks (53%) and IXE every 2 weeks (48%) compared to placebo (20%).

Serious adverse events were low (3% IXE q4wk; 7% IXE q2wk; 3% placebo) and there were no deaths. Three (2%) serious infections, were seen in the IXE 2 weeks group.

Both the 2-week and 4-week ixekizumab dosing regimens improved the signs and symptoms of patients with active psoriatic arthritis and who had previously inadequate response to tumour necrosis factor inhibitors, with a safety profile consistent with previous studies investigating ixekizumab.

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

Add new comment

More Like This

IV Golimumab Shines in Psoriatic Arthritis

Golimumab (GOL) is one of five marketed TNF inhibitors (TNFi) that is FDA approved for use in psoriatic arthritis (PsA). PsA approval was based on a 259 patient, randomized, controlled trial wherein GOL treated patients exhibited at week 24 ACR20/50/70 response of 52%, 32%, and 19%, respectively.

Therapeutic Update: 5 Questions on FDA Hearing for Tofacitinib in PsA

In this Therapeutic Update, Drs. Cush and Gibofsky answer five questions regarding the August 3rd FDA Arthritis Advisory Committee meeting that reviewed the potential approval of tofacitinib (Xeljanz) in patients with active psoriatic arthritis. The panel was nearly unanimous (10-1) in favor of the efficacy and safety profile of of tofacitinib, and similarly voted 10-1 to approve this drug for use in PsA. Final decisions on these recommendations from the AAC panel will be made at a later date by the FDA. 

Psoriatic Arthritis Patients with Comorbidities have Worse Disease and Poor Responses

A population-based cohort study shows that comorbidities in psoriatic arthritis patients (PsA) were associated with higher disease activity, shorter persistence and reduced clinical response to TNF inhibitors (TNFi). 

FDA Arthritis Advisory Panel Endorses Tofacitinib Approval for Psoriatic Arthritis

On Thursday, August 3, the FDA Arthritis Advisory Committee (AAC) met to consider tofacitinib for use in patients with psoriatic arthritis. The panel voted 10-1 in favor of approval.

Pediatric Consensus on Comorbidity Assessments

Comorbidity is a serious consequence or confounder in patients with inflammatory diseases. This has been well described in both psoriatic and rheumatoid disease.  JAMA Dermatology has published the recommendations of a pediatric multispecialty group regarding the screening for comorbid disease. (Citation source https://buff.ly/2u4pi3J)