Friday, 23 Aug 2019

You are here

Abatacept Disappoints in Systemic Sclerosis

A 12‐month, Phase 2 trial has shown that subcutaneous abatacept was well tolerated in patients with diffuse cutaneous systemic sclerosis (dcSSc), but failed to significantly change the skin outcomes as measured by the change in modified Rodnan skin score (mRSS)

A total of 169 dsSSc patients were screened and 88 patients were randomized in a double‐blind, placebo‐controlled protocol to receive either abatacept 125 mg subcutaneous or matching placebo; patients were stratified by duration of dcSSc. The co‐primary end points were change in (mRSS) and safety over 12 months.

At entry the mean mRSS was 22.45; by the end of 12 months, the adjusted mean change in mRSS at 12 months was ‐6.24 units in the abatacept and ‐4.49 units in the placebo (p=0.28).  Decline in mRSS over 12 months was clinically and significantly higher in abatacept vs. placebo for the Inflammatory (p<0.001) and Normal‐like skin gene expression subsets (p=0.03).

While there was less decline in FVC in abatacept pts, these results were not significant (-36.39 ABA vs. -121.6 PBO; p=0.19). Only the ACR CRISS score favored ABA over PBO.  Two other secondary outcome measures (HAQ‐DI and a composite measure) were clinically and statistically significant favoring abatacept. 

Thirty-four (77%) and 35 (80%) completed the 12-month trial in the abatacept and placebo groups, respectively. At 12 months, 7 (16%) and 16 (36%) in the abatacept and placebo groups, respectively, had received escape therapy for worsening dcSSc

These preliminary phase II results suggest that T cell targeting with abatacept may not be an effective long term intervention in dcSSc patients. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

With Autoimmunity, Checkpoint Inhibitors Can Be Used

Among patients with pre-existing autoimmune diseases who developed cancer and were treated with immune checkpoint inhibitors (ICI), flares of the underlying disease and other immune-related adverse events were common, a retrospective study conducted in France showed.

New EULAR/ACR Classification Criteria for SLE

The European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) have jointly developed new classification criteria for systemic lupus erythematosus (SLE); prompted by the need for criteria that were both highly sensitive and specific. The net result is improved sensitivity and specificity, but the use of positive ANA requirement along with a longer list of weighted criteria ensures its utility in SLE research (including early or latent SLE), but not clinical practice.

Sjogren's Syndrome at Risk for Psychiatric Disorders

A population-based claims study from Taiwan shows significantly increased incidences of depressive disorder, anxiety disorder, and sleep disorder in patients with primary Sjögren’s syndrome (pSS). 

FDA AAC Splits Vote in Favor of Nintedanib for Scleroderma Interstitial Lung Disease

The FDA convened Arthritis Advisory Committee to consider nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) and voted 10-7 in favor of approving the drug for this new indication.

FDA Approves Apremilast for Behcet's Oral Ulcers

The US Food and Drug Administration (FDA) has approved apremilast (Otezla) for the treatment of oral ulcers associated with Behçet’s Disease, a rare chronic multisystem inflammatory disease that affects about 5 in 100,000 persons in the USA.