Thursday, 17 Oct 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

Myositis Patients at High Risk of Opportunistic Infections

Among patients with systemic rheumatic diseases, the highest incidence of opportunistic infections was seen in those with polymyositis/dermatomyositis (PM/DM), Taiwanese researchers found.

Warfarin Superior to Xarelto in Antiphospholipid Syndrome

A 3 year, multicenter, European, study shows that rivaroxaban was inferior to warfarin in preventing thrombosis in patients with antiphospholipid syndrome (APS) according to the Annals of Internal Medicine. Thus despite the inconvenience of warfarin, it remains the best option for patients with APS.

Declining Trends in Antineutrophil Cytoplasmic Autoantibody–Associated Vasculitis Mortality in the USA

Annals of Internal Medicine reports that age-adjusted mortality rates for antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) have improved over time - with a decline of nearly 2 percent per year in the United States from 1999 to 2017. Nevertheless, long-term outcomes continue to lag behind mortality rates of the general population.

Serum Interferon Predicts Lupus Flares

Elevated serum levels of interferon-α among patients whose systemic lupus erythematosus (SLE) was in remission helped predict future disease flares, European researchers found.

Among 254 SLE patients who were in remission, 26% had abnormally high serum levels of interferon-α at baseline, according to Alexis Mathian, MD, of Pitié-Salpêtrière Hospital in Paris, and colleagues.

ILD Patients At Risk for Autoimmune Disease

Patients diagnosed with interstitial pneumonia with autoimmune features (IPAF) are at an increased risk of developing a systemic autoimmune rheumatic disease (ARD).

A retrospective study of interstitial lung disease (ILD) patients from the Columbia University Irving Medical Center (2009 to 2017) looked for those who did or did not meet IPAF criteria.