Friday, 15 Feb 2019

You are here

Ustekinumab May be Effective in Lupus

Ronald F van Vollenhoven and colleagues have reported in Lancet that ustekinumab (UST), an interleukin-12 and -23 inhibitor, when added to usual therapy in systemic lupus erythematosus (SLE) patients, was shown to be superior to placebo at improving clinical efficacy and laboratory parameters after 6 months of therapy.

The study was a double-blind, phase 2, randomised, controlled trial of UST vs. PBO in ANA positive, adult SLE patients with moderate-to-severe disease activity.

Patients were randomly assigned (3:2) to the UST or PBO and were stratified according to skin biopsy, nephritis, baseline medications and SLEDAI-2K scores. 

Patients received weight-based initial intravenous infusions followed by subcutaneous injections of UST 90 mg every 8 weeks or placebo parenterally as well. The primary endpoint was a SLEDAI-2K responder index-4 (SRI-4) response at week 24.

Of the 166 patients screened, 102 were randomly assigned to UST (n=60) or PBO (n=42). The week 24 SRI-4 response rates were:

  • UST - 62%
  • PBO - 33% (p=0·006)

Adverse events were similar between groups (78% vs 67%) as were infections (45%] vs 50%). There were no deaths or opportunistic infections.

These data are encouraging for larger phase III trials studying UST in active SLE patients to proceed.

The study was funed by Janssen Research & Development, LLC.

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

Add new comment

More Like This

Mortality and Hospitalization with Pulmonary Hypertension in Systemic Sclerosis

PHAROS is a prospective cohort studying the natural history of pulmonary hypertension (PH) in systemic sclerosis (SSc). They have shown that risk factors for poor outcomes in this cohort included male sex, DLCO < 50%, exercise oxygen desaturation, and pericardial effusions. 

Noninfectious Proximal Aortitis Needs Serial Follow-ups

A Cleveland Clinic review of patients undergoing thoracic aortic surgery (1996‐2012) identified 196 patients with histopathology‐proven non‐infectious aortitis. The majority of these patients had a recognized systemic disorder, and serial assessments and imaging is crucial to an accurate diagnosis.

Ten Contemporary Challenges Facing Lupus Treatment

A group of French researchers have pooled their interests to identify the challenges ahead in the management of patients with systemic lupus erythematosus (SLE). 

Elevated Fracture Risk in Lupus

A Medicaid study of lupus (SLE) patients finds that fracture risks are elevated in low‐income SLE and lupus nephritis patients compared to those without SLE.

A cohort study matched Medicaid SLE patients and age‐ and sex‐matched non‐SLE comparators to study the primary outcome of fracture of the pelvis, wrist, hip, or humerus.

Improved Survival with Renal Transplant in SLE

The Annals of Internal Medicine has published a cohort study of lupus nephritis patients with end-stage renal disease showing that renal transplantation is associated with improved survival benefit, and a reduction in death from cardiovascular disease and infection.