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A year's treatment with intravenous abatacept resulted in few complete responses and failed to eliminate flares in patients with in active lupus nephritis, although it did reduce disease markers.
Furie R, Nicholls K, Cheng TT, Houssiau, et al., Efficacy and Safety of Abatacept in Lupus Nephritis: A Twelve-Month, Randomized, Double-Blind Study.Arthritis & Rheumatology. (2014) 66:379–389. DOI: 10.1002/art.38260
A year's treatment with intravenous abatacept resulted in few complete responses and failed to eliminate flares in patients with in active lupus nephritis (LN) -- but the drug did reduce key markers of disease activity, according to results of a multinational clinical trial.
A total of 298 patients with active class III or IV LN taking mycophenolate mofetil and/or glucocorticoids were randomly given placebo or treated for 3 months with intravenous abatacept -- either at the standard weight-tiered dose (about 10 mg/kg) or 30 mg/kg of abatacept, followed by the standard 30/10 mg weight-tiered dose.
A majority of the patients at the 85 study sites were women in their early 30s, mostly Asian or Caucasian.
Few treated patients (22% and 27% of each abatacept group) achieved a complete response at any time over the year, according to stringent standards adopted from American College of Rheumatology criteria: a urinary protein-to-creatinine ratio below 0.20 gm/gm, inactive urine sediment, and a normal estimated glomerular filtration rate (eGFR), or a decline of less than 25% from baseline.
Similar proportions of patients in the treatment groups experienced a complete clinical response. Only among those with nephrotic-range proteinuria (n=122) did abatacept produce a greater reduction than placebo in the mean urinary protein-to-creatinine ratio.
Additionally, all patients experienced at least one moderate or severe flare (classed as British Isles Lupus Assessment Group [BILAG] B flares or BILAG A flares, respectively).
Abatacept did produce greater improvements from baseline levels of anti–double-stranded DNA antibodies, C3, and C4.
The drug was well tolerated with only a few adverse or serious adverse events, mostly gastroenteritis and herpes zoster.