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Interleukin-6 monoclonal antibody at specific dosage improved response of patients with lupus
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An interleukin-6 monoclonal antibody — as a 10 mg dose — improved the composite response of patients with lupus, according to recent phase 2 trial.
“Recently, a Pfizer anti-[interleukin-6] IL-6 (PF-04236921) demonstrated significant improvements in a composite response rate ([British Isles Lupus Assessment Group-based Composite Lupus Assessment] BICLA) and decreased flares in one of the three dosing groups,” Daniel J. Wallace, MD, associate director of the Rheumatology Fellowship Program at Cedars-Sinai Medical Center, told Healio Rheumatology.
Wallace and colleagues performed a study of 183 patients who received either placebo (n = 45) or PF-04236921 (Pfizer), an IL-6 monoclonal antibody against systemic lupus erythematosus (SLE), in doses of 10 mg (n = 45), 50 mg (n = 47) or 200 mg (n = 46) subcutaneously every 8 weeks. At week 24, the researchers assessed SLE Responder Index (SRI-4) and the BICLA.
The 200-mg dose was discontinued due to safety concerns and was not included in the efficacy analysis.
The SRI-4 did not significantly increase for any dose vs. placebo, except for the 10-mg group (59.9% vs. 40.1%). Severe flare incidence was significantly reduced when 10-mg and 50-mg groups were combined. In patients with increased disease activity at baseline, there was a significant increase in both SRI-4 (73.1% vs. 27.7%) and BICLA (55.7% vs. 19.7%) response rates for the 10-mg group. Three deaths occurred in the 200-mg group and one occurred in the 10-mg group. The most frequently reported adverse events were headache, nausea and diarrhea.
“In a phase 1 study conducted at the NIH, tociluzumab clearly had antiinflammatory actions in lupus patients,” Wallace said. He added, “Clearly, blocking IL-6 is worthy of further study in SLE.” – by Will Offit
Disclosures: Wallace reports he is a consultant for GlaxoSmithKline, Lilly, Merck Serono and UCB. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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