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Study finds FKB327 non-inferior to adalimumab regarding pharmacokinetics, safety

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MADRID — A novel candidate biosimilar to adalimumab known as FKB327 demonstrated non-inferiority for efficacy and safety outcomes compared with the reference therapy, according to findings presented at the EULAR Annual Congress.

Rieke H. E. Alten, MD, of the University of Berlin in Germany, presented pharmacokinetic data for 366 patients treated with FKB327 (Humira, AbbVie) and 362 patients treated with adalimumab. Both drugs were administered at a dose of 40 mg subcutaneously every other week from week 0 to week 22.

The primary endpoint was ACR20 at week 24. Secondary endpoints included DAS28 C-reactive protein (CRP) at week 24, along with ACR50, ACR70 and safety parameters.

Primary endpoint results showed that 270 patients in the FKB327 group (74.4%) and 271 patients in the adalimumab group (75.7%) reached ACR20 response. This fell within the ±13% inferiority margin.

“The primary endpoint of equivalence of ACR20 was met, with confidence intervals met well within the margin,” Alten said. “The curves are overlapping.”

The two drugs were also comparable in terms of ACR50, ACR70 and mean serum trough concentrations, according to Alten. She added that the prevalence and titers of antidrug antibodies were 61.7% for FKB327 and 59.1% for adalimumab.

Other findings showed DAS28-CRP at week 24 was 3.43 in patients treated with FKB327 and was 3.42 for those treated with adalimumab. They were also similar when observed in terms of pre-specified margins.

At least one adverse event was reported in 55.5% of patients treated with the study drug and in 61.6% of those treated with adalimumab. Serious adverse event rates were also comparable at 2.7% in the FKB327 group and at 1.4% in the adalimumab group. Nasopharyngitis was the most commonly reported event. Rates of malignancies and active tuberculosis were also low, according to Alten. “No new safety signal findings were observed,” she said.

“This phase 3 study was designed to demonstrate equivalence,” Alten concluded. “These findings demonstrate that FKB327 is a candidate biosimilar product.” — by Rob Volansky

Reference:

Alten RHE, et al. Abstract #OP0021. Presented at: EULAR Annual Congress; June 14-17, 2017; Madrid.

Disclosures: Alten reports being a consultant for Fujifilm Kyowa Kirin Biologics. Please see the study for the full list of author disclosures.