A new study has reviewed key results of the SOLACE trial of crizanlizumab for adults with sickle cell disease (SCD) and found no new safety issues as well as confirmed the drug’s efficacy.

The study, published in Blood Advances, confirmed its efficacy was consistent with results of the SUSTAIN trial and reviewed the pharmacokinetics and pharmacodynamics of the therapy.

“In the phase 2 SUSTAIN study, crizanlizumab 5.0 mg/kg (SelG1) reduced the annualized rate of vaso-occlusive crises [VOCs] leading to a healthcare visit by 45.3% versus placebo (P =.01) in SCD patients, regardless of SCD genotype or concomitant use of hydroxyurea (HU),” the authors wrote. “We report interim results from the phase 2, open-label SOLACE-adults study evaluating the long-term pharmacokinetics, pharmacodynamics, safety and efficacy of crizanlizumab 5.0 and 7.5 mg/kg.”

The research team included 57 adult patients with SCD in the ongoing phase 2, multicenter, open-label SOLACE trial for adults. Forty-five patients received 5.0 mg/kg of crizanlizumab and 12 received 7.5 mg/kg. The enrollment cutoff date was August 1, 2020. The primary objective of the trial was to assess the pharmacokinetics and pharmacodynamics of crizanlizumab at the initial does and at steady state. Secondary objectives were to assess the safety and efficacy of crizanlizumab, including VOCs, as part of the efficacy assessment.

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The therapy had a generally favorable safety profile consistent with that reported in the previous SUSTAIN study, with no new safety issues observed in the SOLACE trial; just 1 patient per dose group discontinued the treatment due to adverse events. The authors do, however, recommend that patients taking crizanlizumab be closely monitored for potential signs of infusion-related reactions.

The authors conclude that crizanlizumab demonstrated sustained safety and efficacy after more than 12 months of therapy in individuals with SCD and a history of VOCs.

Reference

Kanter J, Clark Brown R, Norris C, et al. Pharmacokinetics, pharmacodynamics, safety and efficacy of crizanlizumab in patients with sickle cell disease. Blood Adv. Published online November 16, 2022. doi:10.1182/bloodadvances.2022008209