Crizanlizumab Reduces Priapic Events in Men with Sickle Cell Disease - MD Magazine

Crizanlizumab was associated with a halved likelihood of priapic events among treated patients with sickle compartment disease-related priapism, according to findings from a signifier 2 trial.

In caller information from the SPARTAN proceedings presented astatine the American Society of Hematology (ASH) 2022 Annual Meeting successful New Orleans past week, a squad of US investigators observed that the monoclonal antibody was associated with a simplification successful priapic episodes implicit a half-year of treatment.

Presented by Alan Anderson, MD, of the Prisma Health-Upstate Comprehensive Sickle Cell Disease Program astatine University of South Carolina School of Medicine, the investigators conducted an interim investigation of SPARTAN to measure the efficacy and information of crizanlizumab successful patients with sickle compartment illness suffering from priapism—a achy penil erection that occurs successful much than one-third of big males with sickle compartment disease.

As Anderson and colleagues noted, priapism whitethorn hap from the underlying mechanics of microcapillary vaso-occlusion successful these paitnets.

“To date, determination is nary effectual sickle compartment illness modifying cause proven to dainty priapism,” they wrote. “Crizanlizumab is simply a monoclonal antibody that binds and blocks P-selectin; a cardinal mechanistic constituent of the vaso-occlusive process. Based connected the results of the SUSTAIN trial, crizanlizumab was approved by the US Food and Drug Administration to trim the frequence of vaso-occlusive crises successful sickle compartment illness patients aged 16 years and older.”

The SPARTAN proceedings colonisation included patients ≥12 years aged with immoderate genotype of sickle compartment disease. Eligible patients had experienced ≥4 priapic episodes of ≥60 minutes successful the 14 weeks starring up to the objective trial. Patients additionally had to acquisition ≥3 priapic events during the 12-week screening play and ≥1 lawsuit wrong 4 weeks anterior to initiating treatment.

Patients logged priapic events via physics self-reporting and result surveys implicit 26 weeks, including details for the commencement and extremity date, slumber status, duration, non-pharmacological treatments, triggers, exigency section visits and symptom intensity.

Investigators treated patients with 5.0 mg/kg intravenous infusion crizanlizumab astatine weeks 1 and 3, past each 4 weeks thereafter. The analysis’ superior endpoint was percent simplification from baseline successful priapic lawsuit frequence implicit 26 weeks.

At the interim investigation cutoff of March 8, 2022, investigators had assessed 24 patients receiving ≥1 dose of crizanlizumab, and 3 patients who each missed 1 infusion. Approximately 70% of patients were aged 18 – 40 years old; median property was 29.5 years. All patients were African American. The astir communal genotype was HbSS (79.2%), and a bulk of patients (58.3%) received hydroxyurea therapy anterior to enrollment. Approximately 95% of patients reported priapism-associated pain.

Median baseline fig of priapic events per 26 weeks was 51 per patient. After 26 weeks of treatment, investigators observed priapic lawsuit simplification successful 17 of 24 patients (70.8%). Patients reported a median 53.1% simplification successful events (95% CI, -73.4 to 9.3). The play of weeks 15 – 26 were associated with a greater median percent simplification from baseline (-72.7%; 95% CI, -94.0 to -37.1) than weeks 0 – 12 (-25.0%; 95% CI, -52.9 to 1.5).

Per subgroup analyses, patients with ≥22 baseline events experienced the top payment of lawsuit simplification (-62.2%; 95% CI, -76.3 to -17.6). Crizanlizumab was associated with bully tolerability; the 2 astir communal treatment-emergent adverse events included headache (16.7%) and fatigue (12.5%).

Anderson and colleagues concluded that sickle compartment disease-related priapism was astir halved among impacted patients treated with crizanlizumab implicit 26 weeks.

“There was a inclination toward improved efficacy with a longer attraction play and successful patients with a higher fig of events astatine baseline,” they wrote. “Final results of the SPARTAN proceedings volition supply much definitive conclusions regarding the efficacy of crizanlizumab successful decreasing priapism.”

The study, “Interim Analysis of a Phase 2 Trial to Assess the Efficacy and Safety of Crizanlizumab successful Sickle Cell Disease Patients with Priapism (SPARTAN),” was presented astatine ASH 2022.