Cutaquig enables modified subcutaneous immunoglobulin infusion regimens

SAN ANTONIO — Cutaquig provided safe and effective dosing flexibility for patients with primary immunodeficiency disease, according to data presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting.

“We conducted this phase 3 clinical trial to try to see if we could enhance the expediency of the infusion experience for patients who are on subcutaneous immunoglobulin,” Joanna Maltese, BSN, RN, clinical nurse educator at Octapharma, told Healio.

The researchers designed three modified infusion regimens for Cutaquig (Octapharma AG), which is a 16.5% subcutaneous immunoglobulin (SCIG), to achieve dosing with fewer needle sticks, shorter durations or less frequent administration.

In the first regimen, the researchers increased volume per site with a maximum of 100 mL per site by reducing the total number of injection sites and maintaining similar flow rates compared with standard therapy.

The second regimen increased the infusion rate per site until a maximum flow rate of 100 hours per site — or the maximum flow rate per investigator decision — was reached. Regimen three doubled the patients’ weekly dose but administered doses every other week.

Cohort 1 (n = 15; mean age, 51.2 years; standard deviation [SD], 17.269; 66.7% female), which used the first regimen, achieved a maximum realized volume of 108 mL per site. Also, five (33.3%) patients attained 90% or more of the allowed maximum volume of 100 mL per site.

“That’s important, especially as subcutaneous therapy is being used more for immunomodulatory doses of IG because patients are going to be on much larger volume, and so the ability to tolerate those volumes is important to patients,” Maltese said.

This regimen also exceeded the labeled maximum of up to 40 mL per site for adults, the researchers said, but its mean number of infusion sites was 2.3 compared with 3.3 for cohort 2 on the second regimen and 3.9 for cohort 3 on the third regimen.

Cohort 2 (n = 15; mean age, 47.88 years; SD, 20.53; 73.3% female) achieved a maximum realized infusion flow rate of 67.5 mL per hour per site. According to the researchers, this indicates that higher infusion rates were well tolerated and reduced infusion duration, compared with the current label’s 52 mL per hour per site maximum.

Using the third regimen, cohort 3 (n = 34; mean age, 50.81 years; SD, 18.544; 79.4% female) experienced mean total trough levels for dosing every other week that were equivalent to weekly dosing (P = .0017), the researchers said.

“In each of these cohorts, patient convenience was greatly impacted because patients were able either to drop needles, so there were fewer needle sticks, or have shorter infusion times, or they did not have to infuse as often,” Maltese said.

The patients did not experience any serious bacterial infections, with 67.2% (n = 43) experiencing a total of 77 infection-only adverse events primarily categorized as mild (23.4%) or moderate (56.3%).

Also, according to the researchers, most patients said the new regimens were better or somewhat better than their previous regimens.

“Patients at the end of the trial said that their quality of life and their experience in transitioning to Cutaquig from their other product was easy or very easy,” Maltese said.

“It’s lifelong therapy,” she continued. “People choose subcutaneous over intravenous IG for the convenience and the lifestyle. In giving them ways to improve their convenience and lifestyle, we’re hoping to improve their quality of life.”