Indications for: PLEGRIDY
Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
The approval was based on efficacy data from a randomized, double-blind, placebo-controlled phase (year 1) of Study 1. Patients were randomly assigned to receive Plegridy 125 mcg (n=512) or placebo (n=500) subcutaneously once every 14 days.
The primary outcome was the annualized relapse rate (ARR) over 1 year. Secondary outcomes included the proportion of patients relapsing, number of new or newly enlarging T2 hyperintense lesions, and time to confirmed disability progression. Confirmed disability progression was defined as follows: if the baseline EDSS score was 0, a sustained 12-week increase in EDSS score of 1.5 points was required; if the baseline EDSS score was greater than 0, a sustained 12-week increase in EDSS score of 1 point was required.
At week 48, results showed the following clinical outcomes for Plegridy compared with placebo, respectively:
ARR: 0.26 vs 0.40 (relative reduction, 36%; P =.0007)
Proportion of patients with relapses: 0.19 vs 0.29 (relative risk reduction, 39%; P =.0003).
Proportion of patients with disability progression: 0.07 vs 0.11 (relative risk reduction, 38%; P =.0383).
At week 48, results showed the following MRI outcomes for Plegridy compared with placebo, respectively:
Mean number of new or newly enlarging T2 hyperintense lesions: 3.6 vs 10.9 (relative reduction, 67%; P <.0001).
Mean number of Gd enhancing lesions: 0.2 vs 1.4 (relative reduction, 86%; P <.0001).
See full labeling. May give by SC inj in abdomen, back of the upper arm, or by SC or IM inj in thigh(s). Rotate inj sites. Initially 63mcg on Day 1, increase to 94mcg on Day 15, then 125mcg on Day 29 and every 14 days thereafter. May give analgesics and/or antipyretics for flu-like symptoms. Switching between SC and IM inj or vice versa has not been studied.
Depression. Suicidal ideation. Consider discontinuing if depression or other severe psychiatric symptoms occur. Seizure disorder. Discontinue if serious allergic reactions occur. Significant cardiac disease; monitor for worsening condition at initiation and during treatment. Risk of thrombotic microangiopathy; discontinue if occurs. Monitor for hepatic injury, infections, bleeding, anemia. Myelosuppression. Obtain CBCs with differential and platelets during treatment. Consider discontinuing if new autoimmune disorder develops. Latex allergy (IM syringe cover). Severe renal impairment: monitor. Pregnancy. Nursing mothers.
Inj site reactions (erythema, pain, pruritus, necrosis, cellulitis, abscess), influenza-like illness, pyrexia, headache, myalgia, chills, asthenia, arthralgia; hepatic injury, seizures, CHF, hematologic or autoimmune disorders, rare: serious allergic reactions (discontinue if occurs).
To enroll women exposed to Plegridy during pregnancy call (866) 810-1462 or visit https://www.plegridypregnancyregistry.com/.
The major pathway of elimination is renal. The half-life is approximately 78 hours in multiple sclerosis patients.
Generic Drug Availability:
For SC: single-dose prefilled pens (125mcg/0.5mL)—2; single-dose prefilled syringes (125mcg/0.5mL)—2; Starter Pack (pens and syringes)—2 (63mcg/0.5mL + 94mcg/0.5mL); For IM: single-dose prefilled syringes (125mcg/0.5mL)—2; Titration Kit (syringes)—2 (63mcg/0.5mL + 94mcg/0.5mL)