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Strensiq® improved movement in patients with perinatal/infantile- or juvenile-onset hypophosphatasia (HPP).1,8

 
GO TO THE VIDEO
 

Mobility

Mobility and gait improved in patients with juvenile-onset hypophosphatasia treated with Strensiq®.1

At 48 months, all treated patients had percent-predicted 6-minute walk test (6MWT) values within the normal range1,a,b

Mean distance walked as measured by 6MWT1,8,a

Mobility was measured using the 6MWT, an established measure of walking ability10

aMobility was assessed in Study 3 in patients 6 to 12 years of age with juvenile-onset hypophosphatasia using the 6MWT.1 Minimal clinically important difference (MCID) has been estimated to be approximately 30 meters.10

b6MWT results were converted to mean percent-predicted values. Obtained values were expressed as a percentage of those observed in sex-, age-, and height-matched healthy children.8

Patients treated with Strensiq® saw improvements in gait vs untreated historical controls.1,a

75% of patients (6 out of 8) treated with Strensiq had an improvement in step length while only 17% of the untreated controls (1 out of 6) showed any improvement in step length1

aGait improvements were assessed in Study 3 using the Modified Tinetti Performance-Oriented Mobility Assessment-Gait (MPOMA-G) subtest in 8 patients 6 to 12 years of age treated with Strensiq at 6-month intervals out to 36 months, and were compared with untreated historical controls (n=6).1

Strensiq® Patient Video
6-Minute Walk Test (6MWT)

(6MWT at baseline and 24 months)

 

The above video shows a patient during the 6MWT at baseline and at 24 months8

Results for the patient at baseline, 24 months, and 48 months are compared to the study mean in the Summary of Results table, below. The patient was 7 years, 3 months of age at study baseline and 9 years, 2 months of age at the 24-month (96-week) follow-up evaluation8

Summary of Results

Baseline 24 Months 48 Months
Patient in Video 217 meters [age 7 years]
(41% of predicted normal distance)a
438 meters [age 9 years]
(76% of predicted normal distance)a
559 meters [age 11 years]
(91% of predicted normal distance)a
Study Mean (SD) n=8
343 meters
(90.9)
(41% of predicted normal distance)a
n=7
528 meters
(33.4)
(83% of predicted normal distance)a
n=6
588 meters
(36.7)
(89% of predicted normal distance)a

a6-minute walk test results were converted to mean percent-predicted values. Obtained values were expressed as a percentage of those observed in sex-, age-, and height-matched healthy children.8 Minimal clinically important difference (MCID) has been estimated to be approximately 30 meters.10

Results in adult patients with perinatal/infantile- and juvenile-onset hypophosphatasia with Strensiq®.8,18

Median distance walked as measured by the 6MWT8

aBaseline distance includes patients in the control group (n=3) and those treated with Strensiq (n=7) for the first 24 weeks of the study.
At 192 weeks, patients in the control group had not yet reached 192 weeks of therapy and 1 patient did not complete the 6MWT.8,18
Minimal clinically important difference (MCID) has been estimated to be approximately 30 meters.10

Decreases in plasma PPI and PLP were observed at week 24. These differences were not significantly different than those of the control group at 24 weeks.8 Reduction in plasma PPI and PLP did not correlate with clinical outcomes.1

Speed and Agility

Speed and agility improved in patients treated with Strensiq®.8

The median score for speed and agility was within 1 standard deviation of the normal mean at 192 weeks8

Median speed and agility over time8,a

aSpeed and agility were assessed in patients 6 to 12 years of age in Study 3 using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2).8 The BOT-2 assesses motor proficiency in normally developing individuals as well as in those with moderate motor deficits. Proficiency is normalized and reported in scaled scores.11

Indication

STRENSIQ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP)1

Important Safety Information

  • Hypersensitivity reactions, including anaphylaxis, have been reported in STRENSIQ-treated patients. Signs and symptoms consistent with anaphylaxis included difficulty breathing, choking sensation, nausea, periorbital edema, and dizziness. These reactions have occurred within minutes after subcutaneous administration of STRENSIQ and can occur in patients on treatment for more than one year. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus and oral hypoesthesia. If a severe hypersensitivity reaction occurs, discontinue STRENSIQ treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering STRENSIQ to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
  • Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ. Advise patients to follow proper injection technique and to rotate injection sites.
  • Patients with HPP are at increased risk for developing ectopic calcifications. In clinical trials, 14 cases (14%) of ectopic calcification of the eye including the cornea and conjunctiva, and the kidneys (nephrocalcinosis) were reported. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported. Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with STRENSIQ to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function.
  • The most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions.