INDICATION

EVENITY® is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy...Read More

The anabolic effect of EVENITY® wanes after 12 monthly doses of therapy. Therefore, the duration of EVENITY® use should be limited to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an antiresorptive agent should be considered. Close
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Head-to-head fracture study vs alendronate in post-fracture women with postmenopausal osteoporosis1,2

EVENITY® was compared with a commonly prescribed antiresorptive1,2

Phase 3 event-driven study in postmenopausal women with osteoporosis receiving EVENITY® first followed by alendronate vs alendronate alone

PO, orally; QM, monthly; QW, weekly; SC, subcutaneous.

The primary analysis was planned for when clinical fracture events had been confirmed in at least 330 patients and all patients had completed the month 24 visit.2

Study design1

A randomized, double-blind, alendronate-controlled study of postmenopausal women aged 55 to 90 years with:

  • BMD T-score ≤ –2.5 at the total hip or femoral neck and either one moderate or severe vertebral fracture or two mild vertebral fractures, or
  • BMD T-score ≤ –2.0 at the total hip or femoral neck and either two moderate or severe vertebral fractures or a history of a proximal femur fracture

After the 12-month treatment period, women in both arms transitioned to open-label alendronate while remaining blinded to their initial treatment. This was an event-driven trial.

Untreated patient population2,3

More than 98% of patients enrolled had a previous fracture and less than 10% had been on any previous treatment.

Dosing1

4,093 women were randomized to receive either monthly subcutaneous injections of EVENITY® (n=2,046) or weekly oral alendronate (n=2,047) for 12 months.

  • All women were supplemented with daily calcium and vitamin D

Primary endpoints1

  • Incidence of morphometric vertebral fracture at 24 months
  • Time to first clinical fracture (nonvertebral and symptomatic vertebral fracture) through the primary analysis, which was performed when at least 330 subjects had a clinical fracture, and all subjects had completed the 24-month visit

BMD=bone mineral density.

EVENITY® for 12 months followed by alendronate provided superior vertebral and nonvertebral fracture risk reduction vs alendronate alone1

Start with EVENITY® first after fracture when your patients’ risk of another is at its highest

EVENITY® first followed by alendronate vs alendronate alone1,2

This was an event-driven trial and the duration of follow-up varied across subjects. The median duration of subject follow-up for the primary analysis period was 33 months.1

EVENITY® for 12 months followed by alendronate reduced the incidence of clinical fracture (nonvertebral and symptomatic vertebral fracture) at primary analysis (median 33 months) (P < 0.001).1

*Absolute and relative risk reductions are based on the Mantel-Haenszel method adjusting for age strata, baseline total hip BMD T-score (≤ –2.5, > –2.5), and presence of severe vertebral fracture at baseline.1

†P value based on logistic regression model (new vertebral fracture) or Cox proportional hazards model (other fracture types) adjusting for age strata, baseline total hip BMD T-score, and presence of severe vertebral fracture at baseline.1

‡Nonvertebral fractures excluded fractures of the skull, facial bones, metacarpals, fingers, and toes. Pathologic or high trauma fractures were also excluded.4

ARR=absolute risk reduction.

EVENITY® rapidly increased BMD in just 12 months1

BMD superiority vs alendronate across key sites1

  • Within 12 months vs alendronate, EVENITY® demonstrated significant improvements in BMD at the lumbar spine, total hip, and femoral neck
  • Gains were sustained after follow-up treatment with alendronate

EVENITY® first followed by alendronate vs alendronate alone BMD gains at 12, 24, and 36 months4

*Number of subjects with values at baseline and at least one post-baseline visit at or before month 36.4

†P < 0.001 based on ANCOVA model using last-observation-carried-forward (LOCF) adjusting for treatment, age strata, presence of severe vertebral fracture at baseline, baseline BMD value, machine type, and baseline BMD value-by-machine type interaction.4

Consider the safety profile of EVENITY® in the 12-month double-blind period of the head-to-head study vs alendronate1

Major adverse cardiac events (MACE)1,*

ARCH Tableone

ARCH MACE Hazard Ratio: 1.87 (CI: 1.11–3.14) for EVENITY® compared to alendronate.1

*MACE is a composite endpoint of positively adjudicated nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death.1

†These events occurred in patients with and without a history of myocardial infarction or stroke.1

‡Includes fatal events adjudicated as CV-related or undetermined.2

CV, cardiovascular.

Adverse reactions occurring in ≥ 2% of EVENITY®-treated women in the double-blind portion of the ARCH trial1,*

ARCH_Tabletwo

Adjudicated Cases of ONJ & AFF2

4,054 patients were evaluated during the safety analysis1

  • No positively adjudicated cases of ONJ2
  • No positively adjudicated cases of AFF2

*Adverse reactions based on occurrence in ≥ 2% of EVENITY®-treated patients in either FRAME or ARCH and a plausible relationship to EVENITY®.1

AFF, atypical femoral fracture; ONJ, osteonecrosis of the jaw.

See structure study results: evenity® vs teriparatide

References: 1. EVENITY® (romosozumab-aqqg) prescribing information, Amgen. 2. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377:1417-1427. 3. Data on file, Amgen; 2017. 4. Saag KG, Petersen J, Brandi ML, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med. 2017;377(suppl):1417-1427.

IMPORTANT SAFETY INFORMATION FOR EVENITY®

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH

EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the benefits outweigh the risks in patients with other cardiovascular risk factors. Monitor for signs and symptoms of myocardial infarction and stroke and instruct patients to seek prompt medical attention if symptoms occur. If a patient experiences a myocardial infarction or stroke during therapy, EVENITY® should be discontinued.

In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY® compared to those treated with alendronate.

Contraindications: EVENITY® is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating therapy with EVENITY®. EVENITY® is contraindicated in patients with a history of systemic hypersensitivity to romosozumab or to any component of the product formulation. Reactions have included angioedema, erythema multiforme, and urticaria.

Hypersensitivity: Hypersensitivity reactions, including angioedema, erythema multiforme, dermatitis, rash, and urticaria have occurred in EVENITY®-treated patients. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of EVENITY®.

Hypocalcemia: Hypocalcemia has occurred in patients receiving EVENITY®. Correct hypocalcemia prior to initiating EVENITY®. Monitor patients for signs and symptoms of hypocalcemia, particularly in patients with severe renal impairment or receiving dialysis. Adequately supplement patients with calcium and vitamin D while on EVENITY®.

Osteonecrosis of the Jaw (ONJ): ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients receiving EVENITY®. A routine oral exam should be performed by the prescriber prior to initiation of EVENITY®. Concomitant administration of drugs associated with ONJ (chemotherapy, bisphosphonates, denosumab, angiogenesis inhibitors, and corticosteroids) may increase the risk of developing ONJ. Other risk factors for ONJ include cancer, radiotherapy, poor oral hygiene, pre-existing dental disease or infection, anemia, and coagulopathy.

For patients requiring invasive dental procedures, clinical judgment should guide the management plan of each patient. Patients who are suspected of having or who develop ONJ should receive care by a dentist or an oral surgeon. In these patients, dental surgery to treat ONJ may exacerbate the condition. Discontinuation of EVENITY® should be considered based on benefit-risk assessment.

Atypical Femoral Fractures: Atypical low-energy or low trauma fractures of the femoral shaft have been reported in patients receiving EVENITY®. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated.

During EVENITY® treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be evaluated to rule out an incomplete femur fracture. Interruption of EVENITY® therapy should be considered based on benefit-risk assessment.

Adverse Reactions: The most common adverse reactions (≥ 5%) reported with EVENITY® were arthralgia and headache.

EVENITY® is a humanized monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

Please see EVENITY® full Prescribing Information, including Medication Guide.

IMPORTANT SAFETY INFORMATION FOR EVENITY®

POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE, AND CARDIOVASCULAR DEATH

EVENITY® may increase the risk of myocardial infarction, stroke and cardiovascular death. EVENITY® should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year. Consider whether the

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