Simponi Aria

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Simponi Aria Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Golimumab 50mg/4mL; soln for IV infusion after dilution; preservative- and latex-free.

    Pharmacological Class

    TNF-alpha blocker.

    How Supplied

    Single-use vial—1

    How Supplied

    Simponi Aria (golimumab) Injection is a colorless to light yellow solution available in packs of 1 vial. Each single-dose vial contains 50 mg of Simponi Aria per 4 mL of solution.

    Storage

    Refrigerate Simponi Aria at 36⁰F to 46⁰F (2⁰C to 8⁰C) and protect from light. Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake.

    If needed, Simponi Aria may be stored at room temperature up to 77⁰F (25⁰C) for a maximum single period of 30 days in the original carton to protect from light. Once Simponi Aria has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard Simponi Aria.

    Manufacturer

    Janssen Biotech, Inc.

    Generic Availability

    NO

    Simponi Aria Indications

    Indications

    Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX) in adults. Active psoriatic arthritis (PsA) in patients ≥2yrs. Active ankylosing spondylitis (AS) in adults. Active polyarticular juvenile idiopathic arthritis (pJIA) in patients ≥2yrs.

    Simponi Aria Dosage and Administration

    Prior to Treatment Evaluations

    Prior to initiating Simponi Aria and periodically during therapy, evaluate patients for active tuberculosis and tested for latent infection. Prior to initiating Simponi Aria, patients should be tested for hepatitis B viral infection.

    Prior to initiating Simponi Aria, consider the risks and benefits of treatment:

    • with chronic or recurrent infection; 

    • who have been exposed to tuberculosis; 

    • with a history of an opportunistic infection; 

    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or 

    • with underlying conditions that may predispose them to infection. 

    Test all patients for HBV infection prior to initiating Simponi Aria.

    Consider the risks and benefits of TNF-blocker treatment, including Simponi Aria, prior to initiating therapy in patients with a known malignancy other than a successfully treated nonmelanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy.  

    Adult

    Infuse over 30mins. RA, PsA, AS: 2mg/kg IV at Weeks 0 and 4, then every 8 weeks thereafter. RA: give with MTX.

    Children

    <2yrs: not established. Infuse over 30mins. Base dose on body surface area. PsA, pJIA (2–17yrs): 80mg/m2 at Weeks 0 and 4, then every 8 weeks thereafter.

    Simponi Aria Contraindications

    Not Applicable

    Simponi Aria Boxed Warnings

    Boxed Warning

    Serious infections. Malignancy.

    Boxed Warning

    Serious infections 

    • Increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

    • Discontinue Simponi Aria if a patient develops a serious infection.

    • Reported infections with TNF blockers, of which Simponi Aria is a member, include:

      • Active tuberculosis, including reactivation of latent tuberculosis. Test patients for latent tuberculosis before Simponi Aria use and during therapy. Initiate treatment for latent TB prior to Simponi Aria use.  

      • Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

      • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

    • Consider the risks and benefits of treatment with Simponi Aria prior to initiating therapy in patients with chronic or recurrent infection. 

    • Monitor closely for signs and symptoms of infection during and after treatment with Simponi Aria, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

    Malignancy

    • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, of which Simponi Aria is a member.

    Simponi Aria Warnings/Precautions

    Warnings/Precautions

    Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring or opportunistic infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, new or worsening CHF, hematological abnormality (eg, cytopenias), lupus-like syndrome, or serious hypersensitivity reaction develops. Malignancies. Perform periodic skin exams (esp. those with skin cancer risk factors). Update immunizations based on current guidelines prior to initiating therapy. CHF (monitor). Immunosuppression. Demyelinating disorders (eg, MS, Guillain-Barré syndrome); consider discontinuing if develop. Elderly. Infants (see Interactions). Pregnancy. Nursing mothers.

    Warnings/Precautions

    Serious Infections

    • Increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. 

    • The concomitant use of a TNF blocker and abatacept or anakinra is not recommended due to a higher risk of serious infections.

    • Do not initiate in patients with an active infection, including clinically important localized infections.

    • Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection. 

    • Prior to initiating Simponi Aria, consider the risks and benefits of treatment:

      • with chronic or recurrent infection;  

      • who have been exposed to tuberculosis;  

      • with a history of an opportunistic infection;  

      • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or  

      • with underlying conditions that may predispose them to infection.

    • Monitoring: 

      • Monitor closely for signs and symptoms of infection during and after treatment with Simponi. 

      • Discontinue if a patient develops a serious infection, an opportunistic infection, or sepsis. 

      • If a new infection develops during treatment with Simponi: perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, initiate appropriate antimicrobial therapy, and closely monitor them. 

    • Tuberculosis: 

      • Prior to initiating Simponi Aria and periodically during therapy, evaluate for tuberculosis risk factors and test for latent infection.

      • Assess if treatment for latent tuberculosis is needed prior to initiating therapy; an induration of 5 mm or greater is a positive tuberculin skin test, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).

      • Monitor for signs and symptoms of tuberculosis including patients who tested negative for latent tuberculosis infection prior to initiating therapy, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection.

      • Consider anti-tuberculosis therapy prior to initiation of Simponi Aria in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection.

      • Consider tuberculosis in the differential diagnosis in patients who develop a new infection during Simponi Aria treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.

    • Invasive Fungal Infections:

      • If patients develop a serious systemic illness and they reside or travel in regions where mycoses are endemic, consider invasive fungal infection in the differential diagnosis. Consider appropriate empiric antifungal therapy, and take into account both the risk for severe fungal infection and the risks of antifungal therapy while a diagnostic workup is being performed. 

    • Hepatitis B Virus Reactivation:

      • Test all patients for HBV infection before initiating. If positive for hepatitis B surface antigen, consultation with an expert physician in the treatment of hepatitis B is recommended before initiating.

      • Considered risks and benefits of treatment to patients who are carriers of HBV prior to prescribing TNF blockers. 

      • For patients who are carriers of HBV and require treatment with TNF blockers: monitor closely for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy.

      • Discontinue and initiate antiviral therapy with appropriate supportive treatment if HBV reactivation occurs. The safety of resuming TNF blockers after HBV reactivation has been controlled is not known. Use caution when considering resumption of TNF blockers in this situation and monitor patients closely.

    Malignancies

    • Malignancies in Pediatric Patients:

      • Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including golimumab.

      • Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. 

    • Malignancies in Adult Patients:

      • Consider the risks and benefits of TNF-blocker treatment including Simponi Aria prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing a TNF-blocker in patients who develop a malignancy.

      • Patients with rheumatoid arthritis (RA) and other chronic inflammatory diseases, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk (up to several fold) than the general population for the development of lymphoma, even in the absence of TNF-blocking therapy.

      • Rare postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF-blocking agents. Nearly all of the reported TNF-blocker associated cases have occurred in patients with Crohn's disease or ulcerative colitis. The majority were in adolescent and young adult males. 

      • Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including Simponi Aria. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

    Congestive Heart Failure 

    • Simponi Aria has not been studied in patients with a history of CHF. Use caution in patients with CHF. 

    • If a decision is made to administer Simponi Aria to patients with CHF, monitor closely during therapy, and discontinue if new or worsening symptoms of CHF appear. 

    Demyelinating Disorders

    • Use caution in considering the use of TNF blockers, including Simponi Aria, in patients with central (e.g., multiple sclerosis) or peripheral (e.g., Guillain-Barré syndrome) nervous system demyelinating disorders. 

    • Consider discontinuing if these disorders develop.

    Autoimmunity

    • Discontinue If symptoms suggestive of a lupus-like syndrome develop following treatment with Simponi Aria.

    Use with Abatacept 

    • The concomitant administration of another TNF blocker and abatacept was associated with a greater proportion of serious infections than the use of a TNF blocker alone; and the combination therapy, compared to the use of a TNF blocker alone, has not demonstrated improved clinical benefit in the treatment of RA.

    • The combination of TNF blockers, including Simponi Aria, and abatacept is not recommended.

    Use with Anakinra

    • Concurrent administration of anakinra (an interleukin-1 antagonist) and another TNF blocker was associated with a greater portion of serious infections and neutropenia and no additional benefits compared with the TNF-blocker alone. 

    • The combination of anakinra with TNF blockers, including Simponi Aria, is not recommended.

    Switching Between Biological Disease Modifying Antirheumatic Drugs (DMARDs) 

    • Care should be taken when switching from one biologic product to another biologic product since overlapping biological activity may further increase the risk of infection.

    Hematologic Cytopenias

    • Caution should be exercised when using TNF blockers, including Simponi Aria, in patients who have or have had significant cytopenias. 

    Vaccinations/Therapeutic Infectious Agents

    • Live Vaccines:

      • Avoid live vaccines in patients treated with Simponi Aria. 

      • Administration of live vaccines to infants exposed to Simponi Aria in utero is not recommended for 6 months following the mother’s last Simponi Aria infusion during pregnancy.

      • Whenever possible update immunizations prior to initiation of treatment with Simponi Aria following current immunization guidelines for patients receiving immunosuppressive agents. Advise patients to discuss with the physician before seeking any immunizations.

    • Therapeutic Infectious Agents:

      • Do not administer therapeutic infectious agents concurrently with Simponi Aria.

    Hypersensitivity Reactions

    • Discontinue immediately and institute appropriate therapy if an anaphylactic or other serious allergic reaction occurs. 

    Pregnancy Considerations

    Risk Summary

    • Monoclonal antibodies, such as golimumab, are transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. 

    Clinical Considerations

    • Fetal/Neonatal Adverse Reactions: Golimumab crosses the placenta during pregnancy. Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants.

    • Infants may be at increased risk of infection. Administration of live vaccines to infants exposed to Simponi in utero is not recommended for 6 months following the mother’s last Simponi injection during pregnancy.

    Nursing Mother Considerations

    Risk Summary

    • There is no information regarding the presence of Simponi Aria in human milk, the effects on breastfed infants, or the effects on milk production.

    • The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for Simponi Aria and any potential adverse effects on the breastfed infants from Simponi Aria, or from the underlying maternal condition.

    Pediatric Considerations

    The safety and effectiveness in pediatric patients below the age of 2 years have not been established in pJIA or in PsA. The safety and effectiveness of Simponi Aria in pediatric patients with conditions other than pJIA and PsA have not been established.

    Geriatric Considerations

    In Trial RA, the number of patients ages 65 or older was too small to make comparisons with younger Simponi Aria-treated patients. Because there is a higher incidence of infections in the geriatric population in general, caution should be used in treating geriatric patients with Simponi Aria.

    Simponi Aria Pharmacokinetics

    Absorption

    Following a single intravenous administration of 2 mg/kg Simponi Aria, a mean Cmax of 44.4 ± 11.3 mcg/mL was observed in patients with RA. Data directly comparing 2 mg/kg intravenous administration and 50 mg subcutaneous administration are not available.

    Distribution

    Following a single intravenous administration of 2 mg/kg Simponi Aria, the mean volume of distribution was estimated to be 115 ± 19 mL/kg in healthy subjects, and 151 ± 61 mL/kg in patients with RA. The volume of distribution of golimumab may indicate that golimumab is distributed primarily in the circulatory system with limited extravascular distribution.

    Elimination

    Following a single intravenous administration of 2 mg/kg Simponi Aria,, the systemic clearance of golimumab was estimated to be 6.9 ± 2.0 mL/day/kg in healthy subjects and 7.6 ± 2.0 mL/day/kg in patients with RA. The mean terminal half-life was estimated to be 12 ± 3 days in healthy subjects and the mean terminal half-life in RA patients was 14 ± 4 days.

    Simponi Aria Interactions

    Interactions

    Concurrent abatacept, anakinra, live vaccines, therapeutic infectious agents, or other TNF blockers: not recommended. Infants exposed to golimumab in utero: do not give live vaccines for 6 months after mother’s last inj during pregnancy. Concomitant immunosuppressants (eg, corticosteroids, MTX) may increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and may need dose adjustments of these drugs. Caution with switching between DMARDs; overlapping may further increase the risk of infection.

    Simponi Aria Adverse Reactions

    Adverse Reactions

    Upper RTI, elevated liver enzymes, viral infection, decreased neutrophil count, bronchitis, hypertension, rash; other serious infections, malignancies (eg, melanoma, lymphoma; monitor), blood dyscrasias, new or worsening CHF, antibody formation.

    Simponi Aria Clinical Trials

    Clinical Trials

    Rheumatoid Arthritis

    The efficacy and safety of Simponi Aria were evaluated in one multicenter, randomized, double-blind, controlled trial (Trial RA, NCT00973479) in 592 patients ≥18 years of age with moderately to severely active RA despite concurrent MTX therapy and had not previously been treated with a biologic TNF-blocker. Patients were randomly assigned to receive either Simponi Aria 2 mg/kg (N=395) or placebo (N=197) over a 30-minute intravenous infusion at Weeks 0, 4 and every 8 weeks thereafter in addition to their weekly maintenance MTX dose (15-25 mg). 

    All patients receiving placebo + MTX received Simponi Aria + MTX after Week 24, but the trial remained blinded until all patients had completed 108 weeks of treatment. Efficacy data were collected and analyzed through Week 52. The primary endpoint in Trial RA was the percentage of patients achieving an American College of Rheumatology (ACR) 20 response at Week 14.

    Clinical Response: Results showed that treatment with Symponi Aria ± MTX achieved the following ACR responses vs placebo ± MTX, respectively:

    • ACR 20

      • Week 14: 59% vs 25% (for difference in proportions with 95% CI, 25.9-41.4)

      • Week 24: 63% vs 32% (for difference in proportions with 95% CI, 23.3-39.4)

    • ACR 50

      • Week 14: 30% vs 9% (for difference in proportions with 95% CI, 15.3-27.2)

      • Week 24: 35% vs 13% (for difference in proportions with 95% CI, 15.1-28.4)

    • ACR 70

      • Week 14: 12% vs 3% (for difference in proportions with 95% CI, 5.3-13.4)

      • Week 24: 18% vs 4% (for difference in proportions with 95% CI, 8.8-18.1)

    At week 14, treatment with Symponi Aria ± MTX also achieved the following improvements in the components of ACR response vs placebo ± MTX, respectively:

    • Number of swollen joints (0-66): 

      • Baseline: 15 vs 15

      • Week 14: 6 vs 11

    • Number of tender joints (0-68): 

      • Baseline: 26 vs 26

      • Week 14: 13 vs 20

    • Patient’s assessment of pain (0-10): 

      • Baseline: 6.5 vs 6.5

      • Week 14: 3.9 vs 5.6

    • Patient’s global assessment of disease activity (0-10): 

      • Baseline: 6.5 vs 6.5

      • Week 14: 4.0 vs 5.5

    • Physician’s global assessment of disease activity (0-10): 

      • Baseline: 6.2 vs 6.3

      • Week 14: 3.1 vs 4.9

    • HAQ score (0-3): 

      • Baseline: 1.6 vs 1.6

      • Week 14: 1.1 vs 1.4

    • CRP (mg/dL): 

      • Baseline: 2.8 vs 2.2

      • Week 14: 0.9 vs 1.8

    At Week 14, a greater proportion of patients treated with Symponi Aria + MTX achieved a low level of disease activity as measured by a DAS28-CRP less than 2.6 compared with the placebo + MTX group (15% vs 5%; 95% CI for difference [6.3%, 15.5%]).

    Radiographic Response: In Trial RA, structural joint damage was assessed radiographically and expressed as a change in van der Heijde-Modified Sharp Score (vdH-S) and its components, the erosion score and Joint Space Narrowing (JSN) score, at Week 24 compared to baseline. Treatment with Symponi Aria + MTX inhibited the progression of structural damage with a mean change in total vdH-S score of 0.03 at week 24 compared with 1.1 for placebo + MTX (P ≤.001).

    At Week 24, 71% of patients treated with Symponi Aria + MTX had no progression of structural damage (change in the total vdH-S score ≤ 0), compared with 57% of patients treated with placebo + MTX. At Week 52, the mean change from baseline in total vdH-S score was 1.2 in patients originally randomized to placebo + MTX who crossed over to Symponi Aria + MTX at Week 16 or Week 24, and 0.1 in patients originally randomized to Symponi Aria + MTX who remained on active treatment.

    Physical Function Response in Patients with RA: Physical function was assessed by the disability index of the Health Assessment Questionnaire (HAQ-DI). At Week 14, the Symponi Aria + MTX group achieved a greater mean improvement in the HAQ-DI compared with placebo + MTX (0.5 vs 0.2; 95% CI for difference [0.2, 0.4]).

    Other Health-Related Outcomes: In Trial RA, patients treated with Symponi Aria + MTX achieved greater improvement from baseline compared with placebo + MTX in physical component summary (PCS), mental component summary (MCS) scores and in all 8 domains of the SF-36. Fatigue was assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) in Trial RA. Treatment with Symponi Aria resulted in improvement in fatigue as measured by FACIT-F.

     

    Psoriatic Arthritis 

    The efficacy and safety of Symponi Aria were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial in 480 patients ≥ 18 years of age with active psoriatic arthritis despite NSAID or DMARD therapy (Trial PsA, NCT02181673). Previous treatment with a biologic was not allowed. Patients were randomized to either receive Symponi Aria 2 mg/kg (N=241) or placebo (N=239) as a 30-minute intravenous infusion at Weeks 0, 4, 12 and 20. All patients on placebo received Symponi Aria at Week 24, Week 28 and every 8 weeks thereafter through Week 52. Patients in the Symponi Aria treatment group continued to receive Symponi Aria infusions at Week 28 and every 8 weeks through Week 52.

    Patients were allowed to continue stable doses of MTX, NSAIDs, and low dose oral corticosteroids (equivalent to ≤ 10 mg of prednisone per day) during the trial. The use of other DMARDs including cytotoxic agents or other biologics was prohibited. The primary endpoint was the percentage of patients achieving an ACR 20 response at Week 14.

    Clinical Response: Results showed that treatment with Symponi Aria ± MTX achieved the following ACR responses vs placebo, respectively:

    • ACR 20

      • Week 14: 75% vs 22% (difference from placebo, 53%; 95% CI, 46-61; P <.001)

      • Week 24: 77% vs 24% (difference from placebo, 53%; 95% CI, 45-60)

      •  

    • ACR 50

      • Week 14: 44% vs 6.3% (difference from placebo, 37%; 95% CI, 30-44)

      • Week 24: 54% vs 6.3% (difference from placebo, 47%; 95% CI, 40-54)

    • ACR 70

      • Week 14: 25% vs 2.1% (difference from placebo, 22%; 95% CI, 17-28)

      • Week 24: 33% vs 3.3% (difference from placebo, 29%; 95% CI, 23-36)

    At week 14, treatment with Symponi Aria ± MTX achieved the following mean changes in ACR components vs placebo ± MTX, respectively:

    • Number of swollen joints (0-66): 

      • Baseline: 14 vs 14

      • Week 14: -11 vs -2.9

    • Number of tender joints (0-68): 

      • Baseline: 25 vs 26

      • Week 14: -15 vs -4.2

    • Patient’s assessment of pain (0-100 mm): 

      • Baseline: 63 vs 64

      • Week 14: -31 vs -11

    • Patient global assessment (0-100 mm): 

      • Baseline: 65 vs 63

      • Week 14: -32 vs -11

    • Physician global assessment (0-100 mm): 

      • Baseline: 62 vs 64

      • Week 14: -39 vs -13

    • Health Assessment Questionnaire-Disability Index (HAQ-DI) score (0-3): 

      • Baseline: 1.3 vs 1.3

      • Week 14: -0.60 vs -0.13

    • hsCRP (mg/L): 

      • Baseline: 19 vs 20

      • Week 14: -16 vs -2.9

    Simponi Aria-treated patients also showed a significantly greater improvement in enthesitis, with a mean reduction of 1.8 as compared with a mean reduction in placebo-treated patients of 0.8 at Week 14. Patients with dactylitis at baseline were evaluated for mean improvement on a scale of 0-60. Simponi Aria-treated patients showed a significantly greater improvement, with a mean reduction of 7.8 compared with a mean reduction of 2.8 in placebo-treated patients at Week 14.

    Radiographic Response: In Trial PsA, structural joint damage was assessed radiographically and expressed as a change from baseline at Week 24 in total modified vdH-S score and its components, the erosion score and JSN score. 

    Simponi Aria inhibited the progression of structural joint damage with a -0.4 change in total modified vdH-S score compared with 2.0 change for placebo (difference from placebo, -2.3; 95% CI, -2.9, -1.7).

    At Week 24, 72% of patients treated with Simponi Aria had no progression of structural damage (change in the total modified vdH-S score ≤ 0), compared with 43% of patients treated with placebo.

    Physical Function and Responses: Improvement in physical function as assessed by the Health Assessment Questionnaire Disability Index (HAQ-DI) demonstrated that the proportion of patients who achieved clinically meaningful improvement of ≥ 0.3 in HAQ-DI score from baseline was greater in the Simponi Aria-treated group compared to placebo at Week 14 (69% vs 32%).

    Other Health Related Outcomes: General health status was assessed by the 36-item Short Form Health Survey (SF-36). In Trial PsA, patients receiving Simponi Aria achieved greater improvement from baseline compared with placebo in physical component summary, mental component summary scores and in all 8 domains of the SF-36.

    Fatigue was assessed by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) in Trial PsA. Treatment with Simponi Aria resulted in improvement in fatigue as measured by FACIT-F.

    Treatment of Pediatric Patients: The efficacy of Simponi Aria in pediatric patients with PsA is based on the pharmacokinetic exposure and extrapolation of the established efficacy of Simponi Aria in adult PsA patients in Trial PsA.

     

    Ankylosing Spondylitis

    The efficacy and safety of Simponi Aria were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial (Trial AS, NCT02186873) in 208 patients ≥ 18 years of age with active ankylosing spondylitis (AS) and inadequate response or intolerance to NSAIDs. Patients were randomized to receive either Simponi Aria 2 mg/kg (N=105) or placebo (N=103) as a 30-minute intravenous infusion at Weeks 0, 4 and 12. All patients on placebo received Simponi Aria at Week 16, Week 20 and every 8 weeks thereafter through Week 52.

    Patients were allowed to continue stable doses of concomitant MTX, SSZ, hydroxychloroquine (HCQ), low dose oral corticosteroids (equivalent to ≤ 10 mg of prednisone per day), and/or NSAIDs during the trial. The use of other DMARDs including cytotoxic agents or other biologics was prohibited. The primary endpoint was the percentage of patients achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.

    Clinical Response: In Trial AS, 73% of patients treated with Simponi Aria treatment achieved an ASAS 20 response at week 16 compared with 26% of patients treated with placebo (treatment difference, 47%; 95% CI, 35-59; P <.001). 

    Moreover, 48% of patients treated with Simponi Aria treatment achieved an ASAS 40 response at week 16 compared with 8.7% of patients treated with placebo (treatment difference, 39%; 95% CI, 28-50).

    At week 14, treatment with Symponi Aria achieved the following mean changes in ACR 20 components and other measures of disease activity vs placebo, respectively:

    • Patient global assessment of disease activity (0-100 mm): 

      • Baseline: 73 vs 71

      • Week 14: -34 vs -8.3

    • Total Back Pain (0-100 mm): 

      • Baseline: 73 vs 72

      • Week 14: -32 vs -12

    • Bath Ankylosing Spondylitis Functional Index (BASFI) (0-10): 

      • Baseline: 6.3 vs 6.1

      • Week 14: -2.4 vs -0.5

    • Inflammation (0-10):

      • Baseline: 7.3 vs 7.4

      • Week 14: -3.6 vs -1.1

    • BASDAI Score

      • Baseline: 7.1 vs 7.1

      • Week 14: -3.1 vs -1.1

    • Bath Ankylosing Spondylitis Metrology Index (BASMI):

      • Baseline: 5.0 vs 5.0

      • Week 14: -0.4 vs -0.1

    • hsCRP (mg/L)

      • Baseline: 20 vs 19

      • Week 14: -17 vs -2.3

    At Week 16, a greater percentage of patients treated with Simponi Aria achieved a low level of disease activity (<2 [on a scale of 0 to 10 cm] in all four ASAS domains) compared with patients treated with placebo (16.2% vs 3.9%).

    Other Health-Related Outcomes: General health status was assessed by the 36-item Short Form Health Survey (SF-36). In Trial AS, patients receiving Simponi Aria demonstrated greater improvement from baseline compared with placebo in physical component summary and mental component summary scores and in all 8 domains of the SF-36. 

    Simponi Aria-treated patients showed significant improvement compared with placebo-treated patients in health related quality of life as assessed by the Ankylosing Spondylitis Quality of Life questionnaire (ASQoL).

     

    Polyarticular Juvenile Idiopathic Arthritis (pJIA)

    The efficacy of Simponi Aria in pediatric patients with pJIA is based on the pharmacokinetic exposure and extrapolation of the established efficacy of Simponi Aria in RA patients. Efficacy of Simponi Aria was also assessed in a multicenter, open-label, single-arm study in 127 children (2 to < 18 years of age) with JIA with active polyarthritis despite treatment with MTX for at least 2 months (Trial pJIA, NCT02277444). All patients received Simponi Aria 80 mg/m2 as an intravenous infusion at Week 0, 4, and every 8 weeks through Week 52. Patients continued stable doses of MTX weekly through Week 28; after Week 28, changes in MTX dose were permitted. Efficacy was assessed as supportive endpoints through Week 52. The efficacy was generally consistent with responses in patients with RA.

    Simponi Aria Note

    Not Applicable

    Simponi Aria Patient Counseling

    Patient Counseling

    Infections 

    • May lower the ability of their immune system to fight infections. Instruct the patient of the importance of contacting their doctor if they develop any symptoms of infection, including tuberculosis, invasive fungal infections, and hepatitis B reactivation. 

    Malignancies

    • Counseled patients about the risk of lymphoma and other malignancies while receiving Simponi Aria. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

    Other Medical Conditions

    • Report any signs of new or worsening medical conditions such as congestive heart failure, demyelinating disorders, autoimmune diseases, liver disease, cytopenias, or psoriasis.

    Vaccinations

    • Avoid live vaccines because Simponi Aria may lower the ability of their immune system to fight infections. Inform pregnant patients receiving Simponi Aria that their infants should not receive live vaccines for 6 months following the last infusion of Simponi Aria during pregnancy. Advise patients and infants of women who received Simponi Aria during pregnancy to consult a physician before receiving any immunizations. 

    Cost Savings Program

    Simponi Aria Patient Support: https://www.simponiaria.com/savings-information

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