Simponi Aria (Golimumab), the Only Fully Human Anti–TNF-α Infused Therapy, Now Approved for Active Psoriatic Arthritis and for Active Ankylosing Spondylitis

March 2018, Vol 11, Ninth Annual Payers' Guide - FDA Approvals, News & Updates
Lisa A. Raedler, PhD, RPh
Medical Writer

Ankylosing spondylitis, a form of spondyloarthritis, is an inflammatory disease that often affects the sacroiliac, the spine and lower back, the entheses (where tendons and ligaments connect to bone), the cartilage between the ribs and breastbone, and the hip and shoulder joints.1 The disease can also lead to fusing of the vertebrae in the spine and inflammation in other parts of the body, including the eyes.1 In the United States, spondyloarthritis affects between 646,200 and 1.6 million individuals.2

Psoriatic arthritis is an inflammatory disease characterized by stiffness, swelling, and pain that can affect any joint, including fingers and toes. The disease is often accompanied by skin and nail psoriasis. An estimated 2.4 million people in the United States have psoriatic arthritis, and approximately 33% of patients with psoriasis eventually have psoriatic arthritis.3

Patients with psoriatic arthritis or ankylosing spondylitis are prone to have chronic pain and physical limitations that substantially affect their quality of life. The therapeutic goals for these conditions include reducing inflammation, alleviating pain and stiffness, preventing spine and joint damage, and minimizing complications.1,4

Timely diagnosis and treatment of psoriatic arthritis or ankylosing spondylitis are vital for reducing inflammation and mitigating joint damage.3

Simponi Aria Approved for Psoriatic Arthritis and for Ankylosing Spondylitis

On October 20, 2017, the US Food and Drug Administration (FDA) approved golimumab (Simponi Aria; Janssen) for the treatment of adults with active psoriatic arthritis or with active ankylosing spondylitis.5 Golimumab, the only fully human anti–tumor necrosis factor (TNF)-α therapy, is administered via a 30-minute intravenous (IV) infusion.5

Golimumab as an IV infusion was first FDA approved in 2013, in combination with methotrexate, for the treatment of adults with moderately to severely active rheumatoid arthritis.6 A once-monthly subcutaneous injection of golimumab was initially approved for rheumatoid arthritis in 2009.

Mechanism of Action

Elevated levels of TNF-α in the blood, synovium, and joints play a role in the pathophysiology of psoriatic arthritis, ankylosing spondylitis, and other chronic inflammatory diseases.7 Golimumab is a human monoclonal antibody that binds to and inhibits the biological activity of TNF-α, a cytokine protein that mediates the articular inflammation that is implicated in inflammatory disease.7

Dosing and Administration

The recommended dosage of golimumab is 2 mg/kg administered via an IV infusion for 30 minutes at weeks 0 and 4, and subsequently every 8 weeks.7

Golimumab is available as a 50-mg/4-mL (12.5 mg/mL) solution in a single-use vial.7

Pivotal Clinical Trials
Psoriatic Arthritis

The safety and efficacy of golimumab for psoriatic arthritis were assessed in the phase 3, randomized, double-blind, placebo-controlled GO-VIBRANT clinical trial, which included 480 adults with active psoriatic arthritis despite treatment with a disease-modifying antirheumatic drug (DMARD) or a nonsteroidal anti-inflammatory drug (NSAID).8 Eligible patients could continue to receive stable doses of methotrexate, NSAIDs, and low-dose corticosteroids during the study, but the use of other DMARDs or other biologic drugs was not allowed. Patients had a diagnosis of psoriatic arthritis for a minimum of 6 months and had symptoms of active disease.8

The primary end point was the percentage of patients who achieved an improvement of ≥20% from baseline across several sign or symptom measures according to the American College of Rheumatology (ACR20) criteria at week 14. Patients who received golimumab achieved significantly greater improvement versus placebo (53% difference) in the signs and symptoms of psoriatic arthritis at week 14, and these results were maintained at week 24 (Table 1).7,8

Table 1

The ACR20 improvements with golimumab therapy were similar in patients who received or did not receive concomitant methotrexate. Greater improvements in ACR50 response and ACR70 response were also achieved with golimumab versus placebo.8 Furthermore, this study demonstrated that patients who received golimumab had less radiographic progression of joint damage compared with placebo at week 24.8

Ankylosing Spondylitis

Golimumab was evaluated in 208 adults with active ankylosing spondylitis who had an inadequate response or intolerance to NSAIDs in the randomized, double-blind, placebo-controlled phase 3 GO-ALIVE clinical trial. Eligible patients had a definite diagnosis of ankylosing spondylitis for ≥3 months and symptoms of active disease.9

The primary efficacy measure was the percentage of patients who achieved a 20% improvement across specific measures assessing overall function, pain, and inflammation, according to the Assessment in Ankylosing Spondylitis (ASAS20) response criteria at week 16.

Golimumab demonstrated a significant improvement versus placebo (47% difference) in the signs and symptoms of ankylosing spondylitis, as measured by the percentage of ASAS20 responders (Table 2).7,9

Table 2

In addition, a higher percentage of patients who received golimumab had a low level of disease activity across 4 measures compared with placebo at week 16.9

Adverse Reactions

The most common (incidence ≥3%) adverse reactions associated with golimumab IV injection are upper respiratory tract infection, increased alanine aminotransferase levels, viral infection, increased aspartate aminotransferase levels, decreased neutrophil count, bronchitis, hypertension, and rash.7 The most serious adverse reactions were serious infections and malignancies.7

Golimumab has no contraindications.7

Drug Interactions

For the treatment of patients with psoriatic arthritis or ankylosing spondylitis, golimumab can be used with or without methotrexate.7

Because of the potential for an increased risk for infection, golimumab should not be combined with anakinra (Kineret) or abatacept (Orencia), or used concomitantly with biologic drugs that treat psoriatic arthritis, ankylosing spondylitis, or rheumatoid arthritis.7

Golimumab should not be given concurrently with live vaccines or with therapeutic infectious agents.7

When the use of golimumab is initiated or discontinued in patients receiving a cytochrome P450 substrate with a narrow therapeutic index, the effect or drug concentrations should be monitored, and drug doses may need to be adjusted accordingly.7

Use in Specific Populations

The safety and efficacy of golimumab have not been established in patients aged ≤18 years or in those aged ≥65 years. Children, adolescents, and older adults who receive TNF blockers have an increased risk for malignancies.6,7

Warnings and Precautions

Golimumab was approved with a boxed warning about the risk for serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal, and other opportunistic infections. Golimumab use should be discontinued if the patient has a serious infection or sepsis. Patients should be tested for latent tuberculosis, and those who test positive for latent tuberculosis should be treated for tuberculosis before starting golimu­mab therapy. All patients should be monitored for active tuberculosis during treatment with golimumab.7

The boxed warning also cautions about the risk for lymphoma and other malignancies, some fatal, in children and adolescent patients, associated with TNF inhibitors, including golimumab.7

Golimumab therapy should not be initiated during an active infection. Empiric antifungal therapy should be considered for patients with a systemic illness during golimumab therapy.7

Patients who are hepatitis B carriers should be monitored during and several months after treatment with golimumab. If hepatitis B reactivation occurs, golimu­mab should be discontinued and antiviral therapy should be initiated.7

Golimumab therapy can exacerbate or lead to a new onset of demyelinating disorders.7

Although rare, the use of TNF blockers, including golimumab, may result in lupus-like syndrome. Golimumab should be discontinued if symptoms indicative of lupus-like syndrome develop.7

Serious hypersensitivity reactions have been reported after the administration of golimumab; if a serious allergic reaction or anaphylaxis occurs, golimumab should be discontinued immediately.7

Cytopenias have been reported in patients who received golimumab, including pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia. Caution should be exercised when using TNF blockers, including golimumab, in patients with cytopenias or with a history of cytopenias.7

Conclusion

The FDA approval of 2 new indications for golimu­mab IV infusion provides a new treatment option for appropriate patients with psoriatic arthritis or ankylosing spondylitis. In clinical trials, golimumab, a fully human TNF-α blocker, demonstrated reduced joint symptoms and structural damage compared with placebo in patients with psoriatic arthritis, as well as reduced symptoms and disease activity in patients with ankylosing spondylitis.

Golimumab may provide certain patients the option of an alternative treatment schedule (at week 0 and 4, then every 8 weeks) and administration by a healthcare provider.

References
1. Mayo Clinic. Ankylosing spondylitis. www.mayoclinic.org/diseases-conditions/ankylosing-spondylitis/symptoms-causes/syc-20354808. Accessed February 1, 2018.
2. Reveille JD. Epidemiology of spondyloarthritis in North America. Am J Med Sci. 2011;341:284-286.
3. National Psoriasis Foundation. What is psoriatic arthritis? June 2017. www.psoriasis.org/sites/default/files/psoriatic_arthritis_fact_sheet_1.pdf. Accessed February 3, 2018.
4. Mayo Clinic. Psoriatic arthritis. www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/diagnosis-treatment/drc-20354081. Accessed February 5, 2018.
5. Johnson & Johnson. Janssen receives two U.S. FDA approvals for Simponi Aria (golimumab) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. October 20, 2017. www.jnj.com/media-center/press-releases/janssen-receives-two-us-fda-approvals-for-simponi-aria-golimumab-­for-the-treatment-of-adults-with-active-psoriatic-arthritis-or-active-ankylosing-­spondylitis. Accessed February 1, 2018.
6. Johnson & Johnson. Simponi Aria (golimumab) for infusion receives FDA approval for treatment of moderately to severely active rheumatoid arthritis. July 18, 2013. www.jnj.com/media-center/press-releases/simponi-aria-golimumab-­for-infusion-receives-fda-approval-for-treatment-of-moderately-to-severely-­active-rheumatoid-arthritis. Accessed March 5, 2018.
7. Simponi Aria (golimumab) injection [prescribing information]. Horsham, PA: Janssen Biotech; February 2018.
8. Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol. 2017;69:2151-2161.
9. Deodhar A, Reveille JD, Harrison DD, et al. Safety and efficacy of golimu­mab administered intravenously in adults with ankylosing spondylitis: results through week 28 of the GO-ALIVE study. J Rheumatol. 2018;45:1-8. Erratum in: J Rheumatol. 2018;45:291.

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