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Golimumab

Editor: Mayur Parmar Updated: 6/3/2023 11:46:25 AM

Indications

Golimumab is classified as a human monoclonal antibody tumor necrosis factor-alpha (TNF-α) blocker indicated for the management of active rheumatoid arthritis (RA) with a moderate to severe disease course in sequence with methotrexate (MTX), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), and ulcerative colitis (UC) in adult subjects with a moderate to severe disease course that did not achieve an adequate response to previous therapy, or subjects requiring ongoing steroid treatment.[1][2] 

Golimumab's indication for PsA can be used as monotherapy or concomitantly with MTX. The agent has also received approval in 2020 for its use in active polyarticular juvenile idiopathic arthritis (pJIA) and PsA in subjects aged two years and older.[3]

FDA-Approved Use

  • Rheumatoid arthritis (active moderate to severe disease course) in combination with methotrexate in adult patients
  • Psoriatic arthritis (active disease) in adult patients
  • Ankylosing spondylitis (active disease) in adult patients[4]
  • Ulcerative colitis (moderate to severe disease course) in adult patients
  • Polyarticular juvenile idiopathic arthritis and psoriatic arthritis in pediatric patients two years and older[5]

Mechanism of Action

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Mechanism of Action

Golimumab is a human monoclonal antibody that exerts its effects by binding human TNF-α soluble and transmembrane structures and blocking its binding with the TNF-α receptors. The prevention further hinders the biological activity of TNF-α, a pro-inflammatory cytokine protein that plays a role in inflammation, autoimmunity, and malignancy.[6] Increased levels of TNF-α in the joints and synovium are associated with the pathophysiologic process resulting in articular inflammation in chronic inflammatory conditions such as RA, PsA, and AS.[7]

Administration

Golimumab is available as prefilled syringes in 50 mg and 100 mg dosage forms for subcutaneous injection and a 50 mg/4 mL (12.5 mg/mL) solution supplied in a single-dose vial for intravenous infusion. The entire volume of golimumab should be diluted with a 0.9% sodium chloride injection, USP for a cumulative volume of 100 mL. An amount equal to the whole quantity of golimumab can be withdrawn from a 100 mL infusion bag of 0.9% sodium chloride, USP, and gradually combined the total volume of golimumab solution to the 100 mL infusion bag. Any left-over solution in vials should be discarded.

Rheumatoid Arthritis

  • 2 mg/kg is administered as an intravenous infusion at week 0, week 4, then week 8. Treatment is continued every eight weeks thereafter. The intravenous infusion is gradually administered over a 30-minute duration.  
  • 50 mg administered as a subcutaneous injection every four weeks.

Psoriatic Arthritis

  • 2 mg/kg is administered as an intravenous infusion at week 0, week 4, then week 8. Treatment is continued every eight weeks thereafter. The intravenous infusion is gradually administered over a 30-minute duration.  
  • 50 mg administered as a subcutaneous injection every four weeks.

Active Ankylosing Spondylitis

  • 2 mg/kg is administered as an intravenous infusion at week 0, week 4, then week 8. Treatment is continued every eight weeks thereafter. The intravenous infusion is gradually administered over a 30-minute duration.  
  • 50 mg administered as a subcutaneous injection every four weeks.

Ulcerative Colitis

  • 200 mg is given as a subcutaneous injection during week 0 (initial dosage)
  • 100 mg is given as a subcutaneous injection during week 2, followed by 100 mg every four weeks

Polyarticular Juvenile Idiopathic Arthritis and Psoriatic Arthritis (pediatric patients: 2 years and older)

  • 80 mg/m^2 is administered as an intravenous infusion at week 0, week 4, then week 8. Treatment is continued every eight weeks thereafter. The intravenous infusion is gradually administered over a 30-minute duration.

Hypersensitivity reactions (angioedema, urticaria, anaphylaxis) may occur during the administration of golimumab infusion. Immediate discontinuation of golimumab and appropriate management should be initiated.

Adverse Effects

Adverse effects of severe infections and invasive fungal infections may also occur, and treatment should not be initiated during any active infections. Patients with hepatitis b virus (HBV) are at risk for HBV reactivation. Patients with underlying congestive heart failure (CHF) receiving golimumab may also have worsening CHF symptoms. New-onset CHF may also occur. Lupus-like syndrome and hypersensitivity reactions such as anaphylaxis may also transpire. Worsening or new-onset demyelinating disorders have also been reported.[8]

  • Upper respiratory tract infection (URTI): nasopharyngitis, pharyngitis, laryngitis, and rhinitis (13 to 16%)
  • Sinusitis (2%)
  • Bronchitis (2%)
  • Viral infections (4 to 5%)
  • Bronchitis (2 to 3%)
  • Injection site reaction: pain, redness, urticaria, induration, bruising, pruritus, irritation (3 to 6%)
  • Elevated liver enzymes: alanine aminotransferase (4%), aspartate aminotransferase (3%)
  • Hypertension (3%)
  • Dizziness (2%)
  • Paresthesia (2%)
  • Constipation (1%)
  • Pyrexia (2%)
  • Leukopenia (1%)
  • Superficial fungal infections (2%)

Contraindications

No labeled contraindications have been reported. Golimumab should not be administered concomitantly with a biologic class of disease-modifying antirheumatic drugs (DMARDs) or Janus kinase (Jak) inhibitors. The administration of live vaccines concurrently with golimumab is not recommended. The use of therapeutic infectious agents such as antibiotics and antiviral therapy with golimumab is also not advised.[7] 

Golimumab use in pregnancy may result in an increase of infections for up to 6 months in newborns. Infants exposed to golimumab in utero are advised not to receive any live vaccinations for up to 6 months following the mother's last golimumab treatment during pregnancy.[9]

Monitoring

Prior to initiating golimumab, a test for active or latent tuberculosis (TB) should be performed by tuberculin skin test (TST) or interferon-γ release assay (IGRA). Patients should also be routinely monitored throughout treatment for TB after starting therapy with golimumab. Subjects with latent TB should be treated prior to initiating golimumab. Patients should also receive a baseline complete blood count (CBC) and routinely thereafter. Patients with an active infection should not be started on golimumab. Monitoring for any bacterial, viral, fungal, or opportunistic infections while on treatment is also advised.

Liver function tests should also be checked regularly as elevated liver enzymes: alanine aminotransferase, aspartate aminotransferase are reported adverse effects. Patients with underlying CHF receiving golimumab should have regular check-ups for worsening CHF. Subjects with underlying HBV receiving therapy with golimumab should be assessed at baseline and regularly thereafter for HBV reactivation. In the event of viral reactivation, golimumab should be halted, and appropriate treatment should be initiated.[10]

Toxicity

Boxed Warnings

  • The use of golimumab can result in serious infections, which may further cause hospitalization or even death. Diseases such as bacterial sepsis, tuberculosis (TB), and fungal and opportunistic infections have been reported. Treatment with golimumab should be discontinued if any of these infections ensue.
  • Lymphoma and additional malignancies, which some have resulted in mortality, have also been reported with the use of TNF inhibitors in pediatric populations.
  • A TB test should be performed prior to initiating golimumab. If a positive test is positive for latent infection, TB treatment should be initiated before starting golimumab.
  • Patients receiving golimumab should be monitored for the development of active TB regardless of a negative initial test for latent TB.
  • Patients with HBV receiving treatment with golimumab should be monitored for some months after initiating therapy for HBV reactivation. In the event of a reactivation, golimumab should be stopped immediately, and anti-viral treatment should be initiated.[7][8]

Enhancing Healthcare Team Outcomes

Golimumab is a tumor necrosis factor-alpha inhibitor targeting the human TNF-α cytokine protein and further preventing binding with its receptors. The agent is FDA-approved for managing active moderate to severe rheumatoid arthritis in sequence with first-line therapy methotrexate, active psoriatic arthritis, active ankylosing spondylitis, and patients with moderate to severe ulcerative colitis unable to achieve an adequate response to previous therapy, or patients requiring ongoing treatment with steroid. Golimumab recently attained FDA approval in 2020 for its indication in the pediatric population on treating active polyarticular juvenile idiopathic arthritis and psoriatic arthritis in patients aged two years and above.

The care and management of inflammatory and autoimmune disease patients require care coordination from the interprofessional team of healthcare professionals. Immediate clinical examination and diagnosis can further result in efficient treatment plans, which can mitigate debilitating symptoms and further increase the quality of the patient's life. The interprofessional treatment team comprises a primary care physician (PCP), a rheumatologist, a gastroenterologist, mid-level practitioners, nurses, a physical therapist (PT), and a pharmacist.

Continuous interaction between the prescribing specialist and PCP should be maintained to be up to date with their patient's care. The treatment team should also be regularly updated with the latest guidelines on their patient's disease management. The interprofessional team should thoroughly educate and counsel their patients on their disease and management with golimumab. Patients should be aware of any potential adverse effects that may occur and be advised to report any new onset unsuspected symptoms. Golimumab administration should be done in a health care setting where the interprofessional care team is fully equipped for any immediate adverse effects such as hypersensitivity reactions (hives, pruritus, dyspnea, nausea, angioedema, urticaria, anaphylaxis). In the event of any severe events such as anaphylaxis, the treatment should be immediately stopped, and appropriate management should be initiated.

While treating patients with golimumab, the healthcare team should monitor the patients' complete blood count, liver enzymes, and TB test before initiating the treatment and routinely afterward. TB screening with a tuberculin skin test (TST) or interferon-γ release assay (IGRA) should be performed on all patients. Patients who present a positive TB test should receive management for TB before initiating treatment with golimumab. Patients with a history of HBV and who receive golimumab should routinely be monitored for HBV reactivation and discontinue therapy if reactivation does ensue. The treatment team should discuss the boxed warnings of golimumab and all potential benefits and risks of treatment with all patients planning to start therapy.

Patients should be advised of the boxed, labeled warning of increased risk of potentially severe infections and malignancy. Patients are to immediately report any new onset constitution symptoms indicative of severe infections to their PCP to prevent complications, hospitalization, and potential mortality. Intercommunication is vital amongst the interprofessional team while treating with golimumab as it can further increase medication compliance, decrease potential adverse effects, improve disease course and quality of life.[11]

References


[1]

Hayashi T, [Golimumab]. Nihon rinsho. Japanese journal of clinical medicine. 2013 Jul;     [PubMed PMID: 23961671]


[2]

Cunningham G,Samaan MA,Irving PM, Golimumab in the treatment of ulcerative colitis. Therapeutic advances in gastroenterology. 2019;     [PubMed PMID: 30728858]

Level 3 (low-level) evidence

[3]

Lanz S,Seidel G,Skrabl-Baumgartner A, Golimumab in juvenile idiopathic arthritis-associated uveitis unresponsive to Adalimumab. Pediatric rheumatology online journal. 2021 Aug 21;     [PubMed PMID: 34419092]


[4]

Rossini M,Viapiana O,Orsolini G,Fracassi E,Idolazzi L,Gatti D,Adami S,Govoni M, Why golimumab in the treatment of psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis? Reumatismo. 2015 Mar 31;     [PubMed PMID: 25829189]


[5]

Campas-Moya C, Golimumab: A novel anti-TNF-alpha human monoclonal antibody for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Drugs of today (Barcelona, Spain : 1998). 2010 Jan;     [PubMed PMID: 20200692]

Level 3 (low-level) evidence

[6]

Padda IS,Bhatt R,Rehman O,Parmar M, Biosimilars Use In Medicine For Inflammatory Diseases StatPearls. 2021 Jan;     [PubMed PMID: 34662086]


[7]

Gerriets V,Bansal P,Goyal A,Khaddour K, Tumor Necrosis Factor Inhibitors StatPearls. 2021 Jan;     [PubMed PMID: 29494032]


[8]

Godfrey MS,Friedman LN, Tuberculosis and Biologic Therapies: Anti-Tumor Necrosis Factor-α and Beyond. Clinics in chest medicine. 2019 Dec;     [PubMed PMID: 31731980]


[9]

Golimumab Drugs and Lactation Database (LactMed). 2006;     [PubMed PMID: 30000713]


[10]

Lasa JS,Olivera PA,Danese S,Peyrin-Biroulet L, Efficacy and safety of biologics and small molecule drugs for patients with moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis. The lancet. Gastroenterology & hepatology. 2021 Nov 29     [PubMed PMID: 34856198]

Level 1 (high-level) evidence

[11]

Melo AT,Campanilho-Marques R,Fonseca JE, Golimumab (anti-TNF monoclonal antibody): where we stand today. Human vaccines     [PubMed PMID: 33369527]