NOTE: The discussion of safety / adverse effects herein focusses on key topics, and is NOT exhaustive.  Please consult the official product monograph. 

MECHANISM OF ACTION

  • Golimumab is a human monoclonal antibody that binds to Tumor Necrosis Factor alpha (TNF-alpha), thereby inhibiting the binding to TNFα receptors and subsequent generation of inflammatory cytokines.

INDICATIONS

  • Rheumatoid arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Ulcerative Colitis (UC)

ADULT DOSING

  • RA, PsA, AS
    • SubQ: 50 mg once a month (most common route of administration)
    • IV: 2 mg/kg at weeks 0, 4, and then every 8 weeks thereafter
  •  UC
    • SubQ: 200 mg SubQ at week 0, then 100 mg at week 2, followed by maintenance therapy of 100 mg every 4 weeks

DOSE ADJUSTMENT

 Hepatic Impairment: No dose adjustments provided in product monograph

 Renal Impairment: No dose adjustments provided in product monograph

SCREENING PRIOR TO STARTING THERAPY

  •  Screening for Latent Tuberculosis: CXR, TB skin test.
    •  Patients with Latent TB (skin test ≥ 5 mm, negative CXR) must receive TB prophylaxis.  Adalimumab can be started one month after prophylaxis is started.
    •  If TB skin test is thought to be false negative (eg. high endemic risk) or false positive (eg. BCG vaccine), IGRA should be performed.
  •  Hepatitis screening: Hep B sAg, Hep B cAb, Hep C Ab

VACCINATION

Patients with chronic inflammatory / rheumatic disease have an increased risk of infection.  Vaccinations should be considered at earlier ages than that prescribed for the general population.  Ideally, the following vaccines should be considered in patients prior to starting biologics, especially patients over 50.  However, depending on disease severity, one may need to proceed with biologic therapy and vaccinate along the way (most frequent scenario in clinical practice).  Data suggests reduced vaccine response (antibody titres) while on some DMARDS / Biologics, but this has not been shown to result in increased risk of infection.

  • Pneumonia: Prevnar 13, Pneumovax (given two months apart in this order).  If Pneumovax was received first, wait one year before giving Prevnar 13.
  • Shingles: Shingrix (two doses given 2-6 months apart; biologic can be started 2 weeks after the first dose).  Shingrix is preferred over the (older) live attenuated Zostavax vaccine.  If Zostavax is used, it must be given at least 2 weeks prior to starting biologics.
  • Annual flu vaccine

MONITORING

  •  Patients with rheumatic diseases on biologics are typically re-assessed clinically every 3-6 months, with investigations performed as clinically indicated.

WHEN TO AVOID

  •  Golimumab should be avoided in patients with active infection, active malignancy, hypersensitivity to golimumab / components.

SIDE EFFECTS AND ADVERSE REACTIONS

  • Infection: the risk of infection is considered to be very low, but serious infections have been reported in patients on biologic therapy.  When considering therapy, this has to be balanced against the increased risk of infection caused by active rheumatic / inflammatory disease.  Risk of infection is also confounded by use of concomitant DMARDS and prednisone.  Advise patients with symptoms of infection to hold the biologic, seek medical attention,and do not resume until one week after recovery.
  • Reactivation of Latent TB (see above), Hepatis B reactivation
  • Malignancy: Except for a 2-3 fold increase in the risk of skin cancer (melanoma and non-melanoma), data suggests that there is no increase in the risk of solid tumours with anti-TNF biologics.  Registry data suggests that the risk of lymphoma is driven by the underlying disease, and not by biologic medications.
  • Rare reports of demyelinating disease, autoimmune (lupus-like) diseases, interstitial lung disease, congestive heart failure (especially patients with preceding class III/IV heart failure) have been reported with anti-TNF therapy.

PREGNANCY

  • Emerging evidence suggests that Golimumab is safe in pregnancy, and current practice is to continue it throughout pregnancy.  In general, the risk of untreated rheumatic disease to the developing fetus and to maternal health is considered to be greater than the risk of Golimumab itself.
  • Golimumab crosses the placenta.  Use during the 3rd trimester can be associated with immunosuppression in the newborn for the first 3 months.  Live attenuated vaccines must therefore be avoided in the newborn for the first 6 months.

LACTATION

  • It is not known if golimumab is present in breast milk. However, anti-TNF biologics are considered compatible with breastfeeding