How are TNF inhibitors supplied and used for their FDA approved indications in rheumatic diseases

How are TNF inhibitors supplied and used for their FDA approved indications in rheumatic diseases?

ETN (Enbrel).

  • • Available formulations: single use 25-mg and 50-mg prefilled syringes; single use 50-mg SureClick autoinjector; single use 50-mg prefilled cartridge (Enbrel Mini) for use with reusable AutoTouch autoinjector; single use vial with 25 mg of lyophilized powder for reconstitution. Should be refrigerated but can be stable for up to 2 weeks at room temperature.
  • • Adult dosage: RA, PsA, AS: 25 mg subcutaneously (SC) twice a week or 50 mg SC once a week.
  • • Pediatric dosage: JIA (>138 lbs) 50 mg SC once a week; JIA (<138 lbs, age >2 years) 0.8 mg/kg SC once a week.
  • • In RA, typically used in conjunction with MTX or another conventional synthetic disease-modifying antirheumatic drug (csDMARD). Not effective for uveitis in spondyloarthropathies. Should not be used if a patient with AS has uveitis or inflammatory bowel disease (IBD).

INF (Remicade).

  • • Available formulations: single-use vials with 100 mg of lyophilized powder for reconstitution.
  • • RA dose: loading dose 3 mg/kg intravenous (IV) at weeks 0, 2, and 6, and then every 8 weeks. Dose can be increased as high as 5–10 mg/kg every 4 to 8 weeks.
  • • PsA, AS dose: loading dose 5 mg/kg IV at weeks 0, 2, and 6; then every 8 weeks for PsA and every 6 weeks for AS. Dose can be increased as high as 5 to 10 mg/kg every 4 weeks.
  • • Initial infusion takes 2 hours. If tolerated, subsequent infusions can be shortened.
  • • In RA, typically used in conjunction with MTX or other synthetic DMARD to decrease development of human antichimeric antibodies (HACAs), which can neutralize/increase clearance of INF and/or cause infusion reactions. Concomitant DMARD (MTX) use less important for spondyloarthropathies because HACAs are less likely to occur.

Pearl: if a patient is not responding initially, increasing the frequency of infliximab infusions is more efficacious than increasing the dose. Try not to increase dose higher than 5 mg/kg every 4 weeks because of infection and malignancy concerns.

  • ADA (Humira).
  • • Available formulations: single use 40-mg prefilled syringe; single use 40-mg autoinjector pen. There is a citrate-free option for 20-mg (pediatric) prefilled syringe as well as citrate-free option for 40-mg prefilled syringe and autoinjector pen. Citrate-free formulations sting less when injected.
  • • Adult dosage: RA, PsA, AS: 40 mg SC every other week.
  • • Adult dosage: uveitis: initial dose 80 mg, then 40 mg every other week starting 1 week after initial dose.
  • • Pediatric dosage: JIA (>66 lbs) 40 mg SC every other week; JIA (<66 lbs) 20 mg every other week.
  • • Although approved for use as monotherapy, ADA works better in association with MTX in RA. Some patients who do not respond to every other week dosing may respond to weekly dosing, although this is unusual and expensive.
  • Golimumab (Simponi and Simponi Aria).
  • • Available formulation: 50-mg and 100-mg single-use prefilled syringes or SmartJect autoinjectors; single-use vials (50 mg/4 mL) for IV use.
  • • Dosage: Simponi: RA, PsA, AS: 50 mg SC once a month. Simponi Aria: an IV formulation (2 mg/kg infused over 30 minutes at 0, 4, and then every 8 weeks).
  • • Although SC formulation is prescribed as a once a month dose, some patients do not get a full month of benefit.
  • Certolizumab pegol (Cimzia).
  • • Available formulation: single use 200-mg prefilled syringe with specially designed grip. There is also a 200 mg/vial lyophilized formulation that can be reconstituted and administered in physician’s office by a healthcare professional (this makes it eligible for Medicare part B insurance coverage).
  • • Dosage: RA, PsA, AS: loading dose 400 mg (two syringes) SC at weeks 0, 2, and 4; then 200 mg every 2 weeks.
  • • Owing to lack of functional Fc fragment, may be less injection site reactions and safer during pregnancy (does not cross placenta).
  • Other diseases anti-TNF-α inhibitors used in:
    • FDA-approved indications: psoriasis (ETN, INF, ADA), Crohn’s disease (INF, ADA, certolizumab), ulcerative colitis (INF, ADA, golimumab), hidradenitis suppurativa (ADA).
    • Off-label use: sarcoidosis, Takayasu’s arteritis, Behćet’s disease, pyoderma gangrenosum, reactive arthritis, adult-onset Still’s disease, others.
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