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Infliximab (Remicade, Inflectra, Renflexis, Avsola and Unbranded Infliximab)

Infliximab is a tumor necrosis factor (TNF) blocker that may be used and Medically Necessary for treatment of::
Crohn’s Disease:

reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.

Pediatric Crohn’s Disease: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Ulcerative Colitis: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Pediatric Ulcerative Colitis: reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Rheumatoid Arthritis in combination with methotrexate: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active disease.

Ankylosing Spondylitis: reducing signs and symptoms in patients with active disease.

Psoriatic Arthritis: reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function.

Plaque Psoriasis: treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

The use of infliximab may be considered medically necessary for the treatment of Behçet syndrome and Behçet syndrome uveitis when:

patient is 18 years of age or older AND
has had an inadequate response with conventional therapy (i.e., systemic corticosteroids or immunosuppressive agents) OR
has an intolerance or contraindication with conventional therapy OR
if with uveitis has previously received a biologic indicated for uveitis.

Infliximab is recommended for off-label use for the following indications:

Fistulizing CD in children aged 6 years or older
JIA with sacroiliitis, enthesitis, or uveitis
Noninfectious uveitis
Polyarticular and oligoarticular JIA
RA without methotrexate
Sarcoidosis
Systemic JIA

The use of infliximab is considered investigational for the following conditions:

systemic juvenile idiopathic arthritis;
rheumatic and autoimmune conditions potentially treatable with tumor necrosis factor a inhibitors:

sarcoidosis;
systemic sclerosis;
Sjögren syndrome;
Kawasaki disease;
Primary sclerosing cholangitis;

vasculitides potentially treatable with tumor necrosis factor α inhibitors:

giant cell arteritis/polymyalgia rheumatic;
granulomatosis with polyangiitis (Wegener granulomatosis);
polyarteritis nodosa;

nonrheumatic musculoskeletal conditions:

arthritis (other than rheumatoid arthritis and psoriatic arthritis);
sacroiliitis (not associated with ankylosing spondylitis or spondyloarthritis;
intra-articular injections;

rheumatic joint disease refractory to tumor necrosis factor α inhibitors.

Infliximab off-label use indications

Immune Checkpoint Inhibitor-Related Toxicities

Consider adding for the management of immunotherapy-related

myocarditis as a further intervention if no improvement within 24-48 hours of starting pulse-dose methylprednisolone
moderate (G2) and strongly consider for severe (G3-4) diarrhea or colitis
severe inflammatory arthritis as additional disease modifying anti-rheumatic therapy if symptoms do not improve within 1 week after starting high-dosecorticosteroids or if unable to taper corticosteroids by week 2
moderate or severe steroid-refractory myalgias or myositis (muscleweakness), or life-threatening steroid-refractory myositis
G1 -4 uveitis that is refractory to high-dose systemic corticosteroids (treatmentguided by ophthalmology)
moderate (G2) pneumonitis if no improvement after 48-72 hours ofcorticosteroids or severe (G3-4) pneumonitis if no improvement after 48 hoursof methylprednisolone
severe (G3) or life-threatening (G4) elevated serum creatinine/acute kidneyinjury if toxicity remains >G2 after 4-6 weeks of corticosteroids

Hematopoietic Cell Transplantation

For acute* graft-versus-host disease (GVHD) as additional therapy in conjunction with systemic corticosteroids following no response (steroid-refractory disease) to first-line therapy options *therapy for steroid-refractory acute GVHD is often used in conjunction with the original immunosuppressive agent.»

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