Table 4.

Initial Visit:

History and Physical

·        History of CHF?

·        History of malignancy or serious infections (hepatitis, TB, HIV, other)?

·        History or family history of multiple sclerosis?

o    History of other neurological disease including seizure disorders?

·        Total body skin exam for skin cancer

·        Check for HSM, cervical/axillary/inguinal lymphadenopathy

·        For Remicade - History of COPD and smoking?

·        History of diabetes?

·        Have you lived in Southwest (risk of coccidiomycosis) or Southeast – Ohio and Mississippi River Valleys (risk of histoplasmosis or blastomycosis)?

·        Travel to area endemic for TB?

·        Live vaccine within past month – you or household member?

·        Medications:  Anakinra; cyclosporine; abatacept; natalizumab; other anti-TNF agents; rituximab; methotrexate; corticosteroids; cyclophosphamide (increased risk of solid malignancies in Wegener’s granulomatosis); warfarin (levels can be decreased by anti-TNF agents)

·        Major surgery in next month?

·        Active infection?  Hold dose for infection or sepsis

·        Latex allergy?

·        History Wegener’s granulomatosis AND cyclophosphamide? (risk of malignancy)

·        For Enbrel - History of alcoholism? (increased mortality in alcoholic hepatitis)

Labs

·        CBC, CMP

·        TB test (for PPD, consider >5mm as positive)

·        Hepatitis B screen:  Hepatitis B sAg, Hepatitis B sAb, Hepatitis B cAb

·        Influenza vaccine (if flu season)

·        Baseline ANA (optional)

·        HIV (optional) – especially with erythrodermic psoriasis

·        Cardiovascular risk panel:  CRP, homocysteine, HbA1C, lipid profile (if screening for psoriasis) (optional)

·        Pneumovax (optional)

Counseling/Other

·        First injection under supervision of health care professional and instruction of proper disposal of needles

·        Can worsen existing malignancies

·        Malignancy:  more frequently observed malignancies were lymphoma, non-melanoma skin cancer, and acute and chronic leukemia; lymphoma and other malignancies in children and adolescents including Hodgkin's and non-Hodgkin's lymphoma; 

o    for Humira, malignancies seen more than in controls; lymphoma more than in general population

o    for Remicade and Cimzia, non-melanoma skin cancer with prior phototherapy

o    for Remicade, breast and colorectal cancers were observed in trials

o    for Remicade, if h/o COPD and smoking, risk of lung or head and neck malignancy

o    for Remicade, hepatosplenic T-cell lymphoma - all in Crohn's or ulcerative colitis, mostly adolescent or young adult males AND azathioprine or 6-mercaptopurine at or prior to diagnosis (although rheumatologists frequently use this combination)

·        Risk of reactivation of latent TB –

o    risk is less with Enbrel than with TNF-blocking monoclonal antibodies

·        Serious, sometimes fatal, infection (especially with methotrexate or corticosteroids):  bacterial (including sepsis), mycobacterial, invasive fungal, viral, and opportunistic infections, such as tuberculosis (including reactivation), histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis, listeriosis 

·        Exacerbation or new onset of demyelinating disease, e.g., multiple sclerosis, seizure disorder

o    Rare cases of optic neuritis, seizure, CNS manifestations of systemic vasculitis, peripheral demyelinating disorders such as Guillain-Barre syndrome;  Caution with pre-existing demyelinating or seizure disorders

·        Can worsen moderate to severe heart failure or cause new-onset heart failure

·        May lower incidence of coronary artery disease (a benefit)

·        Injection site reaction

·        Anaphylaxis from injection (e.g., angioedema; bronchospasm; hypotension)

·        Lupus-like syndrome

·        Reactivation of hepatitis B

·        Hepatotoxicity - acute liver failure, jaundice, hepatitis, cholestasis, autoimmune hepatitis; increased mortality with alcoholic hepatitis at six months

·        Incidence of elevated liver enzymes and liver complications is somewhat higher with Remicade than with other TNF-alpha inhibitors⁴.

·        Cytopenias:  pancytopenia, aplastic anemia, leucopenia, thrombocytopenia

·        Avoid live vaccines – self and household members

·        Pediatric Patients:  Up to date on vaccines before starting?

·        Needle cap of the prefilled syringe contains a latex derivative

·        Formation of anti-Humira antibodies, less with weekly dosing, less with concomitant methotrexate, that can cause decreased efficacy over time

·        For Enbrel - If you have diabetes, there is a risk for hypoglycemia and a higher chance for infection when serum glucose is poorly controlled

·        For Simponi and Remicade - New-onset or worsening psoriasis

·        For Cimzia - Erroneously elevated aPPT tests

·        For Cimzia - Intestinal obstruction (with Crohn's patients)

Follow-up Visit:

History and Physical

·        Every six months:  Total body skin exam for skin cancer

·        Every six months:  Check for HSM, cervical/axillary/inguinal lymphadenopathy

·        Any new infection – hold dose for active infection or sepsis

·        Any signs of heart failure

·        Major surgery in next month?

·        Is there sustained clinical efficacy in the treatment interval?  Skin?  Joints?

·        Any live vaccines in past month?

·        Any household members getting live vaccine?

·        Other interval history

Labs

·        Every three months for first two follow-up visits, then every six months:  CBC, CMP

·        Every year:  TB test (consider induration of >5mm as positive)

·        Influenza vaccine annually (in flu season)

·        In HBV carriers, check liver panel for laboratory signs of hepatitis B reactivation

·        ANA and anti-ds-DNA (if lupus-like symptoms)