Table 3. Selected MS DMTs with baseline and routine monitoring information.
| Drug (brand name) | Class | Efficacy | Dose | Screening tests | Additional information | Associated references |
|---|---|---|---|---|---|---|
| Ocrelizumab (Ocrevus) | Anti-CD20 monoclonal antibody | High | 300 mg IV×2 doses 2 weeks apart, then 600 mg every 24 weeks | • Screening laboratory tests: CBC, CMP, immunoglobulins, Quantiferon Gold, hepatitis B surface antigen and antibody • Optional laboratory tests include HIV, syphilis, hepatitis C, VZV IgG, baseline B and T cells • Monitoring laboratory tests include CBC, CMP, immunoglobulins, and CD20 counts every 6 months |
• Premedication with Tylenol, Benadryl, and IV Solumedrol • Infusions take 4 hours. Rapid protocol (2 hours) can be administered after the first year • Live vaccines at least 4 weeks prior to start of drug therapy |
82 83 84 85 86 89 |
| Ofatumumab (Kesimpta) | Anti-CD20 monoclonal antibody | High | 20 mg SQ weekly on weeks 0, 1, 2, then 20 mg every 4 weeks starting in week 4 | Screening and monitoring laboratory tests same as for ocrelizumab | • Side-effect profile similar to that of ocrelizumab • No need for premedication. Patients can self-administer via home injection |
83 88 89 90 |
| Natalizumab (Tysabri) | α4β1-integrin binder | High | 300 mg IV once a month. Option for every 6 weeks after 24 weeks on therapy | CBC, CMP, and JCV index every 3–6 months | • Risk of PML in JCV negative=1:10,000; 1:1,000 for patients with low titer • Monitor for liver dysfunction |
91 92 93 94 |
| Alemtuzumab (Lemtrada) | Anti-CD52 monoclonal antibody | High | Year 1:5 days of 12 mg IV daily with steroids Year 2:3 days of 12 mg IV daily with steroids |
• Baseline: CBC, creatinine, LFTs, UA, urine protein-to-creatine ratio, TSH, skin examination • Monthly laboratory tests (CBC with differential, CMP, and UA) for 48 months after the last treatment course of Lemtrada • TSH every 3 months • Yearly skin examinations |
• Only needs to be performed yearly, but requires monthly laboratory tests that continue 4 years after administration • Up to 40% risk of secondary autoimmune thyroid disease • Rare risk of ITP (2%), serious infusion reactions, TB, HSV, glomerulonephritis, thyroid malignancy, skin cancer (melanoma), and lymphoproliferative disorders |
95 |
| Fingolimod (Gilenya) | s1p inhibitor | Medium to high | 0.5 mg PO daily | • Baseline: CBC, CMP, Quantiferon Gold, hepatitis B surface antigen and antibody • EKG and first-dose monitoring due to bradycardia • Baseline ophthalmological and dermatological examinations • CBC with differential, CMP every 6 months • Ophthalmology examination to screen for macular edema 3 months after starting drug and then yearly • Annual dermatological examination |
• 6-hour first dose monitoring • Risk of PML up to 1:8,000 • Associated with increased risk of cryptococcal meningitis • Other side effects: infections (11%), bradycardia (3%), headache (25%), nausea/vomiting/diarrhea (13%), and macular edema (1.5%) • Stop 2 months before pregnancy • Lymphopenia is expected on s1p-inhibitor therapy and is not a reason for discontinuation |
72 74 75 103 104 105 |
| Siponimod (Mayzent) | s1p inhibitor | Medium to high | Initial: 0.25 mg PO once daily on days 1 and 2; 0.5 mg on day 3; 0.75 mg on day 4; 1.25 mg on day 5 Maintenance: 2 mg once daily, beginning on day 6 |
• Baseline: CBC, CMP, Quantiferon Gold, hepatitis B surface antigen and antibody, CYP2C9*3/*3, EKG • CBC with differential, CMP every 6 months • First-dose 6-hour monitoring is recommended for patients with certain preexisting cardiac conditions, including sinus bradycardia (HR <55 bpm), firstor second-degree (Mobitz type 1) AV block, or a history of MI or heart failure |
• Requires genetics testing to rule out CYP2C9*3/*3 before initiation • Side effects: hypertension (13%), headache (15%), falling (11%), increased serum transaminases (≤11%), peripheral edema (8%), bradycardia (4%–6%), first-degree atrioventricular block (5%), nausea (7%), diarrhea (6%), lymphocytopenia (<5%), and macular edema (2% to <5%) • Does not require first-dose monitoring, ophthalmological or dermatological examinations due to fewer off-target effects |
106 |
| Ozanimod (Zeposia) | s1p inhibitor | Medium to high | Initial: 0.23 mg once daily on days 1–4, 0.46 mg on days 5–7, then 0.92 mg daily | • CBC with differential every 6 months, EKG, CMP every 6 months, Quantiferon Gold, and hepatitis B surface antigen and antibody | • Does not require first-dose monitoring, ophthalmological or dermatological examinations due to fewer off-target effects • Risk of hypertension and liver enzyme elevation potentially lower than for other s1p inhibitors |
107 |
| Cladribine (Mavenclad) | Adenosine nucleoside analog | Medium to high | 2 oral treatment courses, each approximately 5 days each and 1 year apart Total dose of 3.5 mg/kg (1.75 mg/kg per treatment course) |
• LFTs and CBC with differential prior to initiating treatment • Annual CBC with differential to monitor for lymphopenia while receiving treatment • Screen patients for latent infections; vaccinate VZV-antibody-negative patients prior to treatment • If lymphocytes <200 cells/mm3, administer antiherpes prophylaxis |
• Side effects: lymphopenia (21.6%), herpetic infections, and teratogenicity • Additional cladribine beyond 2 years associated with slightly increased malignancy risk (0.91 events per 100 patient-years) |
71 |
| Dimethyl fumarate (Tecfidera) | Fumarate | Medium | Initial: 120 mg PO BID then after 7 days increase to maintenance dose of 240 mg BID Take with food |
CBC with differential, LFTs every 6 months | • Side effects: flushing (40%), abdominal pain (18%), diarrhea (14%), and nausea (12%) • Lymphopenia occurs in 2%. Withhold medication when lymphocyte count <500 |
79 81 |
| INF β-1α (Avonex, Rebif, Plegridy) and INF beta-1b (Betaseron) | Immunomodulator | Low | CBC, CMP at 3 months, 6 months, and then yearly | • Flu-like symptoms, depression, and injection-site irritation | 59 60 | |
| Teriflunomide (Aubagio) | Pyrimidine synthesis inhibitor | Low | 14 mg PO daily | CBC, CMP, Quantiferon Gold, LFTs monthly for first 6 months | • Hair thinning (10%); avoid in patients with liver disease • Category X in pregnancy. Long half-life, can stay in body for 1 year; must use cholestyramine elimination protocol |
67 |
| GA (Copaxone or Glatopa) | Receptor decoy | Low | 20 mg SQ daily or 40 mg TID | No laboratory monitoring required | • Flushing, chest pain after injection, and lipoatrophy | 64 |
CBC, complete blood count; CMP, comprehensive metabolic panel; HSV, herpes simplex virus; IM, intramuscular; ITP, immune thrombocytopenia; IV, intravenous; JCV, John Cunningham virus; LFT, liver function tests; PML, progressive multifocal leukoencephalopathy; PO, per oral; SQ, subcutaneous; TB, tuberculosis; UA, urinalysis; VZV, varicella zoster virus.