Multiple sclerosis Betaseron protocol and monitoring
Interferon beta-1b for MS is given subcutaneously every other day, with dose titration. Common side effects include flu-like symptoms, liver dysfunction, and blood cell changes. Monitoring involves regular blood tests, liver function, and neutralizing antibodies. Adjust or discontinue for severe side effects or pregnancy.
Interferon Beta-1a (Avonex) Treatment for Multiple Sclerosis
Dosage & Titration Schedule:
Interferon beta-1b is administered at 0.25 mg (1 mL) every other day subcutaneously by self-injection:
Schedule for Dose Titration in relapsing remitting MS:
Days 7, 9, 11: 0.125 mg. Days 13, 15, 17: 0.1875 mg. Days ≥ 19: 0.250 mg
In secondary progressive MS, patients could be initiated with half the dose (0.125 mg SC every other day) for a period of 2 weeks prior to escalating to the recommended dose of 0.25mg SC every other day.
Side Effects:
Common side effects of interferon beta (INFB) therapy include injection site reactions, headache, flu like symptoms. Also, there is a high prevalence of asymptomatic, mild liver dysfunction (transaminitis) associated with IFNB therapy. Leukoneutropenia and anemia can also occur. Vomiting and diarrhae is common with INFB. Finally, rare cases of thrombotic microangiopathy have been linked to the use of IFNB therapy. INFB is contraindicated in patients with depressive disorders or those with history of seizures. (1, 2)
Monitoring:
Before Initiation of Therapy:
CBC, bilirubin, liver enzymes, TSH
HBsAg, anti-HBc, anti-HBs, Hepatits C, HIV, VZV serology
Vaccination status verified and updated,
Negative pregnancy test and counsel with regards to contraception
Monitoring During therapy :
CBC, Liver enzymes, bilirubin every month for 6months then then every 6 months
TSH every 6months
Monitor for neutralizing antibodies after 1st year including neutralizing antibodies (NAbs) and myxovirus resistance protein A (MxA) are investigational. The development of such antibodies can limit the effectiveness of INFB.
Premedication for Flu-like Symptoms with analgesics and/or antipyretics on treatment days to ameliorate flu-like symptoms.
If leukopenia develops or transaminases three times above normal then, it is advisable to decrease the IFNB dose by 50% or consider switching to another DMT if indicated.
Discontinuation Criteria:
ALT over 5times above normal level,
Severe leukopenia or pancytopenia, severe thrombocytopenia,
Seizure,
Pregnancy, or
If Nabs +ve .
(3, 4, 5, 6, 7)
References
1-Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: The EVIDENCE Trial. Neurology 2002; 59:1496.
2-O’Connor P, Filippi M, Arnason B, Comi G, Cook S, Goodin D, Hartung HP, Jeffery D, Kappos L, Boateng F. 250 μg or 500 μg interferon beta-1b versus
20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. The Lancet Neurology. 2009;8:889–897.
3-Oh J, Calabresi PA. Emerging injectable therapies for multiple sclerosis. Lancet Neurol 2013; 12:1115.
4-Feinstein A, O’Connor P, Feinstein K. Multiple sclerosis, interferon beta- 1b and depression. J Neurol. 2002;249:815–820.
5-Bertolotto A, Gilli F, Sala A, et al. Persistent neutralizing antibodies abolish the interferon beta bioavailability in MS patients. Neurology 2003; 60:634.
6-Goodin DS, Frohman EM, Hurwitz B, et al. Neutralizing antibodies to interferon beta: assessment of their clinical and radiographic impact: an evidence report: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2007; 68:977.
7-Kasper LH, Reder AT. Immunomodulatory activity of interferon-beta. Ann Clin Transl Neurol 2014; 1:622.
