A Review Of Clinical Efficacy And Experience Of IFN-β1b In19Patients With Relapsing-remitting Multiple Sclerosis

Multiple sclerosis(MS)is the most common demyelinating disease of the central nervesystem in young adults. Clinically, MS presents with four relatively distinguishablepatters and relapse-remitting MS(RRMS)is the most common phenotype. Each relapsemay leave the patient with some residual disability which slowly accumulates, leading topermanent disability, imposing a heavy burden on individuals, families, communities andcountries. Untill now, MS remains incurable, treatment mainly consisting of acute attacksand maintain therapy. The standard of care for the treatment of an acute attack associatedwith MS is high dose intravenous methylprednisolone, it would shorten the duration ofacute stage，promote the recovery of the disease, but it couldn’t reduce the relapse rateand improve the long-term outcome of patients. The maintain therapy, that is diseasemodifying therapy(DMT), intends to reduce the recurrence rate, the number of newlesions in the brain and spinal cord of patients, delay the progression of disease courseand finally improve the long-term prognosis of patients. DMT is essential for MS patients.Up to now, Food and Drug Administration(FDA)in USA has approved seven medicationsfor DMT, with varying efficacy and adverse effect profiles, IFN-β is recommended as thepreferred treatment in remission in2010McDonald criteria for MS(A level evidence).Until now, only two medications are approved by SFDA in China: Rebif(IFNβ-1a)andBetaferon(IFNβ-1b), but most MS patients in China couldn’t afford to buy. With theproject of IFNβ-1b in China Charity Federation, which carried out in2012, patients withfinancial difficulty would have chances to use IFNβ-1b. In this way, clinician couldsummary the efficacy of IFN-β1b with more patients. At present, related papers haven’tbeen published in northeast, and different patient may have different clinical efficacy andtolerance to IFN-β1b, different clinician may have different problems in the treatment ofRRMS patiens with IFN-β1b, the clinical efficacy and experience of IFN-β1b in patients with RRMS in northeast deserves further summarized.Objective: To evaluate the clinical efficacy and side-effects of IFN-β1b in patients withRRMS in northeast and analyze the reasons for discontinuation of IFN-β1b, in order toimprove our diagnosis and differential diagnoses and treatment level of RRMS.Methods: We enrolled nineteen patients admitted to the first hospital of Bethune medicalschool, Jilin University at first. With the clinical relapse and the outcomes ofexaminations, three patients were correctly diagnosed as NMOSD, then suggested to stopusing IFN-β1b by doctors.①We compare the annualized relapse rate(ARR), expandeddisability status scale(EDSS)score before and after the treatment of the sixteen RRMSpatients to evaluate the clinical efficacy of IFN-β1b.②We summarize the side-effectsand its severity of IFN-β1b to evaluate the security of IFN-β1b.③We analyze thereasons for discontinuation of IFN-β1b, summarize the clinical characteristics of the threeNMOSD patients to improve our diagnosis, differential diagnoses and treatment level ofRRMS and NMO/NMOSD.Results: The duration of follow-up varies from8to20months in the sixteen patients,15.5months in average.①The average time of using IFN-β1b of the sixteen patients is11.7month, ARR before and after the treatment is(1.65±1.01)and(0.97±1.00), t=2.307,p＜0.05, EDSS score is(2.63±1.04)and(2.03±1.58), t=2.164, p＜0.05, differences arestatistically significant.②Twelve out of sixteen patients ever had side-effects of IFN-β1band there were twenty-one cumulative numbers of side-effects, that is flu-like symptoms(9/21), injection site reactions(7/21), abnormal live function(3/21), slightly reduction ofWBC(1/21)and hair loss(1/21). Three patients needed to take oral NSAIDs to reliveflu-like symptoms, one patient stopped IFN-β1b for two months becasuse of the abnormallive function though added liver-protecting medicines, after the interruption, liverfunction returned to normal with IFN-β1b subcutaneous injection, one patient ceased touse IFN-β1b becasuse of persistent abnormal live function, other patients could alleviateby themselves.③There were five patients ceased to use IFN-β1b in our research, oneceased beacause of the persistent abnormal live function, one thought IFN-β1b is useless beacause the acute attack after using IFN-β1b in one week, three patients werecorrectly diagnosed as NMOSD, then suggested to stop using IFN-β1b by doctors.Conclusions:①The research indicates that IFN-β1b could reduce the ARR and EDSSscore of RRMS patients, delay the progression of clinical course.②Flu-like symptomsand injection site reactions are the most common side-effects of IFN-β1b, abnormal livefunction could also seen in some patients.The majority of side-effects could alleviate bypatients themselves, the rarely severe side-effects could be tolerated by reduction orinterrupting use for a while.③The diagnosis of RRMS in early stage is difficulty,especially with the differential diagnosis of atypical NMO/NMOSD.