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Authors: Dr Seyed-Masoud Nabavi, Dr Nahid Beladi moghaddam, Dr Roya Abolfazli, Dr Mohsen Shati

Introduction: Beta interferon is widely used in Relapsing-Remitting MS(RRMS). Recently, there has been increasing demand for beta-interferons in Iran since the number of patients with RRMS has been increasing. According to regulations of ministry of health of Iran, a phase-III clinical trial should be performed prior to approval of biosimilar medications in our country.

Methods: patients aged 18-55 years who had RRMS and Expanded Disability Status Scale(EDSS)of 0-5.5 were referred by neurologists and 51 patients who signed the informed consent form were included. Randomization was done through a balanced block randomization table. Each patient was visited in 2, 4, 12 & 24 weeks after the initiation of the assigned medication; flu-like symptoms(defined as having at least 3 of headache, fever, chills & generalized pain symptoms), injection site adverse reactions, relapse rates, EDSS, compliance & adherence of the patients were charted during each visit; lab tests including CBC, liver and thyroid function tests were also performed in 1, 3 and 6-months follow-up visits; the above data was analyzed using SPSS-V17. Of the included patients so far, only data of 28 patients who have been followed for≥ 6 months are included for analysis in this report.

Results: Mean age of the patients was 33.67+1.4 years and 72.7% were females; 17 patients were receiving Actorif & 11 Rebif. Mean disease duration was 2.6+0.7 years in Actorif & 2.2+0.8 in Rebif patients and the difference was not significant (P≥0.05) mean baseline EDSS was 1.7 in Actorif & 2.1 in Rebif patients.
In the sixth-month follow-up, 11.8% of Actorif & 0% of Rebif patients reported flu-like symptoms after the injection. Of injection site reactions, erythema was observed in 94.1% of Actorif & 72.7% of Rebif patients, itching in 29.4% of Actorif & 27.3% of Rebif patients, transient ecchymosis in 17.6% of Actorif & 18.2% of Rebif patients and necrosis in none of the patients. The differences between Actorif & Rebif patients in the above adverse effects was not statistically significant(P≥0.05). Results of the laboratory tests were either similar in Actorif & Rebif patients or the difference was not significant. Six-month relapse-free rate was 88.2%(n=15) in Actorif & 81.8%(n=9) in Rebif patients and the difference was not significant. In Actorif patients, mean+SE EDSS was 1.6+0.39 sixth-month after initiation of medication, it was 1.9+0.37 in Rebif patients; the difference between baseline & sixth-month EDSS was not significant in any of the groups and neither was the decreasing trend of EDSS between two groups. Drop-out rate was 1 out of 18 in Actorif & 3 out of 14 in Rebif patients which was not significantly different in the two groups.

Conclusion: Although the study still continues, according to the obtained results so far, Actorif seems to be similar to Rebif in safety, efficacy & tolerability.


Authors: Dr Akbar Soltanzadeh, Dr Seyed-Masoud Nabavi, Dr Roya Abolfazli, Dr Farzad Fatehi

Introduction: Beta interferon is widely used in Relapsing-Remitting MS(RRMS). Recently, there has been increasing demand for beta-interferons in Iran since the number of patients with RRMS has been increasing. According to regulations of ministry of health of Iran, a phase-III clinical trial should be performed prior to approval of biosimilar medications in our country.

Methods: patients aged 18-55 years who had RRMS and Expanded Disability Status Scale(EDSS)of 0-5.5 were referred by neurologists and 53 patients who signed the informed consent form were included. Randomization was done through a balanced block randomization table. Each patient was visited in 2, 4, 12 & 24 weeks after the initiation of the assigned medication; flu-like symptoms(defined as having at least 3 of headache, fever, chills & generalized pain symptoms), injection site adverse reactions, relapse rates, EDSS, compliance & adherence of the patients were charted during each visit; lab tests including CBC, liver and thyroid function tests were also performed in 1, 3 and 6-months follow-up visits; Of the included patients so far, only data of 40 patients who have been followed for≥ 6 months was analyzed using SPSSV17.

Results: Mean age of the patients was 30.93+1.15 years and 87.8% were females; 22 patients were receiving Actovex & 18 Avonex. Mean disease duration was 4.7+1.1 years in Actovex & 3.9+0.9 in Avonex patients and the difference was not significant (P≥0.05), mean baseline EDSS was 2.7 in Actovex & 2.0 in Avonex patients.
In the sixth-month follow-up, 18.2% of Actovex & 33.3% of Avonex patients reported flu-like symptoms after the injection. Of injection site reactions, erythema was observed in 13.6% of Actovex & 11.1% of Avonex patients, itching in 13.6% of Actovex & 0% of Avonex patients, transient ecchymosis in 27.3% of Actovex & 0% of Avonex patients and necrosis in none of the patients. The differences between Actovex & Avonex in the above adverse effects was not statistically significant (P≥0.05) except for transient ecchymosis (p=0.02), in which it resolved spontaneously in all the patients. Results of the laboratory tests were either similar in Actovex & Avonex patients or the difference was not significant.
Six-month relapse-free rate was 63.6% (n=14) in Actovex & 72.2 % (n=13) in Avonex patients & again, the difference was not statistically significant(P=0.6). In Actovex patients, mean+SE EDSS was 2.5+0.36 six-month after initiation of medication, it was 1.8+0.44 in Avonex patients; the difference between baseline & sixth-month EDSS was not significant in any of the groups and neither was the decreasing trend of EDSS between two groups. Drop-out rate was 1 out of 23 in Actovex & 0 in Avonex patients which were not significantly different in the two groups.

Conclusion: Although the study still continues, according to the obtained results so far, Actovex seems to be similar to Avonex in safety, efficacy & tolerability.

Authors: Dr Koorosh Gharagozli, Dr Seyed-Masoud Nabavi, Dr Roya Abolfazli, Dr Nahid Beladi Moghaddam

Introduction: Beta interferon is widely used in Relapsing-Remitting MS (RRMS). Recently, there has been increasing demand for beta-interferons in Iran since the number of patients with RRMS has been increasing. According to the regulations of ministry of health of Iran, a phase-III clinical trial should be performed prior to approval of biosimilar medications in our country.

Methods: patients aged 18-55 years who had RRMS and Expanded Disability Status Scale (EDSS)of 0-5.5 were referred by neurologists and 59 patients who signed the informed consent form were included. Randomization was done through a balanced block randomization table. Each patient was visited in 2, 4, 12 & 24 weeks after the initiation of the assigned medication; flu-like symptoms(defined as having at least 3 of headache, fever, chills & generalized pain symptoms), injection site adverse reactions, relapse rates, EDSS, compliance & adherence of the patients were charted during each visit; lab tests including CBC, liver and thyroid function tests were also performed in 1, 3 and 6-months follow-up visits; the above data was analyzed using SPSS-V17. Of the included patients so far, only data of 41 patients who have been followed for≥ 6 months are included for analysis in this report.

Results: Mean age of the patients was 31.68+1.27years and 70.7% were females; 22 patients were receiving Actoferon & 19 Betaferon. Mean disease duration was 6.4+1.6 years in Actoferon & 3.6+0.8 in Betaferon patients and the difference was not significant (P≥0.05), mean baseline EDSS was 3.0 in Actoferon & 2.5 in Betaferon patients. In the sixth-month follow-up, 13.6% of Actoferon & 11.8% of Betaferon patients reported flu-like symptoms after the injection. Of injection site reactions, erythema was observed in 63.6% of Actoferon & 58.8% of Betaferon patients, itching in 27.3% of Actoferon & 29.4% of Betaferon patients, transient ecchymosis in 13.6% of Actoferon & 29.4% of Betaferon patients and no necrosis was reported in both groups. The differences between Actoferon & Betaferon patients in the above mentioned adverse effects were not statistically significant (P≥0.05). Results of the laboratory tests were either similar in Actoferon & Betaferon patients or the difference was not significant (P≥0.05). Six-month relapse-free rate was 60%(n=13) in Actoferon & 79%(n=15) in Betaferon patients & again, the difference was not statistically significant(P=0.3). In Actoferon patients, mean+SE EDSS was 2.6+0.36 six-month after initiation of medication, it was 2.3+0.34 in Betaferon patients; the difference between baseline & sixth-month EDSS was significant within each one of groups(p=0.02) but the decreasing trend of EDSS during these six months was not significant between two groups(P≥0.05). Drop-out rate was 0 in both groups.

Conclusion: Although the study still continues, according to the obtained results so far, Actoferon seems to be similar to Betaferon in safety, efficacy & tolerability.

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