Contributions
Abstract: P1864
Type: Poster
Abstract Category: Late breaking news
Background: Neuromyelitis Optica spectrum disorder (NMOSD) often follows a relapsing course. As disability in NMOSD is attack-related, effective treatments are needed. We aimed to compare the efficacy of azathioprine (AZA) and rituximab (RIT) as maintenance therapy in NMOSD patients.
Methods: An open, randomized clinical trial conducted during September 2015 to December 2016, in Isfahan, Iran. Initially 100 NMOSD patients were approached, 86 entered the study and 68 cases completed the trial. All patients had a relapsing-remitting course with expanded disability extended scale (EDSS) ≤7 (median 2.75, range=0-7). Patients were randomized into two groups, which did not differ according to age, gender distribution and disease duration. In the AZA group 35 patients (20 aquaporin-4 (AQP4)-IgG positive) were started on 50 mg/day oral AZA, increased to 2-3 mg/kg/day (with oral prednisolone as adjunctive therapy). In the RIT group 33 patients (13 aquaporin-4-IgG positive), received 1 g intravenous rituximab, repeated two weeks later, and then every six months. Annualized relapse rate (ARR) was measured as the primary outcome, and EDSS as the secondary outcome after 12 months of intervention.
Results: The mean ARR (standard deviation [SD]) in the AZA group decreased from 1 (0.38) to 0.51 (0.55) (P-value< 0.001) and in the RIT group decreased from 1.30 (0.68) to 0.21 (0.42) (P-value< 0.001). ARR after intervention minus ARR before intervention (mean [SD]) was 1.09 (0.72) in RIT group and 0.49 (0.59) in AZA group (P-value< 0.001). EDSS after intervention minus EDSS before intervention (mean [SD]) was 0.98 (1.14) in RIT group and 0.44 (0.54) in AZA group (P-value< 0.001). Nineteen patients (54.3%) in AZA group and 26 patients (78.8%) in RIT group became relapse-free after intervention (P-value=0.033).
Conclusion: AZA and RIT can both effectively decrease ARR and EDSS in NMOSD patients. RIT was significantly more effective than AZA treatment.
Disclosure:
Zahra Nikoo: nothing to disclose
Shervin Badihian: nothing to disclose
Vahid Shaygannejad: nothing to disclose
Nasrin Asgari: nothing to disclose
Fereshteh Ashtari: nothing to disclose
Source of funding: The study was funded by vice-chancellor for research and technology of Isfahan University of Medical Sciences under grant number 395275.
Abstract: P1864
Type: Poster
Abstract Category: Late breaking news
Background: Neuromyelitis Optica spectrum disorder (NMOSD) often follows a relapsing course. As disability in NMOSD is attack-related, effective treatments are needed. We aimed to compare the efficacy of azathioprine (AZA) and rituximab (RIT) as maintenance therapy in NMOSD patients.
Methods: An open, randomized clinical trial conducted during September 2015 to December 2016, in Isfahan, Iran. Initially 100 NMOSD patients were approached, 86 entered the study and 68 cases completed the trial. All patients had a relapsing-remitting course with expanded disability extended scale (EDSS) ≤7 (median 2.75, range=0-7). Patients were randomized into two groups, which did not differ according to age, gender distribution and disease duration. In the AZA group 35 patients (20 aquaporin-4 (AQP4)-IgG positive) were started on 50 mg/day oral AZA, increased to 2-3 mg/kg/day (with oral prednisolone as adjunctive therapy). In the RIT group 33 patients (13 aquaporin-4-IgG positive), received 1 g intravenous rituximab, repeated two weeks later, and then every six months. Annualized relapse rate (ARR) was measured as the primary outcome, and EDSS as the secondary outcome after 12 months of intervention.
Results: The mean ARR (standard deviation [SD]) in the AZA group decreased from 1 (0.38) to 0.51 (0.55) (P-value< 0.001) and in the RIT group decreased from 1.30 (0.68) to 0.21 (0.42) (P-value< 0.001). ARR after intervention minus ARR before intervention (mean [SD]) was 1.09 (0.72) in RIT group and 0.49 (0.59) in AZA group (P-value< 0.001). EDSS after intervention minus EDSS before intervention (mean [SD]) was 0.98 (1.14) in RIT group and 0.44 (0.54) in AZA group (P-value< 0.001). Nineteen patients (54.3%) in AZA group and 26 patients (78.8%) in RIT group became relapse-free after intervention (P-value=0.033).
Conclusion: AZA and RIT can both effectively decrease ARR and EDSS in NMOSD patients. RIT was significantly more effective than AZA treatment.
Disclosure:
Zahra Nikoo: nothing to disclose
Shervin Badihian: nothing to disclose
Vahid Shaygannejad: nothing to disclose
Nasrin Asgari: nothing to disclose
Fereshteh Ashtari: nothing to disclose
Source of funding: The study was funded by vice-chancellor for research and technology of Isfahan University of Medical Sciences under grant number 395275.