Contributions
Abstract: P681
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Introduction: Clinical trials have established efficacy of alemtuzumab in relapsing-remitting MS (RRMS), but data from non-controlled settings is limited. Here, we report data on alemtuzumab-treated RRMS patients in a British Columbia cohort, and compare their outcome to concurrent RRMS patients that were denied alemtuzumab by their drug insurance coverage and treated with other MS disease modifying therapies (DMTs).
Methods: In a single center (UBC MS Clinic), a retrospective chart review was conducted. Prior to government reimbursement of alemtuzumab, only patients with extended insurance coverage who met clinical criteria were eligible for therapy. The alemtuzumab cohort included those who had at least one cycle of therapy from July 2014-July 2016. Patients with lack of reimbursement were used as a contemporary control cohort. Clinical outcomes included annualized relapse rate (ARR) and change in EDSS. Improvement was defined as a 1-point decrease sustained over 6 months, stability between -1 and 1, and worsening as a 1-point increase.
Results: 73 RRMS patients received alemtuzumab (41 received 2 cycles, 32 had 1 cycle). The comparison group included 51 patients similar in pre treatment ARR, EDSS and demographics. At the time of first data extraction mean follow-up was 13.2 months (ranging from 1 to 24 months). The post treatment ARR was 0.13 (95% CI: 0.04-0.22) for alemtuzumab versus 0.36 (0.17-0.56) for the comparator group, which was significantly different using a two-sample t-test (p=0.0241). Within-group comparisons to pretreatment values showed that mean EDSS improved in the alemtuzumab group by 0.5 at 12 months (SD 1.20; 95% CI: -0.94 to -0.09; p=0.02) by Wilcoxon matched-pairs signed rank test. There was no significant change in EDSS in the control group (mean EDSS decrease of 0.3 (SD 1.12; 95% CI: -0.78 to 0.13; p=0.2). At last follow-up, 39% of alemtuzumab-treated patients improved from pretreatment values on the EDSS Scale, 39% were stable, and 22% worsened. In the comparator group, 26% had improvement, 50% were stable, and 24% worsened. The year 2 (July 2017) follow-up data is being analyzed and will be presented at the meeting.
CONCLUSION: The effectiveness of alemtuzumab in RRMS in a real world setting is similar to what is reported in phase 3 clinical trials. Alemtuzumab-treated patients had better relapse and disability outcomes than a similar group of RRMS patients denied alemtuzumab that then went on to other MS DMTs.
Disclosure:
Heather Yong, Virginia Devonshire, and Ana-Luiza Sayao declare no conflict of interests.
Philippe Beauchemin: Consulting fees: Novartis, EMD Serono, Biogen and Roche Canada; no relevant disclosures.
Krista Barclay: compensation for consultation and a travel grant from Sanofi Genzyme Canada.
Robert Carruthers: Grants/Research Support: Site PI for studies funded by MedImmune, Teva and Guthy Jackson.Speakers Bureau/Honoraria: Speaking fees for unbranded lectures from Biogen, Genzyme and Teva. Consulting Fees: Novartis, EMD Serono, Genzyme.
Anthony Traboulsee: received grant funding from the MS Society of Canada, Canadian Institute for Health Research, Roche, and Genzyme; received honoraria or travel grants from Teva Canada Innovation, Roche, Merck/EMD Serono, Genzyme, Chugai Pharmaceuticals.
Abstract: P681
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Introduction: Clinical trials have established efficacy of alemtuzumab in relapsing-remitting MS (RRMS), but data from non-controlled settings is limited. Here, we report data on alemtuzumab-treated RRMS patients in a British Columbia cohort, and compare their outcome to concurrent RRMS patients that were denied alemtuzumab by their drug insurance coverage and treated with other MS disease modifying therapies (DMTs).
Methods: In a single center (UBC MS Clinic), a retrospective chart review was conducted. Prior to government reimbursement of alemtuzumab, only patients with extended insurance coverage who met clinical criteria were eligible for therapy. The alemtuzumab cohort included those who had at least one cycle of therapy from July 2014-July 2016. Patients with lack of reimbursement were used as a contemporary control cohort. Clinical outcomes included annualized relapse rate (ARR) and change in EDSS. Improvement was defined as a 1-point decrease sustained over 6 months, stability between -1 and 1, and worsening as a 1-point increase.
Results: 73 RRMS patients received alemtuzumab (41 received 2 cycles, 32 had 1 cycle). The comparison group included 51 patients similar in pre treatment ARR, EDSS and demographics. At the time of first data extraction mean follow-up was 13.2 months (ranging from 1 to 24 months). The post treatment ARR was 0.13 (95% CI: 0.04-0.22) for alemtuzumab versus 0.36 (0.17-0.56) for the comparator group, which was significantly different using a two-sample t-test (p=0.0241). Within-group comparisons to pretreatment values showed that mean EDSS improved in the alemtuzumab group by 0.5 at 12 months (SD 1.20; 95% CI: -0.94 to -0.09; p=0.02) by Wilcoxon matched-pairs signed rank test. There was no significant change in EDSS in the control group (mean EDSS decrease of 0.3 (SD 1.12; 95% CI: -0.78 to 0.13; p=0.2). At last follow-up, 39% of alemtuzumab-treated patients improved from pretreatment values on the EDSS Scale, 39% were stable, and 22% worsened. In the comparator group, 26% had improvement, 50% were stable, and 24% worsened. The year 2 (July 2017) follow-up data is being analyzed and will be presented at the meeting.
CONCLUSION: The effectiveness of alemtuzumab in RRMS in a real world setting is similar to what is reported in phase 3 clinical trials. Alemtuzumab-treated patients had better relapse and disability outcomes than a similar group of RRMS patients denied alemtuzumab that then went on to other MS DMTs.
Disclosure:
Heather Yong, Virginia Devonshire, and Ana-Luiza Sayao declare no conflict of interests.
Philippe Beauchemin: Consulting fees: Novartis, EMD Serono, Biogen and Roche Canada; no relevant disclosures.
Krista Barclay: compensation for consultation and a travel grant from Sanofi Genzyme Canada.
Robert Carruthers: Grants/Research Support: Site PI for studies funded by MedImmune, Teva and Guthy Jackson.Speakers Bureau/Honoraria: Speaking fees for unbranded lectures from Biogen, Genzyme and Teva. Consulting Fees: Novartis, EMD Serono, Genzyme.
Anthony Traboulsee: received grant funding from the MS Society of Canada, Canadian Institute for Health Research, Roche, and Genzyme; received honoraria or travel grants from Teva Canada Innovation, Roche, Merck/EMD Serono, Genzyme, Chugai Pharmaceuticals.