PracticeUpdate Conference Series - ANZAN 2018

vs subcutaneous interferon ß-1a over 2 years in patients with RRMS with inade- quate response to prior therapy. A significantly greater percentage of alemtuzumab-treated patients achieved 6-month confirmed disability improve- ment (CDI). Efficacy remained durable in a 4-year extension. Dr. Macdonell and colleagues set out to assess alemtuzumab efficacy on disability at the level of functional system scores of the EDSS over 6 years. EDSS and individual functional system scores were recorded at baseline and quarterly; CDI (≥1.0-point EDSS decrease confirmed over 6 months) was assessed in patients with baseline EDSS score ≥2.0. Of the 393 patients who entered the extension, 338 (86%) remained in the study through year 6. Fifty percent received neither alemtuzumab retreat- ment nor other disease-modifying therapy after the initial two courses. Through years 3–6, 76–80% of patients showed stable (≤0.5-point change) or improved (≥1.0-point decrease) EDSS scores vs the core study mean baseline score of 2.7 (1.2). At least 75% were stable or improved in each functional system. Through year 6, 43% achieved 6-month CDI and 96% of patients with CDI scored <4 on the EDSS. Of patients with CDI, 71% achieved improvements in more than one functional system. Improvements were observed in each functional system, most frequently in

the sensory (48%), pyramidal (44%), and cerebellar (44%) systems. Twenty-one percent to 25% showed improvement in the brainstem, cerebral, visual, and bowel/ bladder functional systems. Dr. Macdonell concluded that most (86%) patients in CARE-MS II patients who entered the extension remained in the study through year 6. At least 75% of alemtuzumab-treated patients exhibited improved or stable scores across all func- tional systems over 6 years. Improvements were seen for each func- tional system in patients with 6-month CDI. Of these patients, 71% showed improve- ments in more than one functional system, which indicated a broad treatment effect with alemtuzumab in multiple aspects of disability improvement. Simon A. Broadley, PhD, MBChB, BSc, of Griffith University in Queensland, and colleagues set out to assess real- world experience of treating MS with alemtuzumab. Dr. Broadley explained that alemtuzumab is highly effective for MS and possesses a significant but well-defined adverse event profile. Dr. Broadley and colleagues reported cases treated since the commercial release of alemtuzumab at two centers. Their aim was to compare real-world experience vs trial data. Patients treated with alemtuzumab for MS since the drug became available in Australia were reviewed retrospectively.

Demographic, clinical, and MRI data were collected systematically from avail- able records at each site. Deidentified aggregated data were analyzed using descriptive statistics and compared with phase III clinical trial data. A total of 104 cases treated with alemtu- zumab were identified. Median patient age at first treatment was 38 (17–55) years, slightly older than the trial populations (33 and 35 years). Two-thirds of patients were female. Mean disease duration was 8.4 ± 7.0 years, longer than in the trials (2.1 and 4.5 years). Patients experienced a median of 3 (1 to 12) prior relapses, 1 (0 to 3) in the prior 2 years. They had received a median of 1.5 prior treatments for MS. The median follow-up duration was 20 (1–35) months. Median EDSS score at the time of first treatment was 2 (0–7), and at last fol- low-up, 1.5 (0–7). At last follow-up, 24/104 (23%) patients had improved. Of 104 patients, 61 (58%) were stable and 9 (9%) had worsened. Autoimmune adverse events were seen in 18/104 (17%), the most common (13/104, 13%) being autoimmune thyroid disease. Dr. Broadley concluded that alemtuzumab is an effective therapy for MS. Clinical outcomes in a real world setting were similar to those seen in phase III clinical trials. Autoimmune diseases occurred in a similar proportion to those seen in clinical trials.

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ANZAN 2018 • PRACTICEUPDATE CONFERENCE SERIES 15