PracticeUpdate: Neurology - Winter 2018

ANZAN 2018 19

alemtuzumab-treated patients achieved 6-month confirmed disability improvement (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 exten- sion, 338 (86%) remained in the study through year 6. Fifty percent received nei- ther alemtuzumab retreatment 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 sta- ble 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 cere- bellar (44%) systems. Twenty-one percent to 25% showed improvement in the

records at each site. Deidentified aggre- gated data were analyzed using descriptive statistics and compared with phase III clini- cal 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 follow-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 out- comes in a real world setting were similar to those seen in phase III clinical trials. Autoimmune diseases occurred in a simi- lar proportion to those seen in clinical trials.

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 ver- sus trial data. Patients treated with alemtuzumab for MS since the drug became available in Aus- tralia were reviewed retrospectively. Demographic, clinical, and MRI data were collected systematically from available

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VOL. 3 • NO. 3 • 2018