Poster Ectrims - Rigoni

Alemtuzumab as induction vs escalation therapy:
efficacy and adverse events in the real-world

E. Rigoni 1, V. Singh-Curry,2 A. Nandoskar2, O. Malik2, R. Dorsey2, R. Bergamaschi1, P. Muraro2, R. Nicholas2, A. Scalfari2
1 Pavia University, I.R.C.C.S Mondino Foundation, 2 Imperial College, London, UK
Background and aims: because of safety concerns the use of Alemtuzumab (ATZ) has been recently restricted to 3rd line therapy. We assessed clinical and safety
outcomes, among 124 RRMS patients, who received two courses of ATZ, as first-line (FL) or escalation (ESC) therapy, and were followed up for 38 mean months.
Methods: we retrospectively analysed data gathered at the MS unit of Imperial College Healthcare Trust. We compared the proportion of patients experiencing
disease activity (relapses, ≥ 1 EDSS point worsening, new MRI T2 lesions) between the FL and the ESC groups. Kaplan Meier analysis estimated the time to disease
activity from the 1st ATZ infusion. The logistic regression analysis estimated the risk of experiencing disease activity.
Results:
Table 1: clinical and demographic features of patients grouped by treatment strategy
Twenty-five (21%) patients received ATZ as first-line
First-line (n=25) Escalation (n=99) p-value treatment and 99 (79%) as escalation therapy.
Female, N (%) 17 (68) 58 (58.6) 0.39
Baseline EDSS, mean (SD) 3 (2) 4 (1.8) 0.05 Table 1 shows baseline features of our cohort.
Age at 1st course, mean yrs (SD) 38 (11.2) 43 (9.4) 0.019 Compared to ESC group, patients in the FL group were
significantly younger, less disabled and had a shorter
Disease duration, mean yrs (SD)* 4.2 (3.9) 9.3 (6.2) < 0.001
disease duration.
Follow-up, mean months (SD) 35.5 (17.4) 38.8 (19.9) 0.45
*Data available for 94 patients (25 induction and 69 escalation group)
Figure 1: Proportion of patients, experiencing NEDA-3, EDSS worsening, clinical relapse and Figure 2: Kaplan Meier analysis; estimated time to EDSS progression
radiological activity, in the FL and ESC groups. among patients grouped by treatment strategy
First line group
Escalation group
NEDA-3 EDSS worsening Clinical relapse MRI activity

NEDA-3: no EDSS worsening, no relapses and no new MRI T2 lesions
In the whole cohort, 66 (53%) patients had NEDA-3 (no relapses, disability worsening, or MRI activity), while 58 (47%) experienced disease breakthrough 1.7
mean years from the 1st ATZ infusion; the proportion of patients with NEDA-3 was significantly higher in the FL group (Fig. 1). Patients in the ESC group
experienced in larger proportion disability progression (Fig. 1) and took shorter time to EDSS worsening (Fig. 2). The occurrence of relapses and new MRI
activity was similar in the two groups.
Figure 3: Univariate (A) and multivariate (B) logistic regression analysis; variables affecting the risk of ≥ 1 EDSS point worsening
A univariate analysis B multivariate analysis
OR (CI) OR (CI)
Baseline EDSS 0.9 (0.7-1.1) p= 0.42 0.7 (0.6-1.1) p= 0.11
Escalation group 3.8 (1.1-13.7) p= 0.039 1.7 (0.3-7.7) p= 0.51

Sex(F) 0.9 (0.4-2.1) p= 0.88 0.6 (0.2-1.7) p= 0.33
Disease duration 1.1 (1.0-1.2) p= 0.02 1.0 (0.9-1.1) p= 0.45
Age at first course 1.1 (1.0-1.1) p= 0.006 1.1 (1.0-1.2) p= 0.003
The logistic regression analysis demonstrated higher probability of experiencing disability worsening among patients in the ESC group, those with longer
disease duration and with older age at first ATZ infusion (Fig. 3A). In the multivariate analysis older age at first ATZ infusion was the only variable significantly
associated with higher risk of EDSS progression (Fig . 3B). The proportion of patients experiencing autoimmune adverse events (AE) was similar in the two
groups (Fig. 4).
Conclusions: Figure 4: proportion of patients with immune AE
Early aggressive therapeutic suppression of inflammatory activity associates with better clinical outcome.
Patients receiving ATZ as first line treatment have higher chances of remaining free of disease activity and
lower risk of experiencing EDSS worsening.
Our data also showed that older patients are more likely to experience disease activity while on treatment,
confirming the influence of age on the therapeutic response.
Overall, our results show that the use of ATZ under recent restriction targets a population which is likely to p = 0.58
have a suboptimal therapeutic response.
Disclosures:
E. Rigoni reports no disclosures. V. Singh-Curry reports no disclosures. A. Nandoskar reports no disclosures. O. Malik
reports no disclosures. R. Dorsey reports no disclosures. R. Bergamaschi reports no disclosures. P. Muraro reports no
disclosures. R. Nicholas reports no disclosures. A. Scalfari reports no disclosures.

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Alemtuzumab as induction vs escalation therapy:

efficacy and adverse events in the real-world

First line group

NEDA-3 EDSS worsening Clinical relapse MRI activity

Escalation group 3.8 (1.1-13.7) p= 0.039 1.7 (0.3-7.7) p= 0.51

Conclusions: Figure 4: proportion of patients with immune AE

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