ACTRIMS-ECTRIMS 2020 HIGHLIGHTS – SATURDAY, SEPTEMBER 12 EDITION

 

8th Joint Americas Committee and European Committee for Treatment and Research in MS (ACTRIMS-ECTRIMS) meeting, Virtual Congress, 11-13 September 2020.

The following summarizes some of the highlights from Day 2 of ACTRIMS-ECTRIMS 2020.

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CONGRESS HIGHLIGHTS – SATURDAY EDITION

Vaccination
Cladribine – onset of treatment effect
Sequencing has effects on Ig
Long-term data
Cannabis
Clinical tip of the day

Vaccination
Hepatitis B vaccination: Two studies reported that high-efficacy DMTs may reduce the response to Hep B vaccines. A single-centre study looked at seroconversion rates in 101 patients (mean age 45.7 years) who were untreated or receiving a first-line injectable (BRACE), a first-line oral, fingolimod or natalizumab (Faustino et al. ECTRIMS 2020; abstract P0390). An accelerated HBV vaccination schedule was used consisting of three doses on Days 0, 7 and 21, with a fourth dose if required. The overall seroconversion rate was 69.3%; the rate was 74.1% in patients aged < 50 years and 69.2% in patients >50 years, suggesting that the effects of immunosenescence were minimal. However, the seroconversion rate was significantly lower for patients on non-BRACE DMTs compared to those on BRACE or no treatment (54.1% vs. 85.2% vs. 81.8%).

A separate study looked at the hepatitis B seroconversion rate among 153 MS patients (mean age 48 years) on treatment (Otero-Romero et al. ECTRIMS 2020; abstract P0290). Vaccinations were administered at months 0, 1, 2 and 6-12, with serology obtained 1 month after the last dose. The overall seroprotection rate was 66.7%; the highest rates were in untreated patients (94.1%) and those receiving injectables, dimethyl fumarate, teriflunomide or natalizumab (96.8%). If DMT-treated patients were switched to an anti-CD20 therapy during the series of vaccinations, the seroprotection rate declined substantially to 18.2%-52.2%. The seroprotection rate was higher for patients completing more of the scheduled vaccine doses before receiving anti-CD20 therapy: 16.7%, 30%, 66.7% and 92.9% with one, two, three and four vaccine doses, respectively.

Yellow fever vaccination: A new study found that the yellow fever vaccine is not associated with an increased risk of relapses or disability worsening when administered to MS patients (Papeix et al. ECTRIMS 2020; abstract P0480). The retrospective study compared 32 vaccinated MS patients with 96 non-vaccinated MS controls; groups were matched for age, sex and annualized relapse rate (ARR) in the year prior to vaccination. ARR in the year after vaccination was 0.233 with vaccination compared to 0.213 for MS controls. The times to relapse and disability progression were comparable with and without vaccination. It should be noted that the yellow fever vaccine is a live attenuated vaccine that should not be administered during treatment with a DMT. The vaccine is required for travel to endemic regions (www.who.int/publications/m/item/countries-with-risk-of-yellow-fever-transmission-and-countries-requiring-yellow-fever-vaccination-(july-2019).

Cladribine – onset of treatment effect
The MAGNIFY-MS study (n=270) examined the onset of treatment effect in the first six months of oral cladribine; treatment was administered in weeks 1 and 5 in years 1 and 2 (cumulative dose 3.5 mg/kg) (De Stefano et al. ECTRIMS 2020; abstract P0382). MRIs were obtained at screening, baseline, and at months 1, 2, 3 and 6. A reduction in the number of combined unique active (CUA) lesions was seen at month 1. The reduction from baseline in CUA was 61% at month 1, 77% at month 2 and 89% at month 3. The proportion of patients with no CUA lesions was 52% at month 1, 66% at month 2 and 81% at month 3. The results indicate that there is a therapeutic effect before the complete two-year course of cladribine is completed.

Sequencing has effects on Ig
Concerns have been raised about the possible effects on immune competence of sequential disease-modifying therapies. A study compared whole-blood samples from 133 RRMS patients (aged 17-66 years) versus patients with other neurological conditions and healthy controls (Keiner et al. ECTRIMS 2020; abstract P0058). There were similar age-related declines in immune subsets among the three groups indicating immunosenescence. What was noteworthy, however, was an age-related decline in CD19+ IgG+ B cells that was specific to the MS group; mean values were lower in treated versus untreated MS patients. Interestingly, the treated group had not received B cell-depleting therapy. The authors stated that their findings suggest a cumulative effect of DMTs on selected immune subsets.

Long-term data
Dimethyl fumarate: A majority of patients on continuous DMF 240 mg BID for up to 13 years remained relapse-free with minimal disability, according to the results of the ENDORSE extension study (Gold et al. ECTRIMS 2020; abstract FC02.05). ARR was 0.14. A total of 60% of patients were relapse-free with continuous DMF; an additional 20% experienced one relapse. Moreover, 72% experienced no 24-week confirmed disability progression over 10 years. The proportion of patients with an EDSS score < 3.5 was 86% in year 2 and 77% in year 10. The absolute lymphocyte count declined during the first year and was stable thereafter; a low lymphocyte count was not associated with an increased risk of opportunistic infections. The rate of discontinuations due to gastrointestinal adverse effects was 4%.

Natalizumab: The Swedish Immunomodulation and Multiple Sclerosis Epidemiology Study (IMSE-1) study analysed data for 171 patients treated with natalizumab for at least 10 years (mean 139 months) (Kagstrom et al. ECTRIMS 2020; abstract P0331). Mean ARR was 0.84 in the year prior to natalizumab initiation and 0 in the first year of treatment. Over the 10-year treatment period, there were significant reductions in mean MS Severity Scale (MSSS) score, MS Impact Scale (MSIS-29) score and SDMT score, and a non-significant improvement in EDSS score. A total of 21% discontinued treatment; 9.5% discontinued due to JCV Ab positivity. For the entire cohort of patients with natalizumab during the observation period (n=3291), there were 9 cases of PML (2 deaths; PML prevalence 0.27%).

Cannabis
A NARCOMS survey examined cannabis use (excluding CBD products) among U.S. patients in the database (n=3249) (Salter et al. ECTRIMS 2020; abstract P0439). Respondents were predominantly female (78.5%), Caucasian (88.5%) and older (mean age 61.2 years). Median self-rated disability was a score of 3 (gait disability) on the Patient-Determined Disease Steps (PDDS) scale. Overall, 31% of respondents said they had used cannabis for their MS symptoms, such as spasticity (50.5%), pain (43.6%) and sleep (38.4%). A total of 19.6% reported they had used cannabis in the preceding month.

Clinical tip of the day
Hypertension is often undertreated in MS patients. In the MS PATHS study (n=2718), 27.9% of MS patients had at least two BP measurements indicating hypertension (SBP >130 mmHg and/or DBP >90 mmHg) (Bassi & Conway. ECTRIMS 2020; abstract P0466). Among those with at least two elevated BP readings, only 36.7% were being treated with an antihypertensive medication.

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