Chataway, J;
Martin, K;
Barrell, K;
Sharrack, B;
Stolt, P;
Wraith, D;
for the ATX-MS 1467 Study Group;
(2018)
Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis.
Neurology
, 90
(11)
, Article e962. 10.1212/WNL.0000000000005118.
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Abstract
Objective: To assess safety, tolerability and efficacy of the antigen-specific immunotherapy ATX-MS-1467 in participants with relapsing multiple sclerosis (RMS) using different treatment protocols to induce tolerance. Methods: Two open-label trials in adult participants with RMS. Study 1 was a multicentre Phase 1b safety evaluation comparing intradermal (i.d., Cohort 1) with subcutaneous (Cohort 2) administration in 43 participants. Both cohorts received ATX-MS-1467 dosed at 25, 50, 100, 400, and 800 μg at 14-day intervals over 8 weeks, followed by 8 weeks with 4 additional 800 μg doses at 14-day intervals and 32 weeks off study medication. Study 2 was a Phase 2a, multicentre, single-arm, trial enrolling 37 participants. ATX-MS-1467 was titrated from 50 µg i.d. on Day 1 to 200 µg on Day 15 and 800 µg on Day 29 followed by biweekly administration of 800 μg for 16 weeks and 16 weeks off study medication. Efficacy was evaluated on MRI parameters and clinical variables. Safety end points included treatment-emergent adverse events and injection-site reactions. Results: In Study 1 there was a significant decrease in new/persisting T1 GdE lesions in Cohort 1 from baseline to Week 16, returning to baseline values at week 48. In Study 2, the number of T1 GdE lesions were significantly reduced on treatment and remained reduced at study completion. Safety results were unremarkable in both studies. Conclusion: Relatively slow ATX-MS-1467 titration and a longer full-dose i.d. treatment period is associated with reduction in GdE lesions and a sustained effect post-treatment. Further trials of ATX-MS-1467 are warranted. Classification of Evidence: This work provides Class IV evidence that for patients with relapsing multiple sclerosis, slow ATX-MS-1467 titration and a longer full-dose i.d. treatment period is associated with reduction in GdE lesions.
| Type: | Article |
|---|---|
| Title: | Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1212/WNL.0000000000005118 |
| Publisher version: | https://doi.org/10.1212/WNL.0000000000005118 |
| Language: | English |
| Additional information: | This version is the version of record. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | All Clinical trials, Multiple sclerosis, Class III |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10040441 |
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