Clinical Benefits with Aimspro® in Progessive Multiple Sclerosis: Open Label Study

Background: We report here self and physician reported clinical efficacy of AIMSPRO® in 140 patients with a clinically definite diagnosis of multiple sclerosis. Patients were treated with 4.5mg/ml AIMSPRO® 1-2x weekly on an open-label basis.

Objectives:

To review possible clinical effests of AIMSPRO in patients with progressive MS.

Methods:

Multi-centre retrospective analysis of the clinical outcomes was made using patient’s clinical notes and/or the patient’s own clinical diaries by a single neuro-clinician with experience in EDSS scoring (CEGM). Detailed reports of the effects of the medication contained within patient diaries, clinical notes and questionnaires were used. All clinical improvements, observed or reported were scored in alignment with the expanded disability status score (EDSS) ‘equivalent’, an estimate of the change in the numerical scale that might be expected had formal clinical grading been undertaken prospectively. A +2 improvement would likely reduce a patient’s symptom score by an EDSS of 0.5. More than one +1 improvement would be needed for a similar overall change. Changes in 8 areas sensory/pain, motor, bladder, ataxia, sleep, vision, energy, and ‘other’ were scored: marked improvement; (+2); some improvement, (+1); no change, 0; some worsening, -1; marked worsening, -2.

Results:

154 progressive MS patients were treated. 140 patients had documented follow-up/ assessment available for review. The mean age was 47 yrs. The duration of the disease ranged from 3 months to 40 yrs (mean =13.6 yrs). The vast majority were in the secondary progressive phase of the illness.The dosage range was 4.5mg 2-3x per week to 4.5mg 1-2x per week. The duration of treatment ranged from 2 weeks to 3 yrs (from 3 to 150 doses of AIMSPRO® 4.5mg).

100 patients had improvement in > 2 areas and as such were likely to have a change of at least -0.5 in their EDSS score. 122 patients showed clinical benefit in > 1 areas (n=22 patients showed one area, 40-two, 27-three, 24-four, 7-five and 2-six areas of improvement), 16 patients reported no overall benefit, 2 patients showed overall worsening by 1 point in 1 area.

Conclusions:

These clinical observations suggest that AIMSPRO® therapy stopped the decline in progressive MS and may have a restorative effect in multiple clinical areas.

A phase II double-blinded placebo controlled trial reported in Q1 2013. Primary endpoints of bladder function showed no change after 4 weeks treatment. Some secondary endpoints including MSFC showed clinical benefit which were extended during 6-12 months, post blinded, open label treatment.