From the Ectrims site:

http://www.akm.ch/ectrims2006/

Interferon beta-1b 16-year long-term follow-up study: patient-reported outcomes

D. Langdon, G. Ebers, A. Traboulsee, A. Reder, D.S. Goodin, A. Konieczny, C. Miltenburger for the Betaseron/Betaferon LTF Study Group

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Background: Patient-reported outcomes (PRO) and assessment of cognitive function are increasingly recognised as significant contributions to the understanding of the impact that multiple sclerosis (MS) has on patients’ lives, yet very limited data exist. Insights from PRO can improve quality of life (QoL), patient management and treatment response.

The 16-Year Long-Term Follow-up (16-Year LTF) of the original cohort from the interferon beta-1b (IFNB-1b; Betaferon®) pivotal trial, aims to evaluate the long-term effects of IFNB-1b treatment on patient-reported outcomes and cognition, and relate these to clinical and imaging parameters.

Design/Methods: The 16-Year LTF is a multicentre, open-label, observational study that uses cross-sectional data collection from patients having participated in the original pivotal trial.

A comprehensive battery of tests was selected to assess the health-related (HR) QoL and cognitive status of the patients. These included MS-specific PRO questionnaires, such as the Functional Assessment in MS (FAMS) and EuroQoL (EQ-5D).

The results have been analysed according to the length of exposure to treatment over the 16 years, i.e. “always” = IFNB-1b >80% of the time; “ever” = IFNB-1b >10–80% of the time; “never” = IFNB-1b <=10% of the time.

Results: 328 of the original 372 patients (88.2%) have been identified and they are almost equally distributed across the original treatment groups. Analysis of the FAMS total score and trial outcome index (TOI) indicated that patients from the “always” group had an improved score compared with those from the “ever” and “never” groups.

This trend was also seen in the EQ-5D (rating scale and visual analogue scale) total scores. Assessment of EQ-5D subscales demonstrated that more patients from the “always” group reported “No problem in walking about”, “No problem with self-care” and “No problem performing usual activities”. Further PRO and cognition data (currently being analysed) will be presented.

Conclusions: 88.2% of the original patients have been located even after 16 years. Preliminary results indicate that self-reported QoL is better for the “always” patient group compared to the “ever” and “never” groups, and this finding is consistent across different assessments. Furthermore, the FAMS score shows clinically meaningful differences between the groups. These results suggest that early and long-term treatment sustains HRQoL and self-reported functional dependence in patients with MS.

Interferon beta-1b 16-year long-term follow-up study: MRI outcomes


D. Li, G. Ebers, A. Traboulsee, R. Tam, D.S. Goodin, A. Konieczny for the Betaseron/Betaferon LTF Study Group and the UBC MS/MRI Research Group

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Background: The interferon beta-1b (IFNB-1b; Betaferon®) pivotal study demonstrated efficacy, safety and tolerability of IFNB-1b in patients with relapsing-remitting (RR) multiple sclerosis (MS), including a persistent beneficial effect on MRI lesion burden over 5 years.

The 16-year Long-term Follow-up (16-Year LTF) study is hypothesis generating, with the aim to assess the long-term treatment effects of IFNB-1b on clinical outcomes and relate these to changes in MRI outcomes.

Design/Methods: The 16-Year LTF is a multicentre, open-label, observational study utilising cross-sectional data collected from patients from all 11 centres who participated in the original pivotal trial. MRI scans were analysed at a single centre and MRI outcome measures assessed included T2 burden of disease (BOD), normalised brain volume (NBV), gadolinium-enhancing lesions, black holes and cervical cord area at C2 (CCA).

The results have been analysed by stratification according to the original treatment assignment of the pivotal trial (placebo, 50 mcg IFNB-1b subcutaneously [sc] every other day [eod], 250 mcg IFNB-1b sc eod) and also according to the length of exposure to treatment over the 16 years, i.e. “always” = IFNB-1b >80% of the time; “ever” = IFNB-1b >10–80% of the time; “never” = IFNB-1b <=10% of the time.

Results: 328 of the original 372 patients have been identified (i.e. 88.2%). 192 patients underwent MRI studies. Technically adequate C2 CCA data was available in 81 patients. A trend was observed between T2 BOD and increasing disability within the stratified groups. Furthermore, patients with a higher EDSS score tended to have a smaller NBV and reduced CCA. When SPMS status was used as a covariate with T2 BOD, a trend was observed, with less T2 BOD in the “always” group than the “never” group. Further analyses are currently being performed, and results will be presented at the meeting.

Conclusions: Although significant differences between the groups were not observed, preliminary results indicate that the changes in the different MRI measures over time in the whole cohort are in line with expected clinical progression. Moreover, covariates such as SPMS appear to be important when analysing these findings. Measurements of the cervical cord area at C2 provided results consistent with the brain measurements.

Final results from the interferon beta-1b 16-year long-term follow-up study

G. Ebers, A. Traboulsee, D. Li, D. Langdon, D.S. Goodin, A. Reder, A. Konieczny for the Betaseron/Betaferon LTF Study Group

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Background: The pivotal interferon beta-1b (IFNB-1b; Betaferon®) study demonstrated efficacy, safety and tolerability of IFNB-1b in patients with relapsing forms of multiple sclerosis (MS) and led to the first approved immunomodulatory therapy for MS.

The 16-Year Long-Term Follow-up (LTF) study is primarily hypothesis generating, and aims to evaluate the long-term treatment effects of IFNB-1b on clinical and imaging parameters, cognitive function and patient-reported outcomes.

Design/Methods: The LTF is a multicentre, open-label, observational study that evaluates outcomes in patients having participated in the original IFN-1b pivotal trial which began in 1988. Survival, disease status, relapse rate, Expanded Disability Status Scale (EDSS) score, adverse events, magnetic resonance imaging parameters and other data have been collected.

Results to date have been divided and analysed by the original treatment assignment in the pivotal trial (placebo, 50 mcg IFNB-1b subcutaneously [sc] or 250 mcg IFNB-1b sc every other day, and arbitrarily in advance by the duration of treatment.

Over the 16 years results were divided into “never” = IFNB-1b <=10% of the time; “ever” = IFNB-1b >10–80% of the time; “always” = IFNB-1b >80% of the time.

Results: Of the original 372 patients, 328 have been identified (i.e. 88.2%); 293 of these patients are alive and 35 are deceased. Median time from diagnosis was 19 years. Data from 260 patients indicate that 78/260 (30%) patients are currently taking IFNB-1b, and the median length of exposure to IFNB-1b has been almost 10 years (3345 days). Wheelchair use is required by 44.2% of “never” patients and 29.4% of “always” patients. Median time to EDSS 6 was 6 years later for “always” patients than for “never” patients. Annualised relapse rates were lower in the “always” group, compared with the “never” group. Adverse events were uncommon. More detailed analyses are ongoing.

Conclusions: This is the longest and most complete follow-up of any disease modifying drug for MS. After 16 years, 88.2% of patients from the pivotal IFNB-1b trial have been located. Long-term safety of IFNB-1b is excellent. Results are consistent with the hypothesis that continuous long-term treatment positively impacts on the disease course but selection bias cannot be excluded. Comparisons are being made to natural history data from the Ontario cohort. The lack of randomisation and blinding in observational studies may be offset by the clarity of their outcomes.

Hi wannabe,

I think it's great that you're posting these, but I wanted to mention that a lot of our people have vision issues that make it difficult for them to read large connected blocks of text. A number of people have requested that big blocks of text be broken up into smaller chunks with white space in-between.

Thanks.

Mark

I only read the conclusions to these long drawn out, greek speak, anyway..

Sorry about that.

I'll go thru and try to break them up for easier reading.

Thanks for the suggestion!

Could I add to this suggestion?

It's been suggested many times before, and some people take it to mean that

they should break up their text like this, without regard for the ends of sentences. They just type away and when the mood

strikes them, they make a break.

To me, this is almost worse than no breaks.

It seems to me that the breaks should be natural breaks, coming at the end of a sentence and following the meaning of the text by breaking it into logical paragraphs if possible.