Quality Assessment in Multiple Sclerosis Therapy (QUASIMS)

Abstract

Interferon beta (IFN beta) preparations are the most frequently prescribed therapies for patients with relapsing multiple sclerosis (MS). Several open-label observational studies report similar efficacy among IFN beta preparations. The Quality Assessment in Multiple Sclerosis Therapy (QUASIMS) study is a large, open-label observational study designed to compare the effectiveness and tolerability of available IFN beta preparations as disease-modifying therapies for relapsing MS across a wide range of clinical practice settings. This retrospective, controlled cohort study was conducted by chart review at 510 sites in Germany, Austria, and Switzerland. Enrolled patients had received one of the four available IFN beta preparations/dosing regimens (intramuscular IFN beta-1a 30 microg 1x/week [Avonex], subcutaneous (SC) IFN beta-1a 22 or 44 microg 3 x/week [Rebif], or SC IFN beta-1b 250 microg 3.5x/week [Betaferon/Betaseron]) for >or= 2 years. Pre-planned outcomes at 1 and 2 years included change from baseline Expanded Disability Status Scale (EDSS) score, percentage of progression-free patients (< 1.0 EDSS point), annualised relapse rate (RR), percentage of relapse-free patients, and reasons for therapy change. Of 4754 evaluable patients, 3991 (84%) received IFN beta as initial therapy. There were no significant differences among IFN betas when used as initial or follow-up therapy on almost all outcome variables. Relapse rate was consistently higher and percentage of relapse-free patients consistently lower for all products used as follow-up versus initial therapy. Results of QUASIMS showed similar effectiveness among IFN beta products. Benefits were consistently superior when IFN beta was used as initial rather than follow-up therapy. Our results suggest that patients do not benefit in terms of disease outcome from switching between IFN beta preparations/dosing regimens.

Swiss Analysis of Multiple Sclerosis: A Multicenter, Non-Interventional, Retrospective Cohort Study of Disease-Modifying Therapies

“…These results are in line with other short- and long-term real-world postmarketing studies [11,12,13,14,15,16,17,18,19,20,21]. Nevertheless, 2 previous head-to-head trials, EVIDENCE [9] and INCOMIN [10], showed superior efficacy for SC IFNβ compared with IM IFNβ in terms of time to the first clinical MS relapse on study.…”

“…Several open-label, postmarketing, observational studies have reported similar efficacy for the three different IFNβ preparations [11,12,13,14,15,16,17,18,19], but only a few have compared these DMTs and GA [20,21]. There is only one report in the literature comparing the effects of all four different immunomodulatory therapies on MS disease progression in patients with relapsing-remitting MS (RRMS); however, the study groups were quite imbalanced, and the reported differences in hazard ratios between the DMTs were attributed to selection bias [22].…”

Can a physician predict the clinical response to first-line immunomodulatory treatment in relapsing&ndash;remitting multiple sclerosis?

“…Our results, derived from a single center with a small cohort size, are consistent with larger, well-controlled phase III clinical trials and observational studies that have shown equal efficacy among beta IFN products17 and GA,25 probably not only in the short term but in long-term treatment as well, particularly with higher benefit in patients with mild disability and shorter course of disorder at the time of IMT initiation. Relapse-rate reduction in the initial 2 years of treatment predicted clinical efficacy in subsequent years.…”

“…Head-to-head, open-label studies have compared the efficacy and tolerability of IFN beta products and GA for the treatment of relapsing MS. Results of these studies are conflicting, with most suggesting equivalent clinical effects of IFN beta products17,21–25 but some have shown small treatment differences among the agents, such as potential benefit of GA over IFNs26 or SC IFN beta-1a over IM IFN beta-1a in the Evidence of Interferon Dose Response: European North American Comparative Efficacy study18 or potential benefit of SC IFN beta-1b over IM IFN beta-1a in the Independent Comparison of Interferons trial 27. Although the patients in our study were quasi-randomized to different DMAs (patient allocation was decided by medication availability and not by the physician’s decision), they differed in some of the baseline demographics and disease characteristics.…”

Does interferon beta therapy affect survival of multiple sclerosis patients?

“…The problem of mortality has not been raised in open trials such as QUASIMS (Quality Assessment in Multiple Sclerosis Therapy) [32], assessing the efficacy and safety of various interferon beta preparations. Their survey was discussed in detail by Limmoroth et al [33].…”