Comparison of injection site pain and injection site reactions in relapsing-remitting multiple sclerosis patients treated with interferon beta-1a or 1b

This prospective, multicentre, international, observational, cohort study compared injection site pain (ISP) and injection site reactions (ISRS) between interferon beta-1b (IFNB-1b; Betaferon) 250 microg subcutaneously every other day and interferon beta-1a (IFNB-1a; Rebif) 44 microg subcutaneously three times weekly in patients with relapsing-remitting MS. Patients started treatment within 3 months before recruitment and were on full dose of therapy at inclusion. Patients self-injected IFNB and self-assessed ISP for 15 consecutive injections immediately, 30 and 60 min after injection, using a visual analogue scale diary. Study staff assessed ISRS. Of 445 patients (valid cases), approximately 90% used autoinjectors. More patients were pain-free at all timepoints with IFNB-1b than with IFNB-1a (eg, 30 min: 42.6% versus 19.7%; P<0.0001). The mean proportion of pain-free injections was greater for IFNB-1b (eg, 30 min: 79.0%) than for IFNB-1a (53.3%; P<0.0001). The proportion of patients without ISRS was greater for IFNB-1b (second visit 51.8% versus 33.8%; P<0.0001). Compared with IFNB-1a, more IFNB-1b patients either had no pain or their ISP had no influence on treatment satisfaction (76.9% versus 64.1%; P=0.006). The impact on tolerability and patient acceptability of any new IFNB product formulations would, however, have to be evaluated in comparative studies.     

Interferon beta-1b modulates serum sVCAM-1 levels in primary progressive multiple sclerosis

Endothelial activation is a key feature of multiple sclerosis (MS) pathogenesis. It is modulated by interferon beta-1b (IFNB-1b) treatment in relapsing-remitting MS (RRMS) patients. This particular pharmacodynamic effect still has to be proven in primary progressive MS (PPMS). In the current study, serum concentrations of soluble vascular cell adhesion molecule-1 (sVCAM-1) and sE-selectin were analyzed longitudinally in 18 PPMS patients before, during and after 12 months of treatment with IFNB-1b. During drug therapy there was a significant early and sustained increase of sVCAM-1 (overall P < 0.0001). Flu-like symptoms induced by IFNB-1b and also concomitant infections were associated with higher sVCAM-1 levels. Neutralizing antibodies to IFNB-1b were associated with lower sVCAM-1 levels. In conclusion, IFNB-1b modulates the adhesion cascade in patients with PPMS in a similar way it does in RRMS. Nevertheless, a clinical effect of IFNB in PPMS still has to be proven in a randomized controlled clinical trial.     

Endermology: a treatment for injection-induced lipoatrophy in multiple sclerosis patients treated with sub cutaneous glatiramer acetate

Objective

To evaluate sessions of endermology (LPG) on patients with lipoatrophy, due to GA injections in an open-labelled study.

Background

Glatiramer acetate (GA) is an immunomodulatory drug, with an excellent safety profile, that is currently used for treatment of multiple sclerosis and is administered as daily subcutaneous injections of 20 mg. The most common adverse effects, which occur in approximately 20–60% of the patients, include pain, inflammation and induration at the injection sites. Another adverse effect is frank panniculitis followed by localized lipoatrophy at the injection sites, which has been described in half of the patients receiving treatment with glatiramer acetate injections. No treatment has been found for established lipoatrophy.

Patients and methods

All patients underwent LPG twice a week during 30 min. A cycle of two months was initially proposed. If the patient was satisfied with the result, sessions were continued with one session per week until the 4th month.

Results

Eight Patients treated with GA and presenting with lipoatrophy were prospectively recruited. None of them complained of any adverse events. After 8 weeks of treatment, all had a visible reduction of lipoatrophic area. MRI showed no major subcutaneous changes except for a reduction in and repartition of fatty tissues.

Conclusion

The LPG cellu M6 keymodule is a mechanotransduction machine that stimulates the skin's surface in triggering cells to activate lipolysis and collagen production. It has never been used for treatment of lipoatrophy due to drug treatment or in specific diseases associated with lipoatrophy (diabetes, HIV). The prevention and management of lipoatrophy includes patient education, regular examination and manual palpation of all injection sites. LPG endermology can help patients to resolve this side effect and to continue immunomodulatory treatment.     

Combination therapy with interferon beta-1b and azathioprine in secondary progressive multiple sclerosis. A two-year pilot study

Combination therapy may benefit the subgroup of patients with secondary progressive multiple sclerosis (SPMS) who do not respond to interferon beta (IFNB). We performed a two-year study of azathioprine (AZA) combined with IFNB-1b in SPMS patients who had not responded well to IFNB-1b alone. Patients with SPMS were eligible for this non-controlled prospective study if they had two or more relapses requiring corticosteroid treatment or deteriorated by at least 0.5 points on the Expanded Disability Status Scale (EDSS) while on IFNB-1b in the year preceeding the study. Patients were to continue treatment with IFNB-1b (8 MIU qod, subcutaneous) and received AZA (50 mg tid, oral). Safety was assessed in terms of adverse reactions and laboratory measures graded according to the WHO toxicity scale. Efficacy was explored by changes in relapse rate, EDSS, 9-hole peg test (9-HPT), neuropsychological scores, and magnetic resonance imaging (MRI) results. Neutralizing antibodies (NAB) were measured. Ten SPMS patients (6 females) with a median EDSS score of 4.5 were enrolled. One patient withdrew because of gastrointestinal complaints, one was withdrawn owing to poor compliance, and 8 patients completed therapy. The only frequent side effect was lymphopenia, reported at least once in all patients. Annual relapse rate was reduced by approximately 50 % in the second year. There was a significant trend for EDSS increase. Total lesion load measured by MRI decreased at 12 and 24 months; only one patient had active lesions. No changes were seen in the 9-HPT. There was a significant improvement in neuropsychological tests after 24 months (p = 0.045). One patient tested positive for NAB throughout the study, and transient NAB were detected in 4 patients. In conclusion, combination therapy with IFNB-1b and AZA was safe and generally well tolerated in patients with SPMS. Strict clinical and laboratory monitoring is recommended during this combination therapy. Received: 26 November 2001 Received in revised form: 15 February 2002 Accepted: 19 February 2002     

Comparative studies of glatiramer acetate and interferon beta

Over the last decade and a half, several disease-modifying therapies (DMTs) have been approved for the treatment of multiple sclerosis (MS) including glatiramer actetate (GA; Copaxone), interferon beta (IFNB)-1a (Avonex, Rebif), IFNB-1b (Betaferon/Betaseron), mitoxantrone (Novantrone), and natalizumab (Tysabri). Randomized controlled trials (RCTs) of each of these DMTs have demonstrated that treatment has a favourable impact on at least one (often several) of the short-term outcome measures typically used to assess efficacy in MS clinical trials. These outcomes include clinical measures of disease activity such as the number or frequency of relapses, the time to first relapse, etc. They also include clinical measures of disease severity such as disease progression on the Expanded Disability Status Scale (EDSS) or the MS Functional Composite score (MSFC), determined either as a confirmed change over a 3 to 6 month interval or as a total change over the entire duration of the trial, in addition to various magnetic resonance imaging (MRI) measures such as the number and volume of T2 lesions, the number and volume of new or gadolinium (Gd)-enhancing lesions, or the number and volume of T1 dark lesions.     

Management of cutaneous type IV hypersensitivity reactions induced by heparin

Localized hypersensitivity reactions to subcutaneous heparin injections have been described since 1952. Yet, the incidence of these reactions, which are distinct from skin lesions associated with heparin-induced thrombocytopenia type II (HIT II), remains uncertain. However, in the last 10 years an increasing number of patients have been reported, leading to the assumption that cutaneous hypersensitivity reactions towards heparin are underreported. Clinically patients present with itching, sometimes infiltrated, and blistering erythemas at the injection sites of heparins. The diagnosis of cutaneous heparin allergy may, on the one hand, lead to delay of required medical or surgical treatment. On the other hand, delayed initiation of treatment may lead to a generalized eczematous reaction. Hence, from review of 223 cases of patients with cutaneous hypersensitivity reactions to heparin, we here summarize the clinical picture of cutaneous type IV allergic reactions, define risk factors on both the patient- and drug-side, and give an overview of principle therapeutic alternatives, as well as recommendations for treatment options for emergency and elective patients. As the proposed management of patients with cutaneous hypersensitivity reactions to heparin may have fatal consequences when applied in patients with HIT type II, diagnosis of skin lesions in heparin-treated patients needs to be precise.     

Different responses to interferon beta‐1b treatment in patients with neuromyelitis optica and multiple sclerosis

Background: Although the benefit of treatment for relapsing–remitting multiple sclerosis (MS) is firmly established, whether interferon beta‐1b (IFNB‐1b) therapy is efficacious for neuromyelitis optica (NMO) has been debated. Methods: We reviewed the responses to IFNB‐1b treatment in 18 patients with relapsing NMO and compared the results with those from 38 patients with relapsing–remitting MS. We compared clinical characteristics, the annualized relapse rate (ARR) and the probability of being relapse free before and after IFNB‐1b treatment in patients with NMO and MS. Results: The proportion of patients with more than 50% increase in the ARR after IFNB‐1b treatment was much higher in NMO than in MS (P = 0.046). ARR was significantly lower in patients with MS after IFNB‐1b administration than before (P = 0.015), but not in NMO. Kaplan–Meier and log‐rank statistical analyses revealed that relapse‐free rates were lower in NMO than MS after IFNB‐1b treatment (P = 0.032). The analyses also showed lower relapse‐free rates during the pre‐IFNB‐1b treatment period than the post‐IFNB‐1b treatment period in MS (P < 0.001), but not in NMO. Conclusion: IFNB‐1b treatment does not appear to be effective for preventing relapse in NMO likely because of differences between the immune‐pathogenesis of NMO and MS.     

MS Forum/MS Over the Past 17 Years

At its final meeting, the MS Forum Executive Committee reviewed highlights of where things stood prior to the immunomodulatory era, and how things have evolved subsequently. What the future might hold was discussed in a second session. Prior to 1990: Genetic predisposition to multiple sclerosis (MS), as determined by human leukocyte antigen expression, was established and an environmental trigger (Epstein-Barr virus?) was suspected, as was lack of sunshine. Substantial evidence for activated T-cells as relapse initiators had accumulated. Defective regulatory cell function that correlated with disease activity was shown. Adrenocorticotropic hormone lessened relapse severity as did its steroid replacement. A trial of cyclosporine, a T-cell inhibitor, in progressive MS failed. The drug, not the patients chosen, was blamed. 1990-2010: Approval of interferon-beta (IFNB)-1b was followed promptly by IFNB-1a, glatiramer acetate, mitoxantrone and then by natalizumab and fingolimod. All reduce MS attack frequency and new lesion accumulation. None have reduced disability progression in progressive MS. Brain atrophy, cognitive loss and axonal interruption in progressive MS depend on innate immune system activation rather than on T-cells. New strategies are needed.     

Cutaneous vasculitis with renal impairment complicating interferon-beta 1a therapy for multiple sclerosis

INTRODUCTION: Cutaneous tolerance of the interferon beta used in the treatment of relapsing-remitting multiple sclerosis is good. However, among the rare adverse effects, vasculitis and glomerular impairment have been described for interferon beta-1b. CASE REPORT: A 36-year-old woman had been given subcutaneous injections of interferon beta 1-1a (Rebif, Serono) three times a week for ten weeks. A local transient cutaneous erythema was observed at the injection's sites. A few days after a new injection a erythematous plaques developed at the injection sites followed by pruritus, then purpura with edema on the leg in addition to an increase in body weight of 3 kg. Biological data showed proteinuria and hematuria. The histology study of skin specimens suggested non-specific lymphocytic vasculitis. Outcome was favorable after discontinuing interferon beta-1a. CONCLUSION: The etiology of the cutaneous and renal impairment is not formally established but the drug-induced hypothesis is proposed for interferon beta-1a.     

Interferon beta-1b exacerbates multiple sclerosis with severe optic nerve and spinal cord demyelination

To evaluate the effect of interferon beta-1b (IFNB-1b) on multiple sclerosis (MS) with severe optic nerve and spinal cord demyelination, we examined the relationship between IFNB-1b treatment outcome and the clinical and genetic characteristics of three types of demyelinating diseases of the central nervous system, i.e., neuromyelitis optica (NMO), MS and MS with severe optic-spinal demyelination. Japanese MS frequently carried HLA DPB1*0501, which is associated with NMO. MS with DPB1*0501 showed severe optic-spinal demyelination represented by longitudinally extensive spinal cord lesion, blindness and CSF pleocytosis. IFNB-1b treatment did not succeed in these patients because of the increase of optic nerve and spinal cord relapse and other severe side effects. IFNB-1b should not be administered to demyelinating patients with genetic and clinical characteristics mimicking NMO such as HLA DPB1*0501 allele, longitudinally extensive spinal cord lesion, blindness and CSF pleocytosis even if they have symptomatic cerebral lesions as typically seen in MS. The present study strongly suggests that these patients should be diagnosed as having NMO.     

Oral interferon beta-1a in relapsing-remitting multiple sclerosis: a double-blind randomized study

BACKGROUND: Interferon beta (IFNB) is available in parenteral formulations for treatment of multiple sclerosis (MS). The purpose of this study was to evaluate safety, tolerability and effects on MRI lesions of three different doses of oral IFNB-1a compared with placebo over six months in relapsing-remitting (RR) MS patients. METHODS: In this multicenter; double-blind randomized trial, RR-MS patients received 0.06, 0.6 or 6 million international units (MIU) IFNB-1a or placebo every other day for up to six months. Gadolinium DTPA-enhanced brain MRI scans were performed at screening and monthly during treatment. The primary variable was the cumulative number of newly active lesions. Secondary variables included volume of enhancing lesions on T1-weighted images each month and lesion volume on T2-weighted images at months three and six. Safety measures included adverse events, laboratory variables, vital signs, ECG, physical examination, EDSS and number of relapses. Neopterin was measured in 21 patients and neutralizing antibodies in 24 patients. RESULTS: Of 194 screened patients, 173 were randomized (42-44 patients per group) in 15 centers. Median cumulative numbers of newly active lesions over six months were 4.0 in the placebo and 0.6 MIU groups, compared with 7.5 and 9.0 in the 0.06 and 6 MIU groups (no significant differences). Secondary efficacy endpoints showed small and inconsistent differences between groups. Adverse events showed no notable group differences. Approximately two-thirds of patients in each group remained relapse free. No patients showed neutralizing antibodies. Neopterin levels were comparable between groups. CONCLUSION: Oral IFNB-1a showed neither beneficial effects in RRMS nor any systemic biological effects. Treatment was safe and well tolerated.     

Lobular panniculitis and lipoatrophy of the thighs with interferon-ß1a for intramuscular injection in a patient with multiple sclerosis

Multiple sclerosis (MS) patients may experience severe local inflammatory skin reactions during disease-modifying therapy with subcutaneously injected interferon-β (IFN-β). It is common clinical practice to switch those patients to an intramuscularly administered formulation, where severe local skin reactions have not been described. Here we report a 42-year-old woman with stable relapsing–remitting MS, who was switched from subcutaneously to intramuscularly injected IFN-β1a due to abdominal skin necroses and slight multifocal lipoatrophy. After two years of complication-free therapy with intramuscular IFN-β1a, the patient slowly developed painful lobular panniculitis and severe lipoatrophy of both lateral thighs. A careful diagnostic workup identified misguided subcutaneous injections due to a wrong injection angle as the most plausible cause. Upon correction of her injection technique, pain and skin reddening resolved, while her disfiguring lipoatrophy was irreversible. This report should enhance awareness that severe skin adverse effects may also occur, although rarely, with IFN-β for intramuscular injection. Early recognition and correction of the injection technique may help to prevent severe complications.     

Interferon β bei Multipler Sklerose

Interferon?β-1b (IFNB-1b, Betaferon?) was the first therapy for multiple sclerosis (MS) showing efficacy in a randomized controlled clinical trial. Early studies suggested a dose-dependency of the clinical efficacy of IFNB-1b. However, until recently no reliable clinical data were available to assess the potential of higher dosing to increase therapeutic efficacy. In addition, no clinical trials have been conducted to directly compare the efficacy of IFNB-1b with that of glatiramer acetate, an alternative first line treatment option for relapsing-remitting MS. Just recently, the prospective, randomized, multicenter study BEYOND was published which addressed both issues. In this review the BEYOND trial is reviewed and placed in the context of advantages and disadvantages of currently available first line therapies for MS.     

Autoimmune events during interferon beta-1b treatment for multiple sclerosis

Autoimmune events, although rarely reported during interferon beta-1b (IFNB) treatment of relapsing-remitting (RR) multiple sclerosis (MS), may be more frequent than expected due to the many immunologic abnormalities associated with this disease. We report the prospective two-year follow-up of autoimmune events in 40 RR MS patients treated with IFNB and in 21 untreated MS controls. Thyroid and liver function and serum level of 12 autoantibodies (autoAbs) against organ- (thyroid, gastric, pancreatic) and non-organ-specific antigens were serially monitored. In contrast to control patients, autoAbs (anti-nuclear, -smooth muscle or -thyroid antigens) were detected in 13 IFNB-treated patients, and these were associated with thyroid or liver function alteration in many cases. Persistent autoimmune thyroid dysfunction occurred in three IFNB-treated patients, all of whom were women with a familial history of thyroid disease or baseline anti-thyroid autoAb positivity. For improvement of the MS relapse rate, thyroid dysfunction was adequately treated without stopping IFNB. Liver function alteration (17 IFNB-treated patients, associated with non-organ-specific autoAbs in four) was transient and did not require IFNB treatment to be stopped, with the exception of one patient who was already suffering from a drug-induced hepatopathy at baseline. During the IFNB treatment of MS, several autoimmune events may occur, indicating that thyroid and liver function and autoAbs must be carefully monitored.     

Lessons from 10 years of interferon beta-1b (Betaferon/Betaseron) treatment

In 1993, interferon beta-1b (IFN beta-1b, Betaferon/Betaseron) was the first interferon approved in the USA for relapsing-remitting multiple sclerosis (RRMS). Since then, dose-dependent effects of IFN beta in MS have been extensively discussed. Such effects had already been observed in the pivotal trial and were followed by dose comparison trials with IFN beta-1a. Later, the therapeutic efficacy of IFN beta-1b could also be demonstrated in secondary progressive (SP) MS patients. We learnt from further studies that benefit from IFN beta in SPMS seems to be most pronounced in those patients still having active disease with superimposed relapses or clear progression. The most common IFN beta-related adverse events, especially in the early treatment phase, have been flu-like symptoms and injection-site reactions. The consequent management of those as well as of other, less frequent, side-effects turned out to be of tremendous importance to ensure patients' compliance. Based on the experience of 10 years, IFN beta-1b belongs to the firstline therapeutics in RR and SPMS.     

Cognitive dysfunction in patients with multiple sclerosis treated with first-line disease-modifying therapy: a multi-center,controlled study using the BICAMS battery

Multiple sclerosis (MS) can impair cognitive functions even in the early stages. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery is very short and highly sensitive and can be used to evaluate cognitive status in the disease. Several clinical trials have shown beneficial effects of disease-modifying drugs (DMDs) on long-term cognitive measures which may even reduce cognitive deficits in MS patients. Relapsing remitting MS patients using DMDs were enrolled in the study and monitored for 12 months. BICAMS and the Expanded Disability Status Scale were applied to the study group. We evaluated and monitored 161 newly diagnosed cases of definite MS by the end of the trial. 110 patients (68.2%) were female. One hundred and two healthy subjects (female to male ratio 68:34) were enrolled into the study. MS patients were categorized into three DMT groups: IFNB1-a SC, IFNB1-b, and GA. Mean scores of all three cognitive tests (SDMT, BVMT-R, and CVLT-II) were significantly higher in the control group than in the MS patients. The number of cognitively impaired patients decreased from 31.7 to 21.7% on the basis of CVLT (p = 0.024), and 42 (26.1%) to 30 (18.6%) on the basis of BVMT-R at month 12. A significant difference was determined in terms of cognitive status between MS patients using both IFNB and GA and the healthy control group. Ours is the first study to compare IFNB and GA in terms of evaluating cognitive involvement and to use the BICAMS battery in monitoring treatment.     

Autoimmune hemolytic anemia during interferon-beta-I b treatment for multiple sclerosis

A 31-year-old patient with multiple sclerosis (MS), treated with interferon beta-1b (IFNB-1b) for two years, presented with fatigue and dizziness. Coombs' positive autoimmune hemolytic anemia (AIHA) was found. Other potential etiologies of AIHA were ruled out. An association with IFNB-1b was highly suspected. Interferon therapy was discontinued and prednisone therapy instituted. There was resolution of the hemolytic anemia, and prednisone therapy was tapered gradually. To the best of our knowledge, there is no reported case of the development of AIHA associated with IFNB-1b use in MS patients. We conclude that if an unexplained drop in hematocrit occurs with a MS patient receiving IFNB-1b, autoimmune mediated hemolysis should also be considered.     

Reduction of injection site reactions in multiple sclerosis (MS) patients newly started on interferon beta 1b therapy with two different devices

OBJECTIVES: To compare occurrence of injection site reactions (ISRs) in patients with relapsing remitting multiple sclerosis (RRMS) newly started on interferon beta 1b (Betaferon), using 3 delivery methods. STUDY DESIGN: A randomized, multicenter, phase IV, open label cross-over study was performed in 82 sites in France on 294 patients with RRMS beginning a treatment with interferon beta 1b. For the first month all patients used a standard injection technique. They then used an autoinjector, Betaject or Betaject Light, for one month each, according to the cross-over design. Primary outcome was defined as the percentage of injections sites with ISR evaluated by the investigator. Secondary endpoints included graduation of ISR, using a five-point scale by both investigators and patients, injection related pain assessed by patients, percentage of patients without ISR and a global evaluation by patients of injection devices. RESULTS: The percentage of ISRs were significantly reduced (p<0.0001) when using either Betaject or Betaject light (24.1 percent and 24.1 percent respectively) compared with the standard technique (35.9 percent). No significant difference was seen between the 2 autoinjectors. The mean ISR intensity scores according to physician or patient were significantly reduced (p<0.0001 for each) by the 2 autoinjectors compared to the standard injection technique. No significant difference on the pain scale comparing respectively the standard, Betaject and Betaject light techniques but the mean level of pain was less than 1.2/10. In addition, the percentage of ISR-free patients was significantly lower with the standard injection technique phase (52.4 percent) than with autoinjector use (respectively 68.1 and 66.7 percent). A non significant higher percentage of patients subjectively preferred Betaject (53.7 percent) than to Betaject light (46.3 percent). The main other adverse events reported were flu-like symptoms (30.7 percent), transient and moderate increase of transaminases (4.8 percent) and headache (4.4 percent). CONCLUSION: We conclude that autoinjector use reduces the occurrence of ISR during IFNB-1b therapy in RRMS.     

Economic evaluation of treating clinically isolated syndrome and subsequent multiple sclerosis with interferon β-1b

New therapeutic options have modified the natural history and health care costs of multiple sclerosis (MS). An epidemiological 25 years-long model-based cost-utility analysis was performed following the Italian National Health Service (INHS) and societal perspectives to compare costs and quality-adjusted life years of treatment with Interferon β-1b (IFNB-1b) from diagnosis of clinically isolated syndrome (CIS) versus treating at subsequent conversion to clinically definite MS (CDMS). Among patients treated (untreated) with IFNB-1b from CIS diagnosis, 40,420 (43,700) converted to CDMS after 25 years; the estimated cumulative probability of converting to CDMS during the first 3 years was 72.90% (84.94%) (P < 0.0001). Early treatment with IFNB-1b is highly cost-effective for the INHS (incremental cost-effectiveness ratio: Euros 2,574.94) and dominant from the societal viewpoint. Sensitivity analyses confirmed the base case findings. Early treatment with IFNB-1b delays conversion to CDMS in CIS patients and might be a “good value for money” health care programme.     

Treatment with interferon beta-1b improves quality of life in multiple sclerosis

BACKGROUND: The Canadian Burden of Illness Study Group reported that the quality of life (QoL) of multiple sclerosis (MS) patients falls drastically, early in the disease. With disability progression, the physical functioning scales of the Short Form 36 (SF-36) showed further decreases in QoL. The objective of this study is to describe the QoL of MS patients treated with interferon beta-1b (IFNB-1b) and to compare it to the QoL observed in a group of patients who had not been treated with IFNB-1b. METHODS: Treated patients were prospectively recruited and were seen at their regular visit to the MS clinic. They self-completed the SF-36 questionnaire and their QoL was described and retrospectively compared to that of historical controls. RESULTS: When IFNB-1b treated patients were compared to historical control patients with the same relapsing forms of MS, the treated patients with an Expanded Disability Status Scale (EDSS) score lower than 3.0 had a significantly better QoL. This was significant for four of the eight SF-36 domains: Physical Function (+22%, p = 0.0102), Role-Physical (+100%, p = 0.0022), General Health (+27%, p = 0.0070) and Social Function (+19%, p = 0.0287). The average QoL difference was 8% in the EDSS 3.0-6.0 group and 10% in the EDSS > 6 group. CONCLUSION: Patients with relapsing forms of MS treated with IFNB-1b have better QoL than patients who are not treated, especially those with an EDSS < 3.0.