Likewise, 12 and 24 months, Expanded Disability Status

Likewise, the overall treatment satisfaction rating
(scale range: 1–7), significantly improved from a mean of 4.8, with injectable
therapies, to a mean of 6.3 after 1 year of rituximab treatment, which remains sustained
by 2 years. There was no significant alteration in scores for the patient-perceived impact of disease, fatigue or
disease progression 13. In a comparative study, a total of 461 patients from
the Swedish MS registry in the rituximab arm and 922 patients from the IFN-?/GA
arm in RRMS were compared 14. The results were indicative of a significant reduction in Annualized Relapse Rate (ARR)
associated with rituximab use. In addition, rituximab was associated with an
87% decrease in the relapse rate and a discontinuation rate reduction by 85%
relative to IFN-?/GA. When examined at 12 and 24
months, Expanded Disability Status Scale (EDSS) was significantly regressed (improved) from baseline in the rituximab
group. In contrast, the OLYMPUS trial which is a phase II/III trial, enrolled
439 patients with PPMS and followed them for 96 weeks, failed to show any
reduction in disease progression during follow up period 15. However, when
looking at subgroups of patients younger than 50 years
or regarding the Gadolinium-enhanced lesions at baseline, a significant effect was detected 15.

An observational study
of three SPMS patients who were treated with rituximab for at least 15
months showed that EDSS score stabilized in all patients after a dramatic increase
over the previous year’s 16. Finally, a retrospective observational report of
822 Swedish patients with MS, including 557 RRMS, 67 PPMS and 198 SPMS who were
treated with intravenous rituximab (500 or 1000 mg every 6 to 12 months) for a
mean duration of 22 months showed that patients with RRMS had a low mean yearly
relapse rate (0.04) during rituximab treatment and their median disability
status remained unchanged. Patients with PPMS had a low mean annualized relapse
rate (0.015) during rituximab therapy and their median disability status increased.
Patients with SPMS had a low mean annualized relapse rate (0.038) and their
median disability status increased. Infections were the most common non
infusion-related adverse event of rituximab 17.

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According to available studies, rituximab might be
an effective treatment option in patients with RRMS and possibly in a subset of
PPMS patients, but due to licensing issues the study was not further conducted for the treatment of MS 18, 19.  These results suggest that although several research has been carried out, decisions making regarding the use of
rituximab in MS based on available evidence is
difficult at the moment and especially when there are requests for off label uses. Particularly in our study, most
patients who received rituximab for the treatment
of MS, were suffering from SPMS on which available studies are limited.

Although some studies suggest that rituximab can
contribute to the improvement of skin and articular involvement, and possibly
the pulmonary fibrosis of systemic sclerosis (SSc), most of these studies are
case reports or open label studies 20-34. SSc is a connective
tissue disorder with a chronic and frequently progressive course. Patients with SSc can
be roughly grouped into diffuse cutaneous and limited cutaneous subsets regarding
the pattern of skin involvement,
clinical and laboratory features. Recently, the European Scleroderma Trial and
Research (EUSTAR) cohort compared the two groups of rituximab treated and
untreated match–control SSc patients and demonstrated that improvement of skin
?brosis could prevent worsening lung ?brosis. These findings support the
concept of B cell inhibition in the treatment of SSc. Although, this study is
the largest case- control study available so far, and although it adds
important aspects to rituximab and other B cell targeting therapies in general
and as a potential anti?brotic treatment strategy in SSc; this might not be
conclusive as it is not a randomized controlled trial and couldn’t precisely
explain the ef?cacy and relative safety of rituximab on skin and lung ?brosis
in SSc as compared with placebo treatment 32. Similarly, Update of EULAR
recommendations emphasizes on several (potential) drugs, including new
promising therapies that might be helpful in the management of patients with
SSc that could not be included in these evidence-based recommendations due to
insufficient data at present 35.

There are evidence
that rituximab treatment in patients with resistant idiopathic inflammatory
myopathies has some benefits 36. Idiopathic inflammatory myopathies (IIMs) are a
group of acquired, heterogeneous, systemic diseases of skeletal muscle,
including adult Polymyositis (PM) and Dermatomyositis (DM), Juvenile DM (JDM)
and PM (JPM), Anti-Synthetase Syndrome (ASS) and IBM. PM
and DM are two major and discrete subtypes of IIMs which present with
involvement of skeletal muscles, the skin and other organs 36, 37. B cells
play a critical role in the initiation and progression of the immune response
which has been suggested to be involved
in the pathogenesis of myositis. Considering the likelihood of pathogenetic
role of B cells in myositis, rituximab may have a role in the treatment of
myositis in several studies 36. A large clinical trial Rituximab in Myositis (RIM), randomized 200 patients with refractory
myositis (76 with PM, 76 with DM and 48 with JDM) to receive different regimens
of rituximab (two infusions at baseline or 8 weeks later).