AZASAN®, an immunosuppressive antimetabolite, is available in tablet form for oral administration.
AZASAN® is indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of severe, active rheumatoid arthritis unresponsive to rest, aspirin, or other nonsteroidal anti-inflammatory drugs, or to agents in the class of which gold is an example.
Renal Homotransplantation: AZASAN® is indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor and anti B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials.
Rheumatoid Arthritis: AZASAN® is indicated only in adult patients meeting criteria for classic or definite rheumatoid arthritis as specified by the American Rheumatism Association. AZASAN® should be restricted to patients with severe, active and erosive disease not responsive to conventional management including rest, aspirin, or other nonsteroidal drugs or to agents in the class of which gold is an example. Rest, physiotherapy, and salicylates should be continued while AZASAN® is given, but it may be possible to reduce the dose of corticosteroids in patients on AZASAN®. The combined use of AZASAN® with gold, antimalarials, or penicillamine has not been studied for either added benefit or unexpected adverse effects. The use of AZASAN® with these agents cannot be recommended.
Published Studies Related to Azasan (Azathioprine)
Interferon, azathioprine and corticosteroids in multiple sclerosis: 6-year
follow-up of the ASA cohort. 
combined with low-dose azathioprine and prednisone in multiple sclerosis... CONCLUSION: The tested combined therapeutic regimen does not improve long-term
A randomized trial of methotrexate versus azathioprine for severe atopic eczema. [2011.08]
BACKGROUND: Patients with severe atopic eczema frequently require systemic treatment to control their disease. Methotrexate and azathioprine are proposed as off-label treatment options, but direct comparisons are lacking. OBJECTIVES: We sought to compare the efficacy and safety of methotrexate versus azathioprine in adults with severe atopic eczema... CONCLUSION: Both treatments achieved clinically relevant improvement and were safe in the short term. Methotrexate and azathioprine are appropriate options for the treatment of severe atopic eczema. Copyright (c) 2011 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
A pragmatic randomized controlled trial of thiopurine methyltransferase genotyping prior to azathioprine treatment: the TARGET study. [2011.06]
AIM: To conduct a pragmatic, randomized controlled trial to assess whether thiopurine methyltransferase (TPMT) genotyping prior to azathioprine reduces adverse drug reactions (ADRs)... CONCLUSION: Our work supports the strong evidence that individuals with TPMT variant homozygosity are at high risk of severe neutropenia, whereas TPMT heterozygotes are not at increased risk of ADRs at standard doses of azathioprine.
Steroids and azathioprine in the treatment of IgA nephropathy. [2011.06]
AIM: IgA nephropathy (IgAN) is a very common glomerulonephritis among young adults, but the best therapeutic approach has not been fully elucidated. This study evaluated the effect of two different treatment regimes in IgAN, steroids alone or in combination with azathioprine... CONCLUSIONS: Both, steroid treatment alone and steroids in combination with azathioprine seem to be effective in reducing the severity of proteinuria and stabilizing renal function in IgAN. Patients who do not respond to steroids may have a better response with the combination of steroids and azathioprine.
Cyclosporine versus azathioprine therapy in high-risk idiopathic membranous nephropathy patients: A 3-year prospective study. [2011.03]
There is no consensus regarding the modality of therapy for idiopathic membranous nephropathy (IMN), especially for patients who did not react to treatment with cytotoxic drugs. This study followed prospectively for 3-year IMN patients who did not react to Ponticelli protocol comparing effects of 2-year course of cyclosporine (CsA) with azathioprine (Aza) treatment both with small doses of prednisolone...
Clinical Trials Related to Azasan (Azathioprine)
Azathioprine & Allopurinol in Inflammatory Bowel Disease Patients [Recruiting]
Azathioprine Versus Placebo in Pemphigus Vulgaris Treated With Prednisolone [Not yet recruiting]
Description: Pemphigus vulgaris is an autoimmune, chronic and recurrent blistering disease
with unknown etiology that affects mucosa and skin of patients with significant morbidity
The treatment back-bone is based on prednisolone administration. There are controversies on
the opportunity of adding immunosuppressive drugs. For some, they are just corticosteroid
sparing drugs. For others, they are disease modifying drugs.
The purpose of this trial is to compare efficacy and safety of azathioprine vs. placebo in
new cases of pemphigus vulgaris treated with prednisolone.
Rituximab Vasculitis Maintenance Study [Not yet recruiting]
Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody
(ANCA) vasculitis following major European and US trials reported in 2010. After a time, its
effect wears off and the disease can return. This occurs in at least half of patients within
2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that
repeating rituximab every six months stops the disease returning and is safe.
The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and
whether it works better than the older treatments, azathioprine or methotrexate. It will
also tell us how long patients remain well after the repeated rituximab treatments are
stopped, and if repeated rituximab is safe. We should also learn useful information about
the effects of rituximab on quality of life and economic measures. The trial results will
help decide the best treatment for future patients who have their vasculitis initially
treated with rituximab.
RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come
back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we
anticipate that most will respond well. If their disease is under reasonable control after
four months, further treatment with either rituximab (a single dose ever four months for two
years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and
azathioprine groups will then be compared. Patients will be in the trial for four years.
The study has been designed by members of the European Vasculitis Study group (EUVAS) and
the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30
hospitals in Europe, the USA, Australia and Mexico.
RITAZAREM is being funded by Arthritis Research UK, the U. S. National Institutes of Health
and by Roche/Genentech.
Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis [Recruiting]
Myfortic Versus Azathioprine in Systemic Lupus Erythematosus [Recruiting]
This study is designed to explore the use of myfortic ® in patients with active lupus
erythematosus. Similar drugs in this class are increasingly used in organ transplantation
and in autoimmune diseases. With the established safety profile of myfortic ® in
allo-transplantation and the already existing data of mycophenolate mofetil in autoimmune
diseases, this study should help to demonstrate the beneficial effect of myfortic ® on lupus
activity. The aim of the study will be to show a decreased disease activity with myfortic ®
compared to standard maintenance therapy with azathioprine.