Azulfidine (Sulfasalazine) - Summary

AZULFIDINE SUMMARY

Azulfidine^®
sulfasalazine tablets, USP

AZULFIDINE Tablets contain sulfasalazine, 500 mg, for oral administration. Therapeutic Classification: Anti-inflammatory agent. Chemical Designation: 5-([p-(2-pyridylsulfamoyl)phenyl]azo) salicylic acid. Chemical Structure:

AZULFIDINE Tablets are indicated:

• a)in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; and
• b)for the prolongation of the remission period between acute attacks of ulcerative colitis.

NEWS HIGHLIGHTS

Published Studies Related to Azulfidine (Sulfasalazine)

Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial. [2009.08.18]
BACKGROUND: Extracts of the medicinal plant Tripterygium wilfordii Hook F (TwHF) have been used in China for centuries to treat a spectrum of inflammatory diseases. OBJECTIVE: To compare the benefits and side effects of TwHF extract with those of sulfasalazine for the treatment of active rheumatoid arthritis... CONCLUSION: In patients who continued treatment for 24 weeks and could also use stable oral prednisone and nonsteroidal anti-inflammatory drugs, attainment of the ACR 20 response criteria was significantly greater with TwHF extract than with sulfasalazine.

Addition of infliximab compared with addition of sulfasalazine and hydroxychloroquine to methotrexate in patients with early rheumatoid arthritis (Swefot trial): 1-year results of a randomised trial. [2009.08.08]
BACKGROUND: New treatment strategies for early rheumatoid arthritis are evolving rapidly. We aimed to compare addition of conventional disease-modifying antirheumatic drugs (sulfasalazine and hydroxychloroquine) with addition of a tumour necrosis factor antagonist (infliximab) to methotrexate in patients with early rheumatoid arthritis... INTERPRETATION: In patients with early rheumatoid arthritis in whom methotrexate treatment failed, addition of a tumour necrosis factor antagonist to methotrexate monotherapy is clinically superior to addition of conventional disease-modifying antirheumatic drugs. FUNDING: Swedish Rheumatism Association, Schering-Plough.

Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year study. [2009.07]
OBJECTIVE: To determine the efficacy and safety of etanercept and etanercept plus sulfasalazine versus sulfasalazine in patients with rheumatoid arthritis (RA) despite sulfasalazine therapy... CONCLUSION: Etanercept and etanercept plus sulfasalazine are efficacious for the long-term management of patients with RA. The addition of etanercept or substitution with etanercept should be considered as treatment options for patients not adequately responding to sulfasalazine.

A randomized controlled trial of early intervention with intraarticular corticosteroids followed by sulfasalazine versus conservative treatment in early oligoarthritis. [2007.02.15]
OBJECTIVE: To determine the outcome after 52 weeks of early intervention with intraarticular corticosteroid injections followed by sulfasalazine versus conservative therapy in patients with recent-onset oligoarthritis in a randomized controlled trial... CONCLUSION: Oligoarthritis has a significant impact on function and work ability. Patients treated with EI using intraarticular corticosteroids followed by sulfasalazine therapy if resistant demonstrated reduced synovitis 12 months after treatment compared with those initially treated with more conservative therapy.

A randomized controlled trial of early intervention with intraarticular corticosteroids followed by sulfasalazine versus conservative treatment in early oligoarthritis. [2007.01.31]
OBJECTIVE: To determine the outcome after 52 weeks of early intervention with intraarticular corticosteroid injections followed by sulfasalazine versus conservative therapy in patients with recent-onset oligoarthritis in a randomized controlled trial... CONCLUSION: Oligoarthritis has a significant impact on function and work ability. Patients treated with EI using intraarticular corticosteroids followed by sulfasalazine therapy if resistant demonstrated reduced synovitis 12 months after treatment compared with those initially treated with more conservative therapy.

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Clinical Trials Related to Azulfidine (Sulfasalazine)

Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis [Active, not recruiting]
The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.

Study To Determine The Pharmacokinetics Of Sulfasalazine In Children With Juvenile Idiopathic Arthritis [Recruiting]
This study will characterize the steady state pharmacokinetics of sulfasalazine delayed release tablets in pediatric Juvenile Idiopathic Arthritis patients. Data from this study will fulfill the post approval commitment to the FDA.

Sulfasalazine and Endothelial Function [Completed]
Experimental studies suggest that systemic inflammation leads to endothelial dysfunction and atherosclerosis. This study will examine the effects of the anti-inflammatory drug sulfasalazine on endothelial function in patients with coronary artery disease. Subjects will be treated with sulfasalazine or to placebo for six weeks. After a two-week rest period, subjects will cross over to the alternative treatment. Endothelium-dependent flow-mediated dilation of the brachial artery will be studied before and after each drug. We hypothesize that anti-inflammatory therapy will reverse endothelial dysfunction in patients with coronary artery disease.

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis [Recruiting]

Enbrel-Sulfasalazin-Early-Axial Spondyloarthritis (AS) [Recruiting]

Efficacy - To assess efficacy of etanercept versus sulfasalazine when added to NSAIDs in

patients with moderate to severe active early axial spondyloarthritis duration of ongoing axial symptoms of less than 5 years. Primary outcome is change of active inflammatory lesions in sacroiliac joints and spine as detected by MRI at 12 months. Secondary outcome parameters are clinical and laboratory efficacy parameters and MRI changes at 6 months and 2 years. Comparisons will be made within the two treatment arms and compared to baseline. At the 1 year extension phase comparisons will be also made between year 1 and year 2. At the end of the extended study a pelvic x-ray is planned.

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PATIENT REVIEWS / RATINGS / COMMENTS

Azulfidine review by 49 year old male patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		colitis
Dosage & duration:		1000 mg taken 3 times a day for the period of oral (tablets)
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		reduced bleeding and inflamation initially, then less bloating, diareaha and nausea.
Side effects:		some sunlight sensitivity (sunburn more easily) and reduced sperm count.
Comments:		began with two 500mg tablets three times a day by mouth. reduced to twice a day after six months. symptoms gradually subsided in the first three months. on maintenance dose currently.