Sulfasalazine (Sulfasalazine) - Summary

SULFASALAZINE SUMMARY

Sulfasalazine
Tablets USP
Rev: December 2003
Rx only

Sulfasalazine Tablets USP, 500 mg for Oral Administration Therapeutic classification: Anti-inflammatory agent. Chemical designation: 5-[[ p -(2-Pyridylsulfamoyl)phenyl]azo]salicylic acid. Chemical Structure:

Sulfasalazine 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.

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NEWS HIGHLIGHTS

Published Studies Related to 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 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.

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 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.

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

Sulfasalazine review by 39 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		inflammatory arthritis
Dosage & duration:		1000 mg taken 2 x day for the period of still on it. Begin 4/2005.
Other conditions:		hyperthyroidism, tachycardia, high blood pressure, allergies
Other drugs taken:		predinisone, mobic, clairitin, singulair, allegra, attenolol, methimazole, tylenol,acidophilus
		Reported Results
Benefits:		lessening of pain, some increase in mobility - took abt 7 mos. to see improvement
Side effects:		diarrhea first couple of mos. until my body acclimated to the sulfasalazine.
Comments:		Took 2 tabs twice daily.

Sulfasalazine review by 54 year old male patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		Crohn's Disease
Dosage & duration:		500 mg taken 4 times daily, with food for the period of 6 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		None (see next entry).
Side effects:		Before I started using the drug I had none of the classic symptoms of Crohn's Disease (loose bowel movements, abdominal pain, etc.), but these side effects started when I started taking the drug, and subsided when I stopped. Also, I developed other side effects while using the drug, including low-level nausea, loss of appetite and headaches.
Comments:		I started off on a dose of 1 x 500 mg enteric-coated tabs four times daily (the doctor's recommended test dose to see if I responded negatively to the drug), but when I tried to increase this to 2x 500 mg tabs four times daily after one week, the side effects I had been experiencing increased, so I dropped back. I tried one more time to increase the dose more gradually (2 x 500 mg in the morning; then 1 x 500 mg at lunch, dinner and bedtime), but even this became too unpleasant to put up with (especially since I didn't have these symptoms before I started!). I perservered for 6 weeks, before deciding to taper the dose to zero over a couple of weeks, after which the symptoms disappeared.