Sulfasalazine is an anti-inflammatory drug structurally related to salicylates and other non-steroidal anti-inflammatory drugs. It is indicated for managing inflammatory diseases such as ulcerative colitis and rheumatoid arthritis (RA). Metabolized by intestinal bacteria, sulfasalazine is broken down into mesalazine and sulfapyridine, 2 compounds that carry out the main pharmacological activity of sulfasalazine.
Sulfasalazine was first used in 1940 for rheumatic polyarthritis, and has been firmly established itself as one fo the most useful disease-modifying antirheumatic drug (DMARD). Compared to the first line treatment of RA like methotrexate, sulfasalazine is almost as efficacious as methotrexate although with slightly less tolerability. However, sulfasalazine has less teratogenic side effects and faster onset of action compared to conventional DMARD. Sulfasalazine fell out of favor as the drug of choice for RA due to poorly designed clinical trials in 1950 but regained interest from the clinical community in the late 1970.
Although sulfasalazine is only approved by the FDA for ulcerative colitis, research have shown that sulfasalazine is also beneficial for patients with Crohn's disease. Meta-analysis of 19 randomized controlled trials indicated that sulfasalazine is superior to placebo in inducing remission; however, with no supported evidence of mucosal healing, sulfasalazine is not FDA-recommmended for treatment of Crohn's disease.
In the US, sulfasalazine is indicated to treat mild to moderate ulcerative colitis and to prolong the remission period between acute attacks of ulcerative colitis. Sulfasalazine is also indicated as an adjunct therapy in severe ulcerative colitis.For the delayed-release tablet formulation, sulfasalazine is also indicated to treat rheumatoid arthritis in pediatric patients who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs or polyarticular-course juvenile rheumatoid arthritis with the same patients' characteristics.
Chung Shan Medical University Hospital, Taichung, Taiwan
Outpatient Care Center, Chicago, Illinois, United States
Parexel Early Phase Unit, Baltimor, Maryland, United States
Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital, Leeds, West Yorkshire, United Kingdom
IRIS Research and Development, Plantation, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Investigational Site Number 392039, Fukuoka-Shi, Japan
Investigational Site Number 392006, Sasebo-Shi, Japan
Investigational Site Number 392023, Takaoka-Shi, Japan
Investigational Site Number 152050, Santiago, Chile
Investigational Site Number 152007, Viña Del Mar, Chile
Investigational Site Number 484005, Monterrey, Mexico
Laiko General Hospital; Dept. of Pathophysiology-Uni of Athens, Athens, Greece
Uni Hospital of Ioannina; Rheumatology, Ioannina, Greece
General Hospital of Thessaloniki HIPPOKRATIO; Clinical Immunology Unit,2nd Dept of Internal Medicine, Thessaloniki, Greece
Investigational Site Number 840033, Fort Lauderdale, Florida, United States
Investigational Site Number 840150, Lansing, Michigan, United States
Investigational Site Number 840022, Dallas, Texas, United States
Investigational Site Number 840018, Idaho Falls, Idaho, United States
Investigational Site Number 840058, Columbia, South Carolina, United States
Investigational Site Number 840124, Clarksburg, West Virginia, United States
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