Table of Contents

• Trial overview
• Rheumatoid arthritis studies
• Psoriatic arthritis study
• Crohn’s disease study
• Acute myeloid leukemia study
• What the outcomes mean for patients

Trial overview

The source data includes 7 clinical trials that study Sulfasalazine in different ways, either alone or as part of a treatment plan.^{[1][2][3][4][5][6][7]} These studies are in Phase 1, Phase 2, Phase 3, and one low-intervention design.^{[1][2][3][4][5][6][7]} The trials focus on people with inflammatory joint disease, bowel disease, and leukemia.^{[1][2][3][4][5][6][7]}

Rheumatoid arthritis studies

Several trials study rheumatoid arthritis, which is a long-term disease that causes joint pain, swelling, and stiffness.^[2][3][4][6] One Phase 3 study compares active conventional therapy with biologic treatments and also looks at two dose-reduction strategies in people who respond to treatment.^[3] Its main outcomes are remission at week 24, joint damage seen on x-ray scoring, and remission after the dose is reduced.^[3]

Another trial compares targeted therapies with triple therapy that includes Sulfasalazine, methotrexate or leflunomide, and hydroxychloroquine in patients who did not respond well enough to earlier treatment.^[2] The main goal is to see whether targeted therapy gives better low disease activity while keeping steroid use low.^[2] A Phase 2 proof-of-concept study also includes Sulfasalazine in a group of adults with active rheumatoid arthritis despite prior advanced therapies, and it measures change in DAS28-CRP at Week 12.^[4]

A newer Phase 3 study in rheumatoid arthritis compares a tailor-made treatment approach with routine care and uses patient features such as autoantibodies and response to glucocorticoids and JAK inhibitors to guide treatment choices.^[6] Its main outcomes include how many patients need biologic or targeted synthetic DMARDs after 10 months and how disease activity changes over time, plus cost-effectiveness measured by ICER.^[6]

Psoriatic arthritis study

One Phase 3 study looks at psoriatic arthritis, which is arthritis linked to psoriasis, a skin disease.^[5] The study tests how far immunosuppressive medication can be tapered without symptoms coming back in adults who already have stable minimal disease activity.^[5] The main outcomes are whether minimal disease activity is still present after 12 months and the PASDAS score at month 12.^[5]

Sulfasalazine is one of the medicines listed in the tapering study, which means it may be part of the treatment being reduced or adjusted.^[5] This kind of study helps researchers understand which patients can safely use less medicine while staying well controlled.^[5]

Crohn’s disease study

One Phase 3 pediatric study investigates Crohn’s disease, which is a type of inflammatory bowel disease that can cause belly pain, diarrhea, and poor growth in children.^[1] The study is in children with moderately to severely active disease and evaluates upadacitinib, while Sulfasalazine appears in the intervention list as a treatment used in the study setting.^[1]

The main outcomes are clinical remission by the Pediatric Crohn’s Disease Activity Index, endoscopic response, and the number of adverse events.^[1] The brief summary shows that the study is meant to compare remission and endoscopic response at Week 64 in a group of pediatric participants who first achieved clinical response at Week 12.^[1]

Acute myeloid leukemia study

One Phase 1 study examines acute myeloid leukemia, a fast-growing blood cancer, in older adults with newly diagnosed non-favorable disease.^[7] In this study, Sulfasalazine is added to chemotherapy with cytarabine and idarubicin to test the safety of the combination.^[7]

The Phase 1 part focuses on dose-limiting toxicity and finding the maximal tolerated dose, which is the highest dose that can be given with acceptable safety.^[7] The Phase 2 part looks at MRD-negative complete response at the end of induction, which means a complete response with no minimal residual disease detected by the study criteria.^[7]

What the outcomes mean for patients

Many of the trials use outcomes related to disease activity, which means how active the illness is at a given time.^{[2][3][4][5][6]} In rheumatoid arthritis, this may be measured by DAS28-CRP, CDAI, or DAS over time.^[2][3][4][6] In Crohn’s disease, researchers use PCDAI and endoscopy results, while in psoriatic arthritis they use MDA and PASDAS.^[1][5]

Safety is also important in these studies.^[1][7] Some trials count adverse events, and the leukemia study specifically tracks dose-limiting toxicity during dose escalation.^[1][7] Together, these trials show that researchers are studying whether Sulfasalazine can be part of effective treatment plans across several diseases and patient groups.^{[1][2][3][4][5][6][7]}