Objective, Sulfasalazine (SSZ) has been found to have beneficial effects in
the treatment of patients with spondyloarthropathy (SpA) with active disea
se, The effectiveness of SSZ is limited by both idiosyncratic and dose rela
ted side effects when treating SpA. Mesalamine is a drug used to treat infl
ammatory bowel disease. Case reports have suggested potential efficacy in S
pA. We investigated the efficacy and safety of the Pentasa(R) formulation o
f mesalamine in treating SpA.
Methods. Thirty patients with SpA as defined by the European Spondylarthrop
athy Study Group were recruited from a rheumatology specialty clinic. All s
ubjects began 16 week open label therapy with mesalamine 1500 mg/day. Dose
escalation for lack of efficacy was permitted after 8 weeks of therapy, Cli
nical, physical, and laboratory data were collected at baseline, at 8 weeks
, and at the conclusion of the study at 16 weeks.
Results, Twenty-nine of the 30 patients completed the study. There was clin
ically and statistically significant improvement in all clinical measures (
morning stiffness, night awakenings, quality of sleep, severity of stiffnes
s, severity of pain, Dougados functional index, patient and physician globa
l indices), Joint counts and enthesitis counts improved, but measures of ax
ial flexibility did not. Erythrocyte sedimentation rate and C-reactive prot
ein also improved over the duration of the study.
Conclusion, In this population of patients with SpA, mesalamine was well to
lerated in the dose range 1500 to 4000 mg/day. Improvements in clinical, ph
ysical, and laboratory measures indicate the efficacy of mesalamine in trea
ting SpA.