Objective. To test the safety and efficacy of olsalazine in men with a
nkylosing spondylitis (AS) unresponsive to nonsteroidal antiinflammato
ry drugs and physiotherapy. Methods. Four patients, including 2 who ha
d not responded to sulfasalazine (SASP) and one who did not tolerate S
ASP, were treated with olsalazine, up to 3 g/dl for 24 weeks. Results.
One patient discontinued olsalazine due to diarrhea at 1 g/day. The o
ther 3 experienced improvement in global spine self assessment by visu
al analog scale (VAS), 2 of 3 patients, spinal pain (VAS, 3 of 3), nig
ht pain (3 of 3), tender joint count (3 of 3) and enthesis score (3 of
3). Changes in Schober's test and chest expansion were minor. Erythro
cyte sedimentation rate and C-reactive protein were normal. Loose stoo
ls were the only adverse effects observed. Conclusion. Olsalazine appe
ars to be well tolerated and effective in men with AS, Further study o
f olsalazine and direct comparison with SASP in this population may il
luminate mechanisms of drug action and add a new therapeutic option.