One-year open-label trial of thalidomide in ankylosing spondylitis.
OBJECTIVE
To test in a large open study whether thalidomide is potentially useful in treating ankylosing spondylitis, and to see if thalidomide induces any change in expression of genes in peripheral blood mononuclear cells (PBMC).


METHODS
Thirty male patients with treatment-refractory ankylosing spondylitis were recruited into a 12-month open study using thalidomide at a dosage of 200 mg/day. Seven indices were measured as primary outcome measures, and 6 other indices as secondary outcome measures. Transcripts in the PBMC of some of these patients were first screened with microarray, and then measured with reverse transcriptase-polymerase chain reaction.


RESULTS
Twenty-six patients completed the study. Of these, 80% showed a >20% improvement in 4 of 7 primary indices. Sharp declines in several parameters were noticed at 3-6 months. Nine patients became pain-free. There was also a statistically significant decrease in tumor necrosis factor alpha transcripts in the PBMC.


CONCLUSIONS
Thalidomide is a reasonably promising drug in treatment-resistant ankylosing spondylitis.
Chinese PLA General Hospital, Beijing, China.
Feng
F
Huang
Jieruo
J
Gu
Wei
W
Zhao
Jian
J
Zhu
Jianglin
J
Zhang
David Tak Yan
DT
Yu
D000328:Adult; D015870:Gene Expression / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007963:Leukocytes, Mononuclear / Q000502:physiology; D008297:Male; D008875:Middle Aged; D020411:Oligonucleotide Array Sequence Analysis; D013167:Spondylitis, Ankylosing / Q000188:drug therapy* / Q000235:genetics; D013792:Thalidomide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000235:genetics
D007166:Immunosuppressive Agents; D014409:Tumor Necrosis Factor-alpha; D013792:Thalidomide