Faculty Collaboration Database

Minocycline is not effective in systemic sclerosis: results of an open-label multicenter trial. Arthritis Rheum 2004 Feb;50(2):553-7

Date

02/12/2004

Pubmed ID

14872498

DOI

10.1002/art.20036

Scopus ID

2-s2.0-1042290310 (requires institutional sign-in at Scopus site)   28 Citations

Abstract

OBJECTIVE: To determine if minocycline therapy improved skin thickness in early, diffuse systemic sclerosis (SSc) by > or =30%, a level of improvement unlikely to occur in the natural history of the disease as determined by recent controlled trials.

METHODS: Subjects with diffuse SSc of < or =5 years' duration were treated with oral minocycline for 1 year. The primary outcome measure was the modified Rodnan skin thickness score (MRSS).

RESULTS: Of 36 subjects initially enrolled, 31 returned for at least 1 followup visit and were included in the analysis (modified intent-to-treat analysis). The group consisted of 23 women and 8 men, with a mean age of 51.7 years (range 26-82 years) and a mean disease duration of 23.5 months (range 6-60 months). The mean MRSS at entry was 22.7 (range 12-43), and at the final visit it was 18.6 (range 2-48). There was no statistically significant difference in the change in skin scores between the minocycline-treated subjects and subjects previously reported in the D-penicillamine (D-Pen) trial. In addition, when adjusted for disease duration, a comparison of MRSS in the minocycline trial subjects (including all subjects active at each time point) and the previously reported D-Pen trial subjects showed no difference and no treatment effect. Fourteen subjects did not complete all 12 months of treatment; 10 of them withdrew due to disease progression. Disease duration was significantly shorter for the noncompleters than for the completers (P < 0.03).

CONCLUSION: The degree of change in the MRSS was similar to that expected in the natural course of this disease. Based on these data, minocycline is not an effective therapy for SSc.

Author List

Mayes MD, O'Donnell D, Rothfield NF, Csuka ME

Author

Mary Ellen Csuka MD Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Administration, Oral
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents
Dose-Response Relationship, Drug
Female
Humans
Male
Middle Aged
Minocycline
Penicillamine
Scleroderma, Systemic
Severity of Illness Index
Skin
Treatment Outcome