Relapses occurred in 12 patients (71%) at a mean time of 10??1.8 months after BCDT. A second cycle of BCDT achieved a more sustained remission in seven of nine patients (78%) lasting for any mean time of 18.4??2.7 months. Minor adverse events were experienced by three patients. Mean follow-up was 30 months. Our own results and the literature review demonstrate that BCDT based on rituximab is usually well tolerated and may be effective for cutaneous lesions of lupus erythematosus. Randomized controlled trials are necessary to further evaluate the value of BCDT for this group of patients. test. values of 0.05 were considered to be statistically significant. Results Efficacy and security of BCDT in our patients In this study, one man and 16 women of different ethnicities (seven Whites, eight Afro-Caribbeans and two Asians) were included. The mean age was 43??3.6 years, and the mean disease duration prior to BCDT was 11??1.8 years. All patients were refractory to previous treatments including oral prednisolone and antimalarials, topical steroids and/or topical tacrolimus for at least six months with the exception of individual 16, who did not tolerate antimalarials. In addition, 12/17 patients (71%) experienced received classical immunosuppressive brokers without improvement. B-cell depletion defined as CD19 absolute figures 0.005??109/l was achieved by all patients following BCDT. Mean time to B-cell repopulation was 7.7??1.2 months (range three to 18 months). Although 12 patients (71%) demonstrated a fast improvement of at least 50% of their skin lesions within three months after the Polidocanol first BCDT treatment, it was, however, only of short period in some patients. Two patients (no. 8 and 11) exhibited a slower response, with CR or PR occurring four and five months after BCDT, respectively. Six months after the first BCDT, CR was observed in five of 17 patients (29.4%) and PR in four of 17 patients (23.5%). Eight patients experienced SD (47.1%). These results are shown as changes in the mucocutaneous BILAG score in Physique 1 (a) for the SLE patients. Of the three patients without SLE and therefore lacking BILAG assessment (patients no. 15C17), both patients with SCLE achieved PR while the individual with DLE and rheumatoid arthritis remained active (SD). Open in a separate window Physique 1 Clinical response to BCDT treatment in lupus erythematosus patients with severe cutaneous manifestations treated at UCLH. (a) Bars represent the mucocutaneous BILAG score at zero, three and six months after BCDT in 14 SLE patients. Numbers around the x-axis refer to the patients as explained in Table 1. BILAG A indicates a severe mucocutaneous involvement, BILAG B moderate, BILAG C moderate and BILAG D inactive mucocutaneous disease. (b) BILAG scores of Polidocanol eight SLE patients who relapsed and received a second cycle of BCDT (mucocutaneous score at zero, three and six months after BCDT). With regard to the subtype of cutaneous lesions, two of three ACLE patients (66.6%), two of three SCLE patients (66.6%) and two of three SLE patients with Polidocanol non-specific lesions (66.6%) were in CR or PR six months after the first cycle of BCDT, in contrast to only three of eight Rabbit Polyclonal to PE2R4 (37.5%) patients with CCLE lesions. We have not observed any transition from one type of cutaneous manifestation to another type following BCDT. Eight of 17 (47%) patients had elevated dsDNA antibodies prior to BCDT (mean 476.9??220.6?IU/ml). There was a pattern to a reduction of dsDNA levels within six months to 242.8?IU/ml??138.9 which did not reach statistical significance ( em p /em ?=?0.38). CR or PR was obtained by six of eight (75%) patients with anti-dsDNA antibodies compared to five of nine (56%) of anti-dsDNA unfavorable patients. Low match C3 was detectable in 10/17 (59%) patients (mean 0.71?g/l??0.05) before treatment, but improved significantly (mean 0.95?g/l??0.04) after six months ( em p /em ?=?0.001). Adverse events were experienced by two patients (urticaria post-infusion or recurrent chest infections after BCDT), but no severe complications occurred. Although six patients (35%) managed PR or CR for more than 12 months (patients no. 3 and 7 with ACLE, patient no. 15 with.