Autor: |
Namas, Rajaie, Tashkin, Donald P., Furst, Daniel E., Wilhalme, Holly, Tseng, Chi‐Hong, Roth, Michael D., Kafaja, Suzanne, Volkmann, Elizabeth, Clements, Philip J., Khanna, Dinesh, Elashoff, R., Goldin, J., Roth, M., Furst, D., Bulpitt, K., Chung, W.‐L. J., Viasco, S., Sterz, M., Woolcock, L., Yan, X., Ho, J., Vasunilashorn, S., Costa, I., Seibold, J. R., Riley, D. J., Amorosa, J. K., Hsu, V. M., McCloskey, D. A., Wilson, J. E., Varga, J., Schraufnagel, D., Wilbur, A., Lapota, D., Arami, S., Cole‐Saffold, P., Simms, R., Theodore, A., Clarke, P., Korn, J., Tobin, K., Nuite, M., Silver, R., Bolster, M., Strange, C., Schabel, S., Smith, E., Arnold, J., Caldwell, K., Bonner, M., Wise, R., Wigley, F., White, B., Hummers, L., Bohlman, M., Polito, A., Leatherman, G., Forbes, E., Daniel, M., Martin, D., Steen, V., Read, C., Cooper, C., Wheaton, S., Carey, A., Ortiz, A., Mayes, M., Parsley, E., Oldham, S., Filemon, T., Jordan, S., Perry, M., Connolly, K., Golden, J., Wolters, P., Webb, R., Davis, J., Antolos, C., Maynetto, C., Fessler, B., Olman, M., Sanders, C., Heck, L., Parkhill, T., Rothfield, N., Metersky, M., Cobb, R., Aberles, M., Ingenito, F., Breen, E., Mayes, M., Mubarak, K., Granda, J. L., Silva, J., Injic, Z., Alexander, R., Furst, D., Springmeyer, S., Kirkland, S., Molitor, J., Hinke, R., Mondt, A., Thompson, T., Rounds, S., Weinstein, M., Thompson, B., Paulus, H., Levy, S., Kissin, E., Cheong, F.Y., Marlis, G., Mason‐Berry, J., Saffold, P., Rodriguez, M., Guzman, L., Brook, J., Ibrahim, G., Largaespada, K., Fridley, C., Zulmastashvili, M., Manu, A., Moore, S., Hummers, L., Leatherman, G., Hant, F. N., Gibson, K., Morrison, M., Donnelly, H., Marlin, C., Gangar, J., McCloskey, D. A., Eller, A., Leong, D., Lalosh, M., Obata, J., Arami, S., Franklin, D., Schiopu, E., Benedict‐Blue, M., Leone, V., Shaw, J., Tan, F., Perry, M., Anderson, J., Saulino, A., Carey, P., Esplin, M., Carlson, P. |
Zdroj: |
Arthritis Care and Research; March 2018, Vol. 70 Issue: 3 p439-444, 6p |
Abstrakt: |
To assess the efficacy of mycophenolate mofetil (MMF) and cyclophosphamide (CYC) on modified Rodnan skin score (MRSS) in participants enrolled in the Scleroderma Lung Study (SLS) I and II. SLSI participants received daily oral CYCor matching placebo for 1 year, whereas SLS IIparticipants received daily MMFfor 2 years or daily oral CYCfor 1 year followed by placebo for second year. We assessed the impact of MMFand CYCon the MRSSin SLS IIover a 24‐month period. We also compared the change in MRSSin patients with diffuse cutaneous systemic sclerosis (dcSSc) assigned to CYCand MMFin SLS IIand SLSI versus placebo in SLSI over a 24‐month period using a linear mixed model. In SLS II, the baseline mean ± SD MRSSwas 14.0 ± 10.6 units for CYCand 15.3 ± 10.4 units for MMF; 58.5% were classified as dcSSc. CYCand MMFwere associated with statistically significant improvements in MRSSfrom baseline over the period of 24 months in dcSSc (P< 0.05 at each time point), but there were no differences between the 2 groups. In the dcSSc subgroup, the change in MRSSfrom baseline to all 6‐month visits was similar in SLS IIgroups (MMF,CYC, pooled cohort [MMF+ CYC]) and in the SLSI CYCgroup and showed statistically significant improvements compared to SLSI placebo at 12, 18, and 24 months (P< 0.05). In SLS II,MMFand CYCtreatment resulted in improvements in MRSSin patients with dcSSc over 24 months. In addition, MMFand CYCtreatment resulted in statistically significant improvements in MRSSin patients with dcSSc when compared with the SLSI placebo group. |
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