Ultraviolet-A1 (UV-A1) wavelengths have been found effective in mitiga
ting signs and symptoms of disease activity in systemic lupus erythema
tosus (SLE) but studies have been uncontrolled. To rigorously assess t
he effectiveness and safety of daily low-dose UV-A1 irradiation as a t
herapeutic agent in this disorder we enrolled 26 women with SLE in an
18-week two-phase-study. During the initial six-week prospective, doub
le-blind, placebo-controlled phase, the patients were divided into two
groups; Group A was exposed to 60 kJ/m(2) of UV-A1 (340-400 nm) irrad
iation within a sunbed five days a week for three weeks and Group B wa
s exposed for an equal amount of time to visible light of greater than
>430 nm (placebo). Each group was then crossed over for exposure to t
he other source for three weeks. During the second phase - 12 weeks -
patients and physicians were unblinded and patients were irradiated wi
th progressively decreasing levels of UV-A1 only. Twenty-five patients
completed the six-week placebo-controlled phase of the study and eigh
teen patients participated for the entire 18 weeks. In Group A the sys
temic lupus activity measure (SLAM) score improved significantly after
three weeks of five-day-a-week UV-A1 irradiation (P < 0.05), regressi
ng to baseline during the three weeks of placebo irradiation. Improvem
ent recurred and progressed with six weeks of three-day-a-week UV-A1 i
rradiation (P < 0.05). Group B patients responded negligibly to the th
ree weeks of visible light, more sharply to UV-A1, and as with Group A
, maximally to the six weeks of three-day-a-week UV-A1 (P < 0.01). Wit
h twice- and then once-weekly UV-A1 irradiation the SLAM scores worsen
ed slightly. All patients decreased their drug use. Anti-double-strand
ed DNA antibodies (anti-dsDNA) decreased significantly (P < 0.05) and
anti-nuclear antibodies non-significantly. Side effects were negligibl
e. Visible light had no significant effect. In conclusion, low-dose UV
-A1 irradiation effectively, comfortably, and without apparent toxicit
y diminished signs and symptoms of disease activity in SLE.