Women with moderately to severely active systemic lupus erythematosus treated with traditional agents experienced reduced disease activity after therapy with an adrenocorticotropic hormone gel, according to recent study results.
Justus J. Fiechtner, MD, MPH, and Tressa Montroy, Fiechtner Research in Lansing, Mich., conducted a single-site, open-label trial of 10 women with systemic lupus erythematosus (SLE; mean age, 49 years; disease duration, 7 years) between November 2012 and May 2013. Mean baseline Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score was 10, and patients were on adequate doses of conventional SLE treatment but exhibited exacerbated symptoms. Patients received 1 mL (80 U/mL) of adrenocorticotropic hormone (ACTH[1-39]) gel (H.P. Acthar Gel, Questcor Pharmaceuticals) by subcutaneous injection for 10 days with 5 additional days for part- or nonresponders (SLEDAI-2 K score >6). Patients were assessed weekly for 28 days.
Physician and patient global assessments, SLEDAI-2 K, Lupus Quality of Life (QOL) scale, Functional Assessment of Chronic Illness Therapy-Fatigue scale, erythrocyte sedimentation rate and C-reactive protein were outcome measures. Data at baseline were compared with that at 7, 14 and 28 days.
“The primary endpoint of SLEDAI-2 K improvement was reached at all observation times (P<.05) and statistically significant improvements were observed for most other parameters,” the researchers reported.
Lupus QOL at day 14 was the only change from baseline that was not significant, although significant improvement was noted at day 28. There were no reported treatment-related serious or unexpected adverse events.
“Acthar appears to be a viable treatment option for patients with SLE,” Fiechtnersaid in a press release. “Some patients on traditional lupus maintenance therapies can experience breakthrough disease activity, and our study has shown that Acthar may be an effective therapeutic alternative in such patients.”
“A larger, long-term examination of patient responses and side effects to treatment with ACTH(1-39) gel is warranted,” the researchers concluded.
Disclosure: The researchers received grant and research support from Questcor Pharmaceuticals.