ABSTRACT
Mycophenolate mofetil (MMF) is used off-label for systemic lupus erythematosus (SLE) and systemic vasculitis. The study aim was to investigate clinical use and treatment results with MMF in patients with SLE and systemic vasculitis. This study included patients with SLE or systemic vasculitis with ongoing or previous MMF treatment. Data on treatment outcome were obtained through medical record reviews. A total of 135 of 648 (21%) patients with SLE and 43 of 455 (9%) patients with systemic vasculitis had ongoing or previous MMF treatment. Among SLE patients, the most common organ manifestation at baseline (treatment start) was renal involvement (50%). Most of the systemic vasculitis patients had Wegener's granulomatosis (GPA) (65%). Median dose of MMF was 2000 mg/day. Glucocorticoid (GC) doses were significantly reduced during MMF treatment from 21.7 mg/day at baseline to 8.3 mg/day at 12 months (p < 0.05). Forty-six percent of the patients were good responders after 12 months. The most common adverse events (AES) leading to discontinuation were side effects in the gastrointestinal tract (40%) and general side effects (30%). "Survival-on-drug" analysis suggested that 40% of the patients remained on long-term MMF treatment. In conclusion, MMF was used in 21% of the SLE patients and 9% of the systemic vasculitis patients. MMF appeared to be effective with a reasonable survival-on-drug and a GC-sparing effect.
Subject(s)
Academic Medical Centers , Immunosuppressive Agents/therapeutic use , Lupus Erythematosus, Systemic/drug therapy , Mycophenolic Acid/analogs & derivatives , Systemic Vasculitis/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , Child , Drug Therapy, Combination , Female , Glucocorticoids/therapeutic use , Humans , Immunosuppressive Agents/adverse effects , Kaplan-Meier Estimate , Lupus Erythematosus, Systemic/diagnosis , Lupus Erythematosus, Systemic/immunology , Male , Middle Aged , Mycophenolic Acid/adverse effects , Mycophenolic Acid/therapeutic use , Retrospective Studies , Sweden , Systemic Vasculitis/diagnosis , Systemic Vasculitis/immunology , Time Factors , Treatment Outcome , Young AdultABSTRACT
The objective of this paper is to investigate drivers of cost and health-related quality of life (HRQoL) related to disease activity and fatigue among patients with systemic lupus erythematous (SLE). A questionnaire was sent to members of a patient organization with a self-reported diagnosis of SLE, requesting information on demographics and disease characteristics, medications, resource utilization, informal care, loss of productivity, fatigue and HRQoL in relation to SLE. Mean annual costs per patient were estimated from a societal perspective. HRQoL was measured through EQ-5D and fatigue was measured through a 10 cm VAS scale. Patient-reported disease activity was measured through the Systemic Lupus Activity Questionnaire (SLAQ) and corticosteroid dose. Drivers of costs and HRQoL were analyzed through regression analysis. A total of 339 patients out of 737 returned the questionnaire. Mean age was 55; 94% were female. The mean HRQoL measured through the five-item EQ-5D instrument was 0.64 and total costs were estimated at 22,594 (direct costs 7818; indirect costs 14,776). Disease activity, fatigue and corticosteroid doses had a statistically significant impact on costs and HRQoL. This study demonstrates that Swedish patients with SLE have low HRQoL and incur high societal costs and that are both associated with and most likely driven by disease activity, fatigue and corticosteroid use.
