After five years of treatment, lupus patients enrolled in a non-standard cyclophosphamide(Drug information on cyclophosphamide)/rituximab regimen at the Hospital for Special Surgery (HSS) in New York have shown dramatic and sustained improvement in prednisone(Drug information on prednisone) dosage as well as in numerous markers of disease status, Thomas Lehman MD reported today at the American College of Rheumatology (ACR) meeting. Often these people will ask whether they still have lupus, he said, and why they need to keep taking prednisone.
The regimen dramatically reduces the number of cycles of cyclophosphamide treatments, from about 17 to merely 4, in exchange for the theoretical added risks of concomitant rituximab(Drug information on rituximab) exposure. The New York team gives rituximab at 750 mg/m2 on day one, an equivalent dose of cyclophosphamide on day 2, and repeats the same regimen on days 15-16 and a further two doses of each drug again six and 18 months after baseline. Treatments are given without regard to measured CD19 level.
Prednisone doses are gradually decreased at the discretion of the treating physician.
Five years after initiation of this regimen, the team reports significant improvements in prednisone dosage as well as in C4, Hb, ESR, Cr, and serum albumin. SLEDA1 scores diminished from 8.9 to 1.9 after just six months of treatment, and remained low. No patients have experienced a serious disease flare in that time, and four were known to be ANA negative at 36 months.
The study reported at the ACR meeting involved only 15 patients, but Lehman says another 25 patients treated subsequently are experiencing similar results.
Rheumatologists observing the presentation expressed concern about the risk of immunosuppression and infection, particularly in a disease common to young women, in light of the thought-provoking results of trials such as LUNAR and EXPLORER.
“Although we had no significant problems, there is always a risk of infection or malignancy in patients who are immunosuppressed,” Lehman responded. “However, the infection and other risks associated with chronic moderate- or high-dose corticosteroids is well known and is avoided by this therapy. Our patients seem to have done better, but larger studies will be necessary to provide conclusive answers.”
("Cure?" he wrote earlier in a publication intended for parents and patients. "It's too soon to say.")
Also from ACR2012:
“Magic Bullet” Approaching for Systemic JIA: But Which One?
FDA Panel on Biosimilars: Analytics Should Trump Clinical Trials
JAK Inhibitors Newer Than Tofacitinib (and Better?) Wait in the Wings
Rheumatic Drug Safety Updates 2012: FDA at the ACR Meeting
Sex and Other Risks: Caring for Teens in Pediatric Rheumatology