Treatment of polyarteritis nodosa and microscopic polyangiitis with poor prognosis factors: a prospective trial comparing glucocorticoids and six or twelve cyclophosphamide pulses in sixty-five patients.

Abstract

OBJECTIVE:

Because the optimal cyclophosphamide (CY) treatment duration for severe polyarteritis nodosa (PAN) without virus infection and microscopic polyangiitis (MPA) has not been established, we conducted a trial to compare the effectiveness of 6 versus 12 CY pulses given in combination with corticosteroids (CS).

METHODS:

Sixty-five (18 PAN, 47 MPA) previously untreated patients were randomized to receive 12 (n = 34) or 6 (n = 31) CY pulses combined with CS. PAN and MPA were histologically proven or met ACR criteria. All patients presented >or=1 factor of severity according to the five factor score (FFS). CY pulses were administered every 2 weeks for 1 month, then every 4 weeks. The end point of the study was the number of events (relapses and/or deaths) occurring in each group, analyzed according to an intention-to-treat strategy. The outcome was evaluated by Cox proportional hazards analysis.

RESULTS:

The baseline characteristics were similar for both groups. The mean (+/- SD) followup was 32 +/- 21 months. Survival analysis showed a significantly lower relapse probability (P = 0.02; hazards ratio [HR] = 0.34) and higher event-free survival (P = 0.02, HR = 0.44) for the 12 CY-pulse group while the mortality rates were not significantly different (P = 0.47).

CONCLUSION:

These results suggest that 6 CY pulses are less effective than 12 CY pulses to treat severe PAN and MPA, particularly with respect to the risk of relapses.

• Authors: Loïc Guillevin, Pascal Cohen, Alfred Mahr, Jean-Pierre Arène, Luc Mouthon, Xavier Puéchal, Edouard Pertuiset, Brigitte Gilson, Mohamed Hamidou, Patricia Lanoux, Alain Bruet, Marc Ruivard, Philippe Vanhille, Jean-François Cordier
• Journal: Arthritis and rheumatism (Arthritis Rheum) Vol. 49 Issue 1 Pg. 93-100 (Feb 15 2003) ISSN: 0004-3591 [Print] United States
• PMID: 12579599 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Glucocorticoids
• Cyclophosphamide

Topics

• Adult
• Aged
• Antirheumatic Agents (administration & dosage, adverse effects)
• Cyclophosphamide (administration & dosage, adverse effects)
• Female
• Follow-Up Studies
• Glucocorticoids (administration & dosage, adverse effects)
• Humans
• Male
• Microcirculation
• Middle Aged
• Polyarteritis Nodosa (drug therapy, mortality)
• Prognosis
• Prospective Studies
• Pulse Therapy, Drug
• Survival Analysis
• Treatment Outcome