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Clinical subgroupings of ANCA-associated systemic vasculitis with predominant small vessel involvement, randomised trial names, and basic and alternative treatment regimens for the ECSYSVASTRIAL and AVERT projects. (WG: Wegener’s granulomatosis; MPA: microscopic polyangiitis; RLV: renal-limited vasculitis; Cr: serum creatinine in mmol/l; OCS: oral corticosteroids; CYC: cyclophosphamide; MTX: methotrexate; AZA: azathioprine; ATG: anti-thymocyte-immunoglobulin; ST: sulfamethoxazole-trimethoprim)
| Clinical subgroup and trial name | Diseases | Organ involvement | Treatment |
ECSYSVASTRIAL
| early systemic NORAM | WG, MPA | any, except renal or imminent vital organ failure | OCS and either oral CYC or oral, weekly MTX |
| generalised CYCAZAREM | WG, MPA, RLV | renal with Cr < 500 and/or imminent vital organ failure | OCS and CYC for 3 months, then either continued oral CYC or switch to AZA |
| severe renal MEPEX | WG, MPA, RLV | renal with Cr > 500 | OCS and CYC and either I.V. methyl prednisolone or plasma exchange |
| refractory SOLUTION | WG, MPA | frequently relapsing or progressive, life-threatening, standard treatment of no use | ATG daily for 10 subsequent days. Methyl prednisolone and AZA as necessary adjuvants |
AVERT
|
early systemic
or generalised
IVISTAT (CANCELLED) |
WG, MPA, RLV | Cr < 150 New disease | OCS and CYC + switch to AZA and either 8 courses of IVIg or 24 months of ST or both |
| generalised or severe renal CYCLOPS | WG, MPA, RLV | CR > 150 New disease | OCS and CYC + switch to AZA with either continuous oral CYC or intermittant pulse oral CYC |
| early systemic or generalised MUPIBAC | WG | GFR > 50 ml/min and in remission after 18 months from start of ECSYSVASTRIAL clinical trial | either no treatment or mupirocin nasal ointment one week a month |
| generalised or severe renal REMAIN | WG, MPA, RLV | GFR < 50 ml/min for WG only and in remission after 18 months from start of ECSYSVASTRIAL clinical trial | either withdraw OCS and AZA between 18 and 24 months or continue low dose OCS and AZA until 48 months |