Table I.

Definitions for bullous pemphigoid

Early observation points
Baseline	Day that BP therapy is started by physician
Control of disease activity	Time at which new lesions cease to form and established lesions begin to heal or pruritic symptoms start to abate
Time to control of disease activity (disease control; beginning of consolidation phase)	Time interval from baseline to control of disease activity
End of consolidation phase	Time at which no new lesions have developed for minimum of 2 wk and approximately 80% of lesions have healed and pruritic symptoms are minimal
Intermediate observation end points
Transient lesions	New lesions that heal within 1 wk or pruritus lasting <1 wk and clearing without treatment
Nontransient lesions	New lesions that do not heal within 1 wk or pruritus continuing >1 wk with or without treatment
Complete remission during tapering	Absence of nontransient lesions while patient is receiving more than minimal therapy
Late observation end points
Minimal therapy	≤ 0.1 mg/kg/d Of prednisone (or equivalent) or 20 g/wk of clobetasol propionate and/or minimal adjuvant or maintenance therapy
Minimal adjuvant therapy and/or maintenance therapy	Following doses or less: methotrexate 5 mg/wk; azathioprine 0.7 mg/kg/d (with normal thiopurine s-methyltransferase level); mycophenolate mofetil 500 mg/d; mycophenolic acid 360 mg/d; or dapsone 50 mg/d
Partial remission on minimal therapy	Presence of transient new lesions that heal within 1 wk while patient is receiving minimal therapy for at least 2 mo
Complete remission on minimal therapy	Absence of new or established lesions or pruritus while patient is receiving minimal therapy for at least 2 mo
Partial remission off therapy	Presence of transient new lesions that heal within 1 wk without treatment while patient is off all BP therapy for at least 2 mo
Complete remission off therapy	Absence of new or established lesions or pruritus while patient is off all BP therapy for at least 2 mo
Mild new activity	<3 Lesions/mo (blisters, eczematous lesions, or urticarial plaques) that do not heal within 1 wk, or extension of established lesions or pruritus once/wk but less than daily in patient who has achieved disease control; these lesions have to heal within 2 wk
Relapse/flare	Appearance of ≥3 new lesions/mo (blisters, eczematous lesions, or urticarial plaques) or at least one large (>10 cm diameter) eczematous lesion or urticarial plaques that do not heal within 1 wk, or extension of established lesions or daily pruritus in patient who has achieved disease control
Failure of therapy for initial control	Development of new nontransient lesions or continued extension of old lesions, or failure of established lesions to begin to heal or continued pruritus despite:
	Clobetasol propionate 40 g/d for 4 wk; or
	Prednisone 0.75 mg/kg/d equivalent for minimum of 3 wk with or without drugs used for maintenance therapy; or
	A tetracycline on full dosing for 4 wk; or
	Dapsone 1.5 mg/kg/d for 4 wk; or
	Methotrexate 15 mg/wk (if >60 kg and no major renal impairment) for 4 wk; or
	Azathioprine 2.5 mg/kg/d for 4 wk (if thiopurine s-methyltransferase level is normal); or
	Mycophenolate mofetil 40 mg/kg/d (if normal renal function, otherwise according to age/creatinine clearance) for 4 wk

BP, Bullous pemphigoid.