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Definitions of commonly-used terminology used by the US National Psoriasis Foundation (NPF), the European Medicines Agency (EMEA) and this study. |
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| Term |
NPF [20] |
EMEA [21] |
This study |
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| During treatment |
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| Flare |
Typical or unusual worsening of disease during treatment and/or the occurrence of new psoriasis morphologies. |
Not defined. |
Not used |
| Following treatment discontinuation |
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| Recurrence |
Not defined |
The EMEA recommend the use of recurrence as an endpoint in long-terms studies provided that it is clearly defined. |
The term 'inflammatory recurrence' includes (a) patients with worsening of psoriasis within 2 months of discontinuation from efalizumab treatment to a level less severe than a rebound and (2) patients who have discontinued a psoriasis treatment due to an inflammatory disease flare but, following discontinuation, require treatment to prevent a rebound. |
| Relapse |
Loss of 50% of PASI improvement from baseline in patients who achieve a clinically meaningful response (≥ 50% improvement in PASI score from baseline). |
A reduction of >50% in PASI from the achieved maximal improvement in PASI score. Subjective alternative: a relapse of psoriasis necessitating the re-initiation of treatment. A simple worsening of psoriasis beyond 2 months of therapy may represent the natural course of the disease (relapse) rather than a rebound associated with drug. |
Not used |
| Rebound |
A PASI of 125% of baseline or new generalized pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping therapy. Worsening occurring after 3 months of therapy may represent the natural course of the disease rather than a rebound associated with the drug. |
Worsening of psoriasis over baseline value (e.g. PASI>125%) or new pustular, erythrodermic or more inflammatory psoriasis occurring within 2 months of stopping therapy. A 2-month boundary separating relapse and rebound is drawn on theoretical grounds and is more or less arbitrary. |
Not used |
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PASI, Psoriasis Area and Severity Index | |||
Papp et al. BMC Dermatology 2006 6:9 doi:10.1186/1471-5945-6-9 |
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