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                • EMA 2004 — Guideline on clinical investigation of medicinal products for psoriasis (CHMP/EWP/2454/02)
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                • Mrowietz 2011 — European treat-to-target consensus for moderate-to-severe psoriasis
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  • Olsen 2004 — Alopecia areata investigational assessment guidelines (SALT definition, NAAF)

Olsen 2004 — Alopecia areata investigational assessment guidelines (SALT definition, NAAF)

Citation​

Olsen EA, Hordinsky MK, Price VH, Roberts JL, Shapiro J, Canfield D, et al. Alopecia areata investigational assessment guidelines — Part II. J Am Acad Dermatol. 2004 Sep;51(3):440–447. DOI: 10.1016/j.jaad.2003.09.032. PMID 15337988.

Study design and population​

National Alopecia Areata Foundation (NAAF) expert-consensus guideline. Defines the Severity of Alopecia Tool (SALT) — a continuous 0–100 score derived from four weighted scalp quadrants (13 %, 13 %, 24 %, 40 %–50 %). Companion to Part I.

Reported outcomes​

  • SALT-II (Olsen 2016, JAAD, DOI 10.1016/j.jaad.2016.08.042) adds finer resolution increments
  • SALT ≤ 20 and SALT-50 / 75 / 90 response thresholds subsequently adopted in regulatory trials (baricitinib, ritlecitinib, deuruxolitinib)
  • Consensus-derived instrument; no empirical reliability statistics in this publication

Surrogate-to-outcome linkage​

Consensus genesis of SALT as the regulator-accepted severity surrogate for alopecia areata. Downstream FDA / EMA approvals for JAK-inhibitor therapy use SALT response as the primary efficacy definition, anchoring it as a patient-relevant outcome proxy in the pivotal-trial literature.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Foundational — defines the SALT surrogate used in all subsequent AA trials.
CRIT2 Methodologyn/aConsensus guideline (expert panel).
CRIT3 Reporting2Instrument definition clear; no empirical psychometrics in this paper.
CRIT4 Applicability3Used verbatim in FDA / EMA-approved pivotal trials.
CRIT5 Evidence weight1Expert consensus document.
CRIT6 Risk of bias2Consensus without underlying reliability data at time of publication.
CRIT7 Contribution3Essential — without SALT definition, the baricitinib / ritlecitinib approvals have no surrogate.

Aggregate: strong (foundational).

Limitations and notes​

No empirical reliability statistics in the original paper; reliability data come from subsequent validations and from the regulatory approval dossiers.

Strength as anchor​

Strong as a foundational definition reference. Always paired with King 2022 (baricitinib BRAVE-AA) for the empirical response-to-therapy linkage.

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  • Citation
  • Study design and population
  • Reported outcomes
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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