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Beginning way back in 2005 the IPPF hosted an international scientific conference at the NIH (National Institutes of Health) which resulted in an agreement that it was important to develop consensus definitions for the disease of pemphigus. These definitions would be critical in supporting and evaluating clinical research. Following that meeting, the IPPF, through a directed fundraising campaign, delivered funds to sponsor and complete a pivotal study that developed such consensus definitions.

Over the course of several subsequent meetings of the premier experts in pemphigus, worldwide, the IPPFs support of the project results in the scientific/medical community now having a uniform and consistent consensus of definitions forremission”, “flares”, and other levels of disease activity. {quotes}Doctors and researchers can now uniformly agree on measurements of treatment efficacy in a consistent level, with comparable results, when reporting progress of trials or treaments.{/quotes} See the article, “Consensus Statement on Definitions of Disease Endpoints and Therapeutic Response for Pemphigusin the Journal of the American Academy of Dermatology, Issue 58 (June 2008), pages1043-6.

Werth and Murrell

The IPPF would very much like to recognize all the physicians who contributed to this process, including many of the experts that serve on the IPPF’s own Medical Advisory Board.Special mention goes to Dr. Victoria Werth, UPenn, PA (left in photo), and Prof. Dedee Murrell, Sydney, Australia (right) for spearheading these meetings and working diligently to make sure the process was always moving forward.

Early Observation Points

Baseline: The day that therapy is started by a physician.

Control of disease activity (disease control; beginning of consolidation phase): The time interval from baseline to the time at which new lesions cease to form and established lesions begin to heal.

End of the consolidation phase: The time at which no new lesions have developed for a minimum of 2 weeks, approx 80% of lesions have healed, and when most clinicians start to taper steroids.

Late Observation Endpoints

Complete remission off therapy: Absence of new or established lesions while the patient is off all systemic therapy for at least two months.

Complete remission on therapy: The absence of new or established lesions while the patient is receiving minimal therapy.

Other Definitions

Minimal therapy: Less than, or equal to, 10 mg/day of prednisone (or the equivalent) and/or minimal adjuvant therapy for at least two months.

Minimal adjuvant therapy: Half of the dose required to be defined as treatment failure.

Partial remission off therapy: Presence of transient new lesions that heal within one week without treatment and while the

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patient is off all systemic therapy for at least two months.

Partial remission on minimal therapy: The presence of transient new lesions that heal within one week while the patient is receiving minimal therapy, including topical steroids.

Relapse/Flare: Appearance of 3 or more new lesions a month that do not heal spontaneously within 1 week, or by the extension of established lesions, in a patient who has achieved disease control.

Failure of Therapy: Continued development of new lesions, continued extension of old lesions, or failure of established lesions to begin to heal despite 3 weeks of therapy on:

  • Prednisone: 1.5 mg/kg/d equivalent with or without any of the following agents:
    • Cyclophosphamide 2mg/kg/d for 12 weeks;
    • Azathioprine 2.5 mg/kg/d for 12 weeks (if thiopurine s-methyltransferase level is normal);
    • Methotrexate 20 mg/wk for 12 weeks; or Mycophenolate mofetil 3 g/d for 12 weeks.

* The methotrexate and mycophenolate mofetil are based on a 75 kg individual

Опубликовано в Issue 54 - Fall 2008

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