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Study · Observational study · n = 200 · 2025

4 results

German Cohort Observational Study to Investigate the Short- and Long-Term Safety and Clinical Effectiveness of Afamelanotide 16 mg (SCENESSE) in Patients With Erythropoietic Protoporphyria (EPP).

Homey B, Schelonke K, Schlegel CM, Bruch-Gerharz D, Weller K, Kiefer L, Stölzel U, Staubach-Renz P, Wegner J, Keller-Melchior R, Walker G, Bochno M, Bilbao P

Photodermatology, photoimmunology & photomedicine1 Mar 2025Cited by 5 (Europe PMC)

PMID40082741 (opens in a new tab)PMCIDPMC11906902 (opens in a new tab)DOI10.1111/phpp.13012 (opens in a new tab)PepBankPUB-40082741
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanObservational studySafety outcome

    In German adults with erythropoietic protoporphyria, the real-world safety and benefit-risk profile of afamelanotide 16 mg was consistent with clinical trials.

    In plain wordsIn German adults with EPP, real-world safety of afamelanotide matched what clinical trials found.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableShort- and long-term safety profile
    Study

    n = 200

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The short- and long-term safety and benefit-risk profile of afamelanotide under real-world conditions is consistent with the positive safety profile seen in clinical trials.
    1 context sentence
    Summary · context
    Patients (n = 200, none untreated) received afamelanotide according to the summary of product characteristics.
  2. 02HumanObservational studyEfficacy outcome

    In German adults with erythropoietic protoporphyria, afamelanotide 16 mg was linked to a significant increase in quality of life versus baseline.

    In plain wordsIn German adults with EPP, quality of life was higher on afamelanotide than at baseline.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    IncreaseEPP-QoL change from baseline
    Study

    n = 200

    Comparator
    Baseline
    Outcome group
    Quality of life · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    EPP patients reported a significant increase in QoL compared with baseline values (p < 0.0001)
    1 context sentence
    Summary · context
    Patients (n = 200, none untreated) received afamelanotide according to the summary of product characteristics.
  3. 03HumanObservational studyEfficacy outcome

    In German adults with erythropoietic protoporphyria, 91.0% of patients who started afamelanotide 16 mg continued treatment.

    In plain wordsIn German adults with EPP, 91.0% of those who started afamelanotide kept taking it.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableTreatment continuity
    Study

    n = 200

    Outcome group
    Treatment adherence and retention · Skin and wound
    Studied dose
    Dose not stated

    Measurements

    Patients continuing treatment
    91%
    afamelanotide 16 mg

    Source sentences

    Summary
    91.0% of patients who started treatment continue being treated.
    1 context sentence
    Summary · context
    Patients (n = 200, none untreated) received afamelanotide according to the summary of product characteristics.
  4. 04HumanObservational studySafety outcome

    In German adults with erythropoietic protoporphyria aged over 70, the safety profile of afamelanotide was consistent with the overall patient population.

    In plain wordsIn German adults over 70 with EPP, afamelanotide safety matched that of all patients.

    Peptide
    Melanotan I (afamelanotide)
    Outcome
    Not applicableSafety in patients over 70 years
    Study

    n: not reported in source

    Comparator
    Overall patient population
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    The safety profile of afamelanotide in patients over 70 years of age is consistent with the overall patient population.
    1 context sentence
    Summary · context
    Patients (n = 200, none untreated) received afamelanotide according to the summary of product characteristics.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    13 Oct 2026, 21:44 UTC

    Study results updated

  2. Version 1

    13 Oct 2026, 16:31 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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