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Study · Non-randomized trial · n = 26 · 2015

3 results

Evaluation of the immunogenicity of the synthetic α-melanocyte-stimulating hormone (α-MSH) analogue afamelanotide ([Nle4-D-Phe7]-α-MSH, Scenesse®) in erythropoietic protoporphyria patients by ELISA detecting both anti-afamelanotide and anti-α-MSH antibodies.

Lengweiler S, Kreim S, Barman-Aksözen J, Maurer M, Minder EI

Skin pharmacology and physiology13 Nov 2014Cited by 8 (Europe PMC)

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study3

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In 26 patients with erythropoietic protoporphyria exposed to afamelanotide for up to 6 years, no immunoreactivity was found in 23.

    In plain wordsIn patients with erythropoietic protoporphyria treated with afamelanotide for up to 6 years, most showed no antibody reaction to the drug.

    Outcome
    No significant changeAnti-drug antibodies against afamelanotide
    Study

    n = 26

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated · up to 6 yearsAs given in this study (human).

    Measurements

    Patients without immunoreactivity
    23 patients
    EPP patients exposed up to 6 years

    Source sentences

    Summary
    No immunoreactivity was found in 23 of the 26 EPP patients exposed to the drug for up to 6 years.
  2. 02HumanNon-randomized trialSafety outcome

    In three patients with pre-existing immunoreactivity against afamelanotide and alpha-MSH, titres did not change during afamelanotide administration.

    In plain wordsIn three patients who already had antibodies before treatment, antibody levels did not change during afamelanotide treatment.

    Outcome
    No significant changeAntibody titre change during treatment in patients with pre-existing immunoreactivity
    Study

    n = 3

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Pre-existing immunoreactivity against afamelanotide as well as α-MSH was found in 3 patients, whose titres did not change during afamelanotide administration.

Studies that did not test the peptide alone1

In this study, Melanotan I (afamelanotide) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Melanotan I (afamelanotide).

  1. 03LabNot a test of Melanotan I (afamelanotide) aloneIn vitro (cell-free)Other

    A new ELISA detected specific antibodies against afamelanotide and alpha-MSH with sensitivities of 608 and 1,390 ng/ml.

    In plain wordsIn lab tests, a new ELISA detected antibodies against afamelanotide and alpha-MSH at stated sensitivity levels.

    Outcome
    Not applicableELISA sensitivity for antibodies against afamelanotide and alpha-MSH
    Study

    n: not reported in source

    ELISA
    Outcome group
    Immune response · Pharmacology

    Measurements

    Sensitivity
    608 ng/ml
    anti-afamelanotide ADA
    Sensitivity
    1390 ng/ml
    anti-alpha-MSH ADA

    Source sentences

    Summary
    The sensitivity of the ELISA was 608 and 1,390 ng/ml of specific ADA against afamelanotide and α-MSH, respectively.

    In this study, Melanotan I (afamelanotide) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Melanotan I (afamelanotide).

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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