Phase 2 Trial of Iberdomide in Systemic Lupus Erythematosus.

Adaptor Proteins, Signal Transducing / agonists Adult Dose-Response Relationship, Drug Double-Blind Method Female Humans Ikaros Transcription Factor / metabolism Lupus Erythematosus, Systemic / drug therapy Male Middle Aged Morpholines / administration & dosage Phthalimides / administration & dosage Piperidones / administration & dosage Severity of Illness Index Ubiquitin-Protein Ligases / metabolism

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
17 03 2022
Historique:
entrez: 16 3 2022
pubmed: 17 3 2022
medline: 25 3 2022
Statut: ppublish

Résumé

Iberdomide, a cereblon modulator promoting degradation of the transcription factors Ikaros and Aiolos, which affect leukocyte development and autoimmunity, is being evaluated for the treatment of systemic lupus erythematosus (SLE). In this phase 2 trial, we randomly assigned patients in a 2:2:1:2 ratio to receive oral iberdomide (at a dose of 0.45, 0.30, or 0.15 mg) or placebo once daily for 24 weeks, in addition to standard medications. The primary end point at week 24 was a response on the SLE Responder Index (SRI-4), which was defined as a reduction of at least 4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 score (a 24-item weighted score of lupus activity that ranges from 0 to 105, with higher scores indicating greater disease activity), no new disease activity as measured on the British Isles Lupus Assessment Group 2004 index, and no increase of 0.3 points or more in the Physician's Global Assessment score (on a visual-analogue scale ranging from 0 [no disease activity] to 3 [maximal disease]). A total of 288 patients received the assigned intervention: 81 received iberdomide at a dose of 0.45 mg, 82 received iberdomide at a dose of 0.30 mg, 42 received iberdomide at a dose of 0.15 mg, and 83 received placebo. At week 24, the percentages of patients with an SRI-4 response were 54% in the iberdomide 0.45-mg group, 40% in the iberdomide 0.30-mg group, 48% in the iberdomide 0.15-mg group, and 35% in the placebo group (adjusted difference between the iberdomide 0.45-mg group and the placebo group, 19.4 percentage points; 95% confidence interval, 4.1 to 33.4; P = 0.01), with no significant differences between the groups that received the lower doses of iberdomide and the group that received placebo. Iberdomide-associated adverse events included urinary tract and upper respiratory tract infections and neutropenia. In this 24-week, phase 2 trial involving patients with SLE, iberdomide at a dose of 0.45 mg resulted in a higher percentage of patients with an SRI-4 response than did placebo. Data from larger, longer trials are needed to determine the efficacy and safety of iberdomide in SLE. (Funded by Bristol Myers Squibb; ClinicalTrials.gov number, NCT03161483; EudraCT number, 2016-004574-17.).

Sections du résumé

BACKGROUND
Iberdomide, a cereblon modulator promoting degradation of the transcription factors Ikaros and Aiolos, which affect leukocyte development and autoimmunity, is being evaluated for the treatment of systemic lupus erythematosus (SLE).
METHODS
In this phase 2 trial, we randomly assigned patients in a 2:2:1:2 ratio to receive oral iberdomide (at a dose of 0.45, 0.30, or 0.15 mg) or placebo once daily for 24 weeks, in addition to standard medications. The primary end point at week 24 was a response on the SLE Responder Index (SRI-4), which was defined as a reduction of at least 4 points in the Systemic Lupus Erythematosus Disease Activity Index 2000 score (a 24-item weighted score of lupus activity that ranges from 0 to 105, with higher scores indicating greater disease activity), no new disease activity as measured on the British Isles Lupus Assessment Group 2004 index, and no increase of 0.3 points or more in the Physician's Global Assessment score (on a visual-analogue scale ranging from 0 [no disease activity] to 3 [maximal disease]).
RESULTS
A total of 288 patients received the assigned intervention: 81 received iberdomide at a dose of 0.45 mg, 82 received iberdomide at a dose of 0.30 mg, 42 received iberdomide at a dose of 0.15 mg, and 83 received placebo. At week 24, the percentages of patients with an SRI-4 response were 54% in the iberdomide 0.45-mg group, 40% in the iberdomide 0.30-mg group, 48% in the iberdomide 0.15-mg group, and 35% in the placebo group (adjusted difference between the iberdomide 0.45-mg group and the placebo group, 19.4 percentage points; 95% confidence interval, 4.1 to 33.4; P = 0.01), with no significant differences between the groups that received the lower doses of iberdomide and the group that received placebo. Iberdomide-associated adverse events included urinary tract and upper respiratory tract infections and neutropenia.
CONCLUSIONS
In this 24-week, phase 2 trial involving patients with SLE, iberdomide at a dose of 0.45 mg resulted in a higher percentage of patients with an SRI-4 response than did placebo. Data from larger, longer trials are needed to determine the efficacy and safety of iberdomide in SLE. (Funded by Bristol Myers Squibb; ClinicalTrials.gov number, NCT03161483; EudraCT number, 2016-004574-17.).

Identifiants

DOI: 10.1056/NEJMoa2106535 PMID: 35294813
pubmed: 35294813
doi: 10.1056/NEJMoa2106535
doi:

Substances chimiques

Adaptor Proteins, Signal Transducing 0
CRBN protein, human 0
IKZF3 protein, human 0
Morpholines 0
Phthalimides 0
Piperidones 0
Ikaros Transcription Factor 148971-36-2
iberdomide 8V66F27X44
Ubiquitin-Protein Ligases EC 2.3.2.27

Banques de données

ClinicalTrials.gov
['NCT03161483']
EudraCT
['2016-004574-17']

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1034-1045

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2022 Massachusetts Medical Society.

Auteurs

Joan T Merrill (JT)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Victoria P Werth (VP)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Richard Furie (R)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Ronald van Vollenhoven (R)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Thomas Dörner (T)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Milan Petronijevic (M)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Jorge Velasco (J)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Maria Majdan (M)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Fedra Irazoque-Palazuelos (F)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Michael Weiswasser (M)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Shimon Korish (S)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Ying Ye (Y)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Allison Gaudy (A)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Peter H Schafer (PH)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Zhaohui Liu (Z)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Nataliya Agafonova (N)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

Nikolay Delev (N)

From the Oklahoma Medical Research Foundation, Oklahoma City (J.T.M.); the University of Pennsylvania and the Corporal Michael J. Crescenz VA Medical Center - both in Philadelphia (V.P.W.); Northwell Health, Great Neck, NY (R.F.); Amsterdam University Medical Centers, Amsterdam (R.V.); Charité-Universitätsmedizin, Berlin (T.D.); the Military Medical Academy, Belgrade, Serbia (M.P.); Instituto Centro de Enfermedades Reumáticas, Buenos Aires (J.V.); Independent Public Clinical Hospital Number 4, Medical University of Lublin, Lublin, Poland (M.M.); Centro de Investigación y Tratamiento Reumatológico, Mexico City, Mexico (F.I.-P.); and Bristol Myers Squibb, Princeton, NJ (M.W., S.K., Y.Y., A.G., P.H.S., Z.L., N.A., N.D.).

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Classifications MeSH

questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Protéines et peptides de signalisation intracellulaire › Protéines adaptatrices de la transduction du signal › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes toxicologiques › Relation dose-effet des médicaments › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Acides aminés, peptides et protéines › Protéines › Facteurs de transcription › Facteurs de transcription Krüppel-like › Facteur de transcription Ikaros › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Maladies du système immunitaire › Maladies auto-immunes › Lupus érythémateux disséminé › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › Adulte d'âge moyen › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Oxazines › Morpholines › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Isoindoles › Phtalimides › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Composés hétérocycliques › Composés hétéromonocycliques › Pipéridines › Pipéridones › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes de santé › Indicateurs d'état de santé › Acuité des besoins du patient › Indice de gravité de la maladie › Phase 2 Trial of Iberdomide in Systemic Lupus...
questionsmedicales.fr › Enzymes et coenzymes › Enzymes › Ligases › Ubiquitin-protein ligase complexes › Ubiquitin-protein ligases › Phase 2 Trial of Iberdomide in Systemic Lupus...