Asset Details
Do you wish to reserve the book?
IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study
Hey, we have placed the reservation for you!
By the way, why not check out events that you can attend while you pick your title.
Oops! Something went wrong.
Looks like we were not able to place the reservation. Kindly try again later.
Are you sure you want to remove the book from the shelf?
IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study
Do you wish to request the book?
IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study
Please be aware that the book you have requested cannot be checked out. If you would like to checkout this book, you can reserve another copy
We have requested the book for you!
Your request is successful and it will be processed during the Library working hours. Please check the status of your request in My Requests.
Oops! Something went wrong.
Looks like we were not able to place your request. Kindly try again later.
Journal Article
IFN-α kinoid in systemic lupus erythematosus: results from a phase IIb, randomised, placebo-controlled study
2020
Overview
ObjectiveTo evaluate the efficacy and safety of the immunotherapeutic vaccine interferon-α kinoid (IFN-K) in a 36-week (W) phase IIb, randomised, double-blind, placebo (PBO)-controlled trial in adults with active systemic lupus erythematosus (SLE) despite standard of care.MethodsPatients with SLE (185) with moderate to severe disease activity and positive interferon (IFN) gene signature were randomised to receive IFN-K or PBO intramuscular injections (days 0, 7 and 28 and W12 and W24). Coprimary endpoints at W36 were neutralisation of IFN gene signature and the BILAG-Based Composite Lupus Assessment (BICLA) modified by mandatory corticosteroid (CS) tapering.ResultsIFN-K induced neutralising anti-IFN-α2b serum antibodies in 91% of treated patients and reduced the IFN gene signature (p<0.0001). Modified BICLA responses at W36 did not statistically differ between IFN-K (41%) and PBO (34%). Trends on Systemic Lupus Erythematosus Responder Index-4, including steroid tapering at W36, favoured the IFN-K and became significant (p<0.05) in analyses restricted to patients who developed neutralising anti-IFN-α2b antibodies. Attainment of lupus low disease activity state (LLDAS) at W36 discriminated the two groups in favour of IFN-K (53% vs 30%, p=0.0022). A significant CS sparing effect of IFN-K was observed from W28 onwards, with a 24% prednisone daily dose reduction at W36 in IFN-K compared with PBO (p=0.0097). The safety profile of IFN-K was acceptable.ConclusionsIFN-K induced neutralising anti-IFN-α2b antibodies and significantly reduced the IFN gene signature with an acceptable safety profile. Although the clinical coprimary endpoint was not met, relevant secondary endpoints were achieved in the IFN-K group, including attainment of LLDAS and steroid tapering.Trial registration numberNCT02665364.
Publisher
Elsevier Limited
Subject
Adrenal Cortex Hormones - administration & dosage
/ Adult
/ Female
/ Humans
/ Immunologic Factors - administration & dosage
/ Interferon-alpha - administration & dosage
/ Interferon-alpha - immunology
/ Kinases
/ Lupus
/ Lupus Erythematosus, Systemic - blood
/ Lupus Erythematosus, Systemic - drug therapy
/ Lupus Erythematosus, Systemic - immunology
/ Male
/ Patients
/ Placebos
/ Safety
/ Steroids
/ Systemic lupus erythematosus
/ Vaccines
