Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study
Abstract Background Psoriasis is a chronic immune-mediated inflammatory skin disease for which biologics are effective treatments. Dose reduction (DR) of the first generation biologics seems a promising way for more efficient use of expensive biologics. A substantial part of patients on tumor necros...
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| Format: | Article |
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BMC
2021-10-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05681-z |
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| author | Lara S. van der Schoot Juul M. P. A. van den Reek Lynda Grine Lisa Schots Wietske Kievit Jo L. W. Lambert Elke M. G. J. de Jong |
| author_facet | Lara S. van der Schoot Juul M. P. A. van den Reek Lynda Grine Lisa Schots Wietske Kievit Jo L. W. Lambert Elke M. G. J. de Jong |
| author_sort | Lara S. van der Schoot |
| collection | DOAJ |
| description | Abstract Background Psoriasis is a chronic immune-mediated inflammatory skin disease for which biologics are effective treatments. Dose reduction (DR) of the first generation biologics seems a promising way for more efficient use of expensive biologics. A substantial part of patients on tumor necrosis factor (TNF)-alfa inhibitors and ustekinumab could successfully lower their dose, after following a tightly controlled DR strategy. The objective of this study is to assess whether controlled DR of interleukin (IL)-17 and IL-23 inhibitors in psoriasis patients with low disease activity is non-inferior (NI) to usual care (UC). Methods This is an international, prospective, multicenter, pragmatic, randomized, non-inferiority trial. A total of 244 patients with stable low disease activity (Psoriasis Area and Severity Index (PASI) ≤ 5) for at least 6 months and using secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, or tildrakizumab in the standard dose, together with stable low disease activity, defined as a PASI ≤ 5 and Dermatology Life Quality Index (DLQI) ≤ 5 at the moment of inclusion, will be randomized 2:1 to DR or UC. In the DR group, dosing intervals will be prolonged stepwise to achieve 66% and 50% of the original dose. Disease activity is monitored every 3 months by PASI and DLQI. In case of disease flare (i.e., PASI and/or DLQI increase), treatment is adjusted to the previous effective dose. The primary outcome is the incidence proportion of persistent flares (PASI > 5 for ≥ 3 months), which will be compared between arms. Secondary outcomes include proportion of patients with successful DR, (course of) PASI and DLQI, serious adverse events (SAEs), health-related quality of life, costs, and pharmacokinetic profile. Outcomes of DR will be compared to UC. Discussion With this study, we aim to assess whether DR of IL-17 and IL-23 inhibiting biologics can be achieved for psoriasis patients with low disease activity, without losing disease control. Reducing the dose may lead to more efficient use of biologics. Trial registration ClinicalTrials.gov NCT04340076 . Registered on April 9 2020. |
| first_indexed | 2024-12-17T21:31:51Z |
| format | Article |
| id | doaj.art-ab7d40e11f4f41fcafe65e91de08034d |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T21:31:51Z |
| publishDate | 2021-10-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ab7d40e11f4f41fcafe65e91de08034d2022-12-21T21:31:52ZengBMCTrials1745-62152021-10-0122111210.1186/s13063-021-05681-zDose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio studyLara S. van der Schoot0Juul M. P. A. van den Reek1Lynda Grine2Lisa Schots3Wietske Kievit4Jo L. W. Lambert5Elke M. G. J. de Jong6Radboud University Medical Center, Department of DermatologyRadboud University Medical Center, Department of DermatologyDepartment of Dermatology, Ghent University HospitalDepartment of Dermatology, Ghent University HospitalRadboud University Medical Center, Department for Health EvidenceDepartment of Dermatology, Ghent University HospitalRadboud University Medical Center, Department of DermatologyAbstract Background Psoriasis is a chronic immune-mediated inflammatory skin disease for which biologics are effective treatments. Dose reduction (DR) of the first generation biologics seems a promising way for more efficient use of expensive biologics. A substantial part of patients on tumor necrosis factor (TNF)-alfa inhibitors and ustekinumab could successfully lower their dose, after following a tightly controlled DR strategy. The objective of this study is to assess whether controlled DR of interleukin (IL)-17 and IL-23 inhibitors in psoriasis patients with low disease activity is non-inferior (NI) to usual care (UC). Methods This is an international, prospective, multicenter, pragmatic, randomized, non-inferiority trial. A total of 244 patients with stable low disease activity (Psoriasis Area and Severity Index (PASI) ≤ 5) for at least 6 months and using secukinumab, ixekizumab, brodalumab, guselkumab, risankizumab, or tildrakizumab in the standard dose, together with stable low disease activity, defined as a PASI ≤ 5 and Dermatology Life Quality Index (DLQI) ≤ 5 at the moment of inclusion, will be randomized 2:1 to DR or UC. In the DR group, dosing intervals will be prolonged stepwise to achieve 66% and 50% of the original dose. Disease activity is monitored every 3 months by PASI and DLQI. In case of disease flare (i.e., PASI and/or DLQI increase), treatment is adjusted to the previous effective dose. The primary outcome is the incidence proportion of persistent flares (PASI > 5 for ≥ 3 months), which will be compared between arms. Secondary outcomes include proportion of patients with successful DR, (course of) PASI and DLQI, serious adverse events (SAEs), health-related quality of life, costs, and pharmacokinetic profile. Outcomes of DR will be compared to UC. Discussion With this study, we aim to assess whether DR of IL-17 and IL-23 inhibiting biologics can be achieved for psoriasis patients with low disease activity, without losing disease control. Reducing the dose may lead to more efficient use of biologics. Trial registration ClinicalTrials.gov NCT04340076 . Registered on April 9 2020.https://doi.org/10.1186/s13063-021-05681-zPsoriasisDose reductionBiologicsNon-inferiorityIL-17 inhibitorsIL-23 inhibitors |
| spellingShingle | Lara S. van der Schoot Juul M. P. A. van den Reek Lynda Grine Lisa Schots Wietske Kievit Jo L. W. Lambert Elke M. G. J. de Jong Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study Trials Psoriasis Dose reduction Biologics Non-inferiority IL-17 inhibitors IL-23 inhibitors |
| title | Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study |
| title_full | Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study |
| title_fullStr | Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study |
| title_full_unstemmed | Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study |
| title_short | Dose reduction of the new generation biologics (IL-17 and IL-23 inhibitors) in psoriasis: study protocol for an international, pragmatic, multicenter, randomized, controlled, non-inferiority study—the BeNeBio study |
| title_sort | dose reduction of the new generation biologics il 17 and il 23 inhibitors in psoriasis study protocol for an international pragmatic multicenter randomized controlled non inferiority study the benebio study |
| topic | Psoriasis Dose reduction Biologics Non-inferiority IL-17 inhibitors IL-23 inhibitors |
| url | https://doi.org/10.1186/s13063-021-05681-z |
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