Tight controlled dose reduction of biologics in psoriasis patients with low disease activity: a randomized pragmatic non-inferiority trial

AbstractDose reduction (DR) of biologics, where possible, seems promising for more efficient use of expensive biologics. For implementation of DR strategies, it is essential to get insight in factors that influence implementation. The objective of this study was to evaluate the attitudes and behaviour regarding dose reduction of biologic therapies for psoriasis among psoriasis expert dermatologists worldwide. A 27-question e-survey was sent through the International Psoriasis Council (IPC) to its 114 dermatologist councilors worldwide. The survey assessed demographics, general and DR prescription behaviour, and motivations for and barriers against application of DR. Of 57 respondents, 53 respondents who prescribed biologics were included for analysis. Thirty-seven (69.8%) applied DR (i.e., ‘DR dermatologists’), and 16 (30.2%) did not (i.e., ‘Non-DR dermatologists’). DR strategies varied among respondents. Regarding criteria for starting DR, differences were reported in required treatment duration, and interpretation and duration of stable low disease activity. In addition, the prolongation of intervals between injections varied between respondents. For most ‘DR dermatologists’ (n = 32/37, 86.5%), cost savings were one of the main reasons to apply DR. Fifteen out of 16 ‘Non-DR dermatologists’ (94%) did not apply DR due to lack of scientific evidence. In conclusion, DR of biologics for psoriasis is part of clinical practice in psoriasis experts globally. Barriers for applying DR included lack of evidence or guidelines, and uncertainty on DR effects and risks. Although growing evidence shows DR feasibility, future studies are needed to accumulate and broaden evidence, along with development of (inter)national guidelines on DR strategies.

Download Full-text

THU0422 Effectiveness of Dose Reduction of TNF Inhibitors in Maintaining Low Disease Activity in Severe Psoriatic Arthritis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2015-eular.3523 ◽

2015 ◽

Vol 74 (Suppl 2) ◽

pp. 351.2-352

Author(s):

W. Fong ◽

C. Holroyd ◽

B. Davidson ◽

R. Armstrong ◽

N. Harvey ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Dose Reduction ◽

Tnf Inhibitors ◽

Low Disease Activity

Download Full-text

FRI0120 Serum calprotectin is not predictive for successful dose reduction or discontinuation of tnf inhibitors in ra patients with low disease activity

10.1136/annrheumdis-2017-eular.1729 ◽

2017 ◽

Author(s):

N Den Broeder ◽

L Tweehuysen ◽

T Vogl ◽

N van Herwaarden ◽

FHJ van den Hoogen ◽

...

Keyword(s):

Disease Activity ◽

Dose Reduction ◽

Tnf Inhibitors ◽

Low Disease Activity

Download Full-text

THU0244 Effectiveness of Dose Reduction of TNF Inhibitors in Maintaining Low Disease Activity in Severe Ankylosing Spondylitis

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2015-eular.1496 ◽

2015 ◽

Vol 74 (Suppl 2) ◽

pp. 285.3-286

Author(s):

W. Fong ◽

C. Holroyd ◽

B. Davidson ◽

R. Armstrong ◽

N. Harvey ◽

...

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Dose Reduction ◽

Tnf Inhibitors ◽

Low Disease Activity

Download Full-text

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 ◽

10.1186/s13063-021-05681-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lara S. van der Schoot ◽

Juul M. P. A. van den Reek ◽

Lynda Grine ◽

Lisa Schots ◽

Wietske Kievit ◽

...

Keyword(s):

Disease Activity ◽

Dose Reduction ◽

Standard Dose ◽

Life Quality ◽

Severity Index ◽

Pharmacokinetic Profile ◽

Substantial Part ◽

Serious Adverse Events ◽

Low Disease Activity ◽

Link Type

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.govNCT04340076. Registered on April 9 2020.

Download Full-text