Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis

Phase 4Not Yet RecruitingNCT05105347

Peking Union Medical College Hospital130 enrolled

Overview

This study is a multi-center randomized non-inferiority study that aims to observe the short-term (3 months) efficacy and safety of adalimumab plus medium-dose glucocorticosteroid (30mg/d prednisone or equivalent) with slow tapering for recurrent Behçet's uveitis (BU) attack compared with adalimumab plus high-dose glucocorticosteroid (60mg/d prednisone or equivalent) with slow tapering.

According to the most recent European League Against Rheumatism (EULAR) recommendation, patients presenting with an initial or recurrent episode of acute sight-threatening uveitis should be treated with high-dose glucocorticoids, infliximab or interferon-α. Adalimumab, another TNFα antagonist, is also considered as an alternative for infliximab and have proved its efficacy in several RCTs in the treatment of non-infectious intermediate, posterior and pan-uveitis. As higher dose glucocorticosteroid have greater side effects, this study aims to evaluate the non-inferior efficacy and safety of adalimumab plus medium-dose glucocorticosteroid compared with adalimumab plus high-dose glucocorticosteroid (and slow tapering) for recurrent posterior or pan-uveitis attack of Behcet's uveitis. Refractory BU is defined as relapse of posterior or panuveitis with at least 10mg daily prednisone (or equivalent). The acute attack will be controlled with adalimumab (80mg once, 40mg q2w thereafter) plus medium dose initial oral glucocorticosteroid (30mg daily prednisone or equivalent) in the "medium dose" group or plus high dose oral glucocorticosteroid (60mg daily prednisone or equivalent) in the "high dose" group with fixed tapering protocols. Patients will be followed up at 2w, 4w, 8w, and 12w after initiation of treatment. The primary endpoint is the inflammatory control rate. Secondary endpoints are BCVA, vascular leakage score on fundus fluorescein angiography (FFA), BOS 24 score and uveitis deterioration rate. The safety profiles of both groups will be also monitored.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Uveitis

Interventions

Adalimumab plus different doses of oral glucocorticosteroidDRUG

A loading dose of 80mg adalimumab will be given subcutaneously and then change to 40mg adalimumab every two weeks. Medium dose oral glucocorticosteroid (30mg/d prednisone or equivalent) will be given to the experimental dose group and high dose oral glucocorticosteroid (60mg/d prednisone or equivalent) will be given to the high dose group.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Behçet's disease (BD) patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis * The patient should be on ≥10mg/d oral prednisone or equivalent Exclusion Criteria: * Previous treatment with TNFα inhibitors within 3 months * Pregnancy, breast feeding women * Malignancy * Heart failure * Demyelinating diseases * Renal impairment (creatinine \> 1.5 mg/dl) * Depression or other psychic disorders * History of acute or chronic inflammatory joint or autoimmune disease * Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement * Organ or bone marrow transplant recipient, cardiac failure \> NYHA III * Acute liver disease with ALT or SGPT 2x above normal * White blood cell count \< 3500/mm\^3 * Platelet count \< 100000/mm\^3 * Hgb \< 8.5g/dl * T-SPOT TB: ≥200 SFCs per 10\^6 PBMC * Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of intermediate dose corticosteroids * Other severe ocular diseases or intraocular surgery within 3 months * Media opacity precluding a clear view of the fundus * Positive screen test for HBV, HCV, HIV infection or syphilis * Body weight \<45 kg * Alcohol abuse or drug abuse * Mental impairment * Uncooperative attitude

Outcomes

Primary Outcomes

Uveitis control

Inflammation control according to SUN criteria (two steps decrease of anterior chamber cell or vitreous haze or decreased to zero) or active retinal lesion recession with vitreous haze less than 0.5 grade

Time frame: 3 months

Secondary Outcomes

Best corrected visual acuity (BCVA)

BCVA was transformed into logMar form

Time frame: 3 months

Extent of vascular leakage

Vascular leakage was quantified based on the method developed by the Angiography Scoring for Uveitis Working Group (ASUWOG), in which vascular leakage in the posterior pole and in each peripheral quadrant was scored 1 if limited

Time frame: 3 months

BOS 24 score

BOS 24 scoring system refers to article "Behc et's disease ocular attack score 24: evaluation of ocular disease activity before and after initiation of infliximab

Time frame: 3 months

Uveitis deterioration

Inflammation deterioration according to SUN criteria (two steps increase of anterior chamber cell or vitreous haze or increases to grade 4) or new active retinal lesions or new onset of retinal vasculitis

Time frame: 3 months

Central Contacts

Hang Song, MD

CONTACT

+8615600612346 songhang_pumch@163.com

Chan Zhao, MD

CONTACT

+8613810454083 zhaochan@pumch.cn

Data from ClinicalTrials.gov

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