Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.

Phramongkutklao College of Medicine and Hospital20 enrolled

Overview

This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (\< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Lupus Erythematosus, SLE

Interventions

Glucocorticoid withdrawal groupBEHAVIORAL

Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks

Glucocorticoid maintenance groupBEHAVIORAL

Daily 5-mg prednisolone over 24 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged; 20 years * Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012. * Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months. * Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization. Exclusion Criteria: * Pregnant or pregnancy planning * Unable to follow the schedules * Overlap with other autoimmune disease, except secondary SjS and APS * Co-morbid with any other condition which required prednisolone treatment * Documented adrenal insufficiency

Locations (1)

Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine

Bangkok, Thailand

Outcomes

Primary Outcomes

Any flare according any of 3 definitions

Flare definition: 1. Clinical SLEDAI 2K (excluding serology) ≥ 4, 2. Increase in SLE-DAS ≥ 1.72, 3. Increase in clinical SLEDAI-2K plus treatment escalation (including with NSAIDS, glucocorticoids (topical or oral), antimalarials, or immunosuppressants.

Time frame: 24 weeks

Secondary Outcomes

Any increase in clinical SLEDAI-2K

Percentage of participants with any increase in clinical SLEDAI-2K

Time frame: 24 weeks

Any changes in immunology

Percentage of participants with the decrease of C3 or C4 by 50% and/or the increase of anti-dsDNA by 25% as compared with baseline

Time frame: 24 weeks

Any increase in damage accrual

Percentage of participants with any increase in Systemic Lupus International Collaborating Clinic/American College of Rheumatology Damage Index (SDI) Score.

Time frame: 24 weeks

Changes in quality of life

Changes in Score of Systemic Lupus Erythematosus Quality Of Life (SLEQoL) Questionnaire (mean difference)

Time frame: 24 weeks

Data from ClinicalTrials.gov

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