Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus (ORDI-02)

Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus

Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous involvement at some point during course of their disease. In spite of the esthetic consequence during the acute phase, the main problem is still related to its disfiguring and incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the conventional therapy. Unfortunately, approximately 30% will be refractory to these measures. For those patients, immunosuppressive therapy can be an alternative with controversial results. Several series have shown a 90% of clinical efficacy in patients treated with Thalidomide. Unfortunately, the main drawback has been the serious described side effects such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide analogue, more potent, efficient and with better safety profile has been discovered. The main objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve patients with refractory cutaneous lupus will be included. Lenalidomide will be started at 5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the end of follow up.

Study Overview

• Status: Completed
• Conditions: Cutaneous Lupus
• Intervention / Treatment: Drug: Lenalidomide

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 18 years
• Histologically proven cutaneous lupus erythematosus with or without associated systemic disease
• Presence of at least a grade II erythema as assessed by the validated modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
• Cutaneous lesions involving more than 18% of the body surface calculated according to the rule of the nines, or history of severe side effects or lack of efficacy following thalidomide therapy, in cutaneous lupus disease refractory to conventional treatment with antimalarials and topical steroids.
• No pregnancy or wish to become pregnant during the study period.

Exclusion Criteria:

• Pregnancy, breastfeeding or the use of not adequate contraception.
• Severe thrombocytopenia (<30x10E9 cells/L) or leucopoenia (<1500x10E9), known at least 30 days prior to the onset of the study,
• Previous history of arterial/venous thrombosis,
• Presence of antiphospholipid antibodies
• Presence of moderate-severe renal impairment (FG <30 ml/min)
• Progressive renal disease.
• Lack of written informed consent prior to participation in the study.
• Presence of a concomitant systemic flare that may require other systemic treatments for its control
• Any psychiatric o social disease that may interfere with the study and follow-up
• HIV, B or C hepatitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lenalidomide Group	Drug: Lenalidomide; 5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving a complete response	Clinical response will be evaluated by the validated CLASI score. Complete response will be considered when CLASI score=0 following treatment.	3 months
Proportion of patients developing a side effect		12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients developing a systemic lupus flare	Systemic activity will be assess by the SLEDAI score. Disease activity will be considered with a SLEDAI score > or = 6.	6 months
Proportion of patients increasing anti-dsDNA levels	Anti-dsDNA titers will be mesured by ELISA at each visist.	12 months
Proportion of patients having a cutaenous flare following treatment withdrawal	Cutaneous flare will be defined by at least one CLASi > or= 2 in those patients with a previous complete resolution of the inflammatory rash (CLASI=0)	12 months
Proportion of patients with an increase CLASI damage score following treatment.	Sequelae will be evaluated but the CLASI score, damage area. Any increase in the score compared to initial scores will be considered as sequelae.	12 months

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Investigators: Principal Investigator: JOSEP ORDI-ROS, M, Vall d'Hebron Hospital

Publications and helpful links

General Publications

• Cortes-Hernandez J, Avila G, Vilardell-Tarres M, Ordi-Ros J. Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus. Arthritis Res Ther. 2012 Dec 7;14(6):R265. doi: 10.1186/ar4111.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): August 3, 2011
• Last Update Submitted That Met QC Criteria: August 2, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Lenalidomide; Refractory Cutaneous Lupus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: 2009-016508-21