Efficacy and Safety of Oral Alitretinoin (Toctino®) in the Treatment of Patients With Cutaneous Lupus Erythematosus (AliCLE)

Inclusion Criteria:

• A clinical and histological diagnosis of CLE (DLE, SCLE, LET) who failed to respond to topical corticosteroids;
• Total RCLASI activity score of skin lesions >6 (at least 3 points in at least 2 locations);
• At least one primary but preferably 2 methods of contraception;

Exclusion Criteria:

• Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
• Clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
• Active severe infection diseases, including chronic or localized;

• Patients with hepatic insufficiency (AST, ALT > 2.5 x ULN), severe renal failure (creatinine clearance < 60ml/min), or hypercholesterolemia characterized by:

  1. Fasting triglyceridemia > 1.5 x upper limit of normal (ULN)
  2. Fasting total cholesterol > 1.5 x ULN
  3. Fasting low-density lipoprotein (LDL) cholesterol > 1.5x ULN
• Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil;
• Patients with cardiovascular risk factors that would exclude a starting dose of 30 mg of alitretinoin;
• Topical corticosteroids within 14 days prior to dosing;
• Patients treated with any systemic or topical retinoids within 4 weeks before start of study treatment;
• Drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John‟s Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment;
• Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class and half-life);
• Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
• Concomitant medication with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolbutamide;
• Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;

Other protocol-defined inclusion/exclusion criteria may apply