However, studies in animals did not indicate toxicity. There are no data on dupilumab in pregnancy. There were two cases of serum sickness in people with high titres of anti-drug antibody. There were occasional elevations in eosinophils with dupilumab but these were usually transient. In the LIBERTY AD CHRONOS trial, keratitis occurred in 4% of patients treated with dupilumab and topical corticosteroid compared to none of the patients treated with placebo and topical corticosteroid.
These were less common in the placebo groups. The most common adverse events with dupilumab included injection-site reactions (9.6–15.9%), allergic conjunctivitis (3–7%), bacterial conjunctivitis (0.9–1.9%), blepharitis (0.4–4.5%), oral herpes (2.5–3.8%), eye pruritus (0.4–2.9%) and dry eye (0.2–1.8%). 1, 2 Efficacy was maintained at 52 weeks in the LIBERTY AD CHRONOS trial. More improvement of pruritus was also reported with dupilumab compared to placebo. This was compared to 8–12% in the corresponding placebo groups ( see Table).
#ECZEMA CREAM RX TRIAL#
After 16 weeks of treatment, 36–38% of people given dupilumab in the SOLO trials and 39% in the LIBERTY AD CHRONOS trial had reached the primary outcome. initial 600 mg dupilumab dose, followed by 300 mg each weekĪ primary outcome of the trials was the proportion of patients with an Investigator’s Global Assessment (IGA) score of 0 or 1 (clear or almost clear skin) and a reduction of at least 2 points in their IGA score from baseline, after 16 weeks of treatment.Īt baseline, 46–50% of patients had an IGA score of 4.an initial loading dose of dupilumab 600 mg subcutaneously as two injections, followed by a 300 mg dose every two weeks.Patients were randomised to one of three treatments: In total, 2119 people with moderate–severe atopic dermatitis (minimum of 10% body surface area involvement) were enrolled in the three trials. 1, 2 Efficacy in all three trials was measured at 16 weeks. SOLO-1 and SOLO-2 assessed dupilumab monotherapy for 16 weeks and LIBERTY AD CHRONOS assessed dupilumab with concomitant topical corticosteroids for 52 weeks. The safety and efficacy of dupilumab has been investigated in three main placebo-controlled phase III trials. Dupilumab inhibits signalling mediated by these cytokines by blocking their receptors. People with atopic dermatitis produce increased amounts of interleukin-4 and interleukin-13. Currently, oral immunosuppressants such as ciclosporin, azathioprine or methotrexate are used in severe atopic dermatitis. It is intended for long-term rather than episodic use and can be given with or without topical corticosteroids.
#ECZEMA CREAM RX FULL#
Please click to download full Prescribing Information.Pre-filled syringe containing 300 mg/2 mL solutionĭupilumab is a subcutaneously injected monoclonal antibody for people with moderate–severe atopic dermatitis who require systemic therapy. Store at controlled room temperature 68° to 77☏ (20° to 25☌), excursions permitted between 59° and 86☏ (15° and 30☌).įederal Law restricts this device to sale by or on the order of a physician or properly licensed practitioner. Do not use if seal has been punctured or is not visible. The opening of this product is covered by a metal seal. Patients with a known allergy to nuts or nut oils should consult their physician before using this topical preparation. Promiseb Topical Cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil).
Promiseb Topical Cream does not contain milk, wheat, peanut or animal derivatives. The use of Promiseb Topical Cream is contraindicated in any patient with known history of hypersensitivity to any of the ingredients. Promiseb Topical Cream is comprised of Purified Water, Isohexadecane, Butyrospermum parkii, Pentylene glycol, Ethylhexyl palmitate, Cera alba, PEG-30 Dipolyhydroxystearate, Bisabolol, Polyglyceryl-6, polyricinoleate, Tocopheryl acetate, Hydrogenated castor oil, Acifructol complex, Butylene glycol, Magnesium sulfate, Piroctone olamine, Allantoin, Magnesium stearate, Disodium EDTA, Vitis vinifera, Ascorbyl tetraisopalmitate, Glycyrrhetinic acid, Propyl gallate, and Telmesteine.
#ECZEMA CREAM RX SKIN#
If the skin is broken, cover Promiseb Topical Cream with a dressing of choice. Promiseb Topical Cream helps to relieve the dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.Īpply Promiseb Topical Cream to the affected skin areas 2 to 3 times per day (or as needed), and massage gently into the skin. Under the supervision of a healthcare professional, Promiseb Topical Cream is indicated to manage and relieve the signs and symptoms of seborrhea and seborrheic dermatitis such as itching, erythema, scaling and pain. Promiseb ® Topical Cream is an off-white, steroid-free, fragrance-free, water-based emulsion.
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