Combination Use of Ustekinumab With Other Systemic Therapies: A Retrospective Study in a Tertiary Referral Center

October 2013 | Volume 12 | Issue 10 | Original Article | 1098 | Copyright © October 2013

Gillian M. Heinecke BS, Adam J. Luber BA, Jacob O. Levitt MD, and Mark G. Lebwohl MD

Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY

Abstract
BACKGROUND: Patients with moderate to severe psoriasis may not respond adequately to single systemic agent and may require combination systemic therapy.
OBJECTIVE: To evaluate the prevalence, indications, and response to combination systemic therapy with ustekinumab for psoriasis in a tertiary referral center.
METHODS: This retrospective study comprised 102 psoriasis patients treated with ustekinumab at a single tertiary care center. Data was collected pertaining to history of psoriasis, past and current therapies including use of concomitant psoriasis agents, response to therapy, and side effects while on ustekinumab.
RESULTS: Twenty-two of 102 (22%) patients were identified as receiving combination systemic treatment involving ustekinumab and at least one additional agent. The most common indication for combination therapy was psoriatic arthritis (35%), followed by bridging therapy (26%), inadequate psoriasis control (13%), prevention of non-melanoma skin cancers (17%), and control of palmoplantar disease (9%). Methotrexate was the additional agent in 12 patients, cyclosporine in 7 patients, acitretin in 5 patients, and 1 patient received a second biologic agent, first etanercept and then adalimumab. Overall, the reduction in body surface area (BSA) was 80% for patients on combination therapy. For those patients on combination therapy for psoriatic arthritis, 75% had resolution or stabilization of their symptoms. Only one patient, receiving cyclosporine, discontinued combination therapy due to adverse side effects.
CONCLUSION: Combination systemic therapy with ustekinumab can be effective and well tolerated for patients who cannot be adequately treated with ustekinumab alone.

J Drugs Dermatol. 2013;12(10):1098-1102.

INTRODUCTION

Psoriasis is a chronic inflammatory condition affecting 3% of the United States population.1 While most cases are mild and are successfully managed with topical medications, 17% of patients have moderate to severe disease, which typically requires treatment with phototherapy or systemic agents.1 These systemic therapies consist of traditional agents, including methotrexate, cyclosporine, and acitretin, and newer biological agents, including tumor necrosis factor-alpha (TNF-α) and interleukin (IL)-12 and 23 inhibitors. In some patients, a single systemic agent does not provide adequate clearance, necessitating treatment with multiple systemic agents to enhance efficacy.2 The addition of a traditional systemic agent to a biologic regimen may also be indicated in the case of complications or comorbid conditions. For example, methotrexate is often combined with biologics to aid in the treatment of concurrent psoriatic arthritis,3,4 and acitretin may be added to patients at risk for non-melanoma skin cancer (NMSC).5 Studies from Europe report that up to 30% of psoriasis patients on anti-TNF-α therapy receive a concomitant traditional systemic agent.6,7
While there are multiple studies supporting the use of TNF-α inhibitors with traditional systemic agents,3,8-10 the literature describing the use of combination therapy with the newest FDA-approved biologic agent, ustekinumab is limited.11,12 Ustekinumab is a fully human monoclonal IgG antibody that binds to the shared p40 subunit of IL-12 and IL-23.13 In this study, we retrospectively investigated the use of combination systemic therapy with ustekinumab.

PATIENTS AND METHODS

This retrospective study involved review of the clinical records of psoriasis patients treated with ustekinumab at the Depart-