Ustekinumab safe, effective in Asians with moderate to severe plaque psoriasis

Ustekinumab, a human monoclonal antibody that binds to the p40 subunit of both interleukin (IL)-12 and IL-23, demonstrates effectiveness and safety in the treatment of multiethnic Asian patients with moderate to severe plaque psoriasis, according to a Singapore study.

“Ustekinumab was well tolerated by our multiracial population with moderate to severe plaque psoriasis,” the researchers said. “There were no reports of injection-site side effects or serious allergic reactions, or common adverse events including nasopharyngitis, arthralgia, and headache.”

Adults with chronic plaque psoriasis prescribed with ustekinumab in a tertiary dermatologic centre between December 2009 and December 2015 were included in this retrospective study. Efficacy endpoint was the achievement of at least 50 percent and 75 percent improvement from baseline psoriasis area and severity index (PASI) and body surface area (BSA) at weeks 4 and 16.

Of the 99 eligible patients (69 percent Chinese, 15 percent Indians, and 9 percent Malay), 31 had documented PASI score and 55 had recorded BSA improvements. [Singapore Med J 2022;doi:10.11622/smedj.2022029]

Of those with documented PASI scores, 29 (93.5 percent) achieved PASI 50 and 21 (67.7 percent) achieved PASI 75 at week 16. Among patients with recorded BSA, 43 (78.2 percent) had at least 50 percent BSA improved, while 31 (56.4 percent) achieved 75-percent improvement at week 16.

None of the patients experienced a reactivation of their tuberculosis. Eleven of the 99 patients (11 percent) had latent tuberculosis infection (LTBI) and received prophylactic isoniazid. Likewise, no patient had serious adverse events. Cardiovascular events, cutaneous malignancies, or deaths were also not reported over 6 years.

However, one case of upper respiratory tract infection (URTI) after injection was reported. Information and recall bias was possible, since nasopharyngitis and URTI were the most common side effects reported by 7.3‒11.5 percent and 4.4‒8.5 percent of patients treated with ustekinumab. [Lancet 2008;371:1675-1684; J Dermatol Sci 2011;63:154-163]

“The efficacy of ustekinumab in biologic-naive patients has been shown to be higher than in non-naive patients,” the researchers said. “Previous biologic therapy in our patients included etanercept, adalimumab, and infliximab.” [Ann Rheum Dis 2014;73:990-999]

In earlier studies that assessed other biologic therapies, results were as follows: 48 percent of patients on etanercept achieved PASI 75 at week 12, 53 percent on adalimumab achieved PASI 75 at week 12, 72 percent on infliximab achieved PASI 75 at week 10, and 81.6 percent on secukinumab achieved PASI 75 at week 12. [N Engl J Med 2003;349:2014-2022; J Am Acad Dermatol 2006;55:598-606; J Am Acad Dermatol 2004;51:534-542; N Engl J Med 2014;371:326-328]

The current study was limited by its retrospective nature, and only 31 patients had a recorded PASI score. In addition, it was possible that the low incidence of adverse events, such as nasopharyngitis and URTI, was caused by recall or information bias.

“Psoriasis is a chronic inflammatory skin condition that affects 1–3 percent of the world’s population,” the researchers said. “Patients with psoriasis can experience a burden on their quality of life and are at higher risk of comorbidities such as obesity, hypertension, insulin resistance, and coronary heart disease.” [N Engl J Med 2005;352:1899-1912; Am J Clin Dermatol 2005;6:383-392; Br J Dermatol 2007;157:649-655]