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Risankizumab trumps ustekinumab, placebo for moderate-to-severe psoriasis

Audrey Abella
10 Dec 2020

The novel, humanized IgG1 monoclonal antibody risankizumab was superior to ustekinumab and placebo in reducing and potentially eliminating symptoms of moderate-to-severe chronic plaque psoriasis, according to two replicate phase III trials.

Apart from its quick onset and sustained long-term effects, risankizumab reduced psychological distress, leading to meaningful improvements in mental health and health-related quality of life (HRQoL), further boosting its promising potential in this setting, noted the researchers.

Integrated data from [UltIMMa-1 and UltIMMa-2 reflect the] treatment efficacy [of risankizumab] over time from a patient’s perspective through patient-reported outcomes (PROs),” said the researchers. In the era of patient-centred care … use of PROs is particularly relevant for chronic diseases such as psoriasis given the lifelong effect it has on patients.”

A total of 997 patients were randomized 3:1:1 to receive risankizumab 150 mg, ustekinumab 45 or 90 mg (weight-based), or matching placebo. Risankizumab and ustekinumab were given for 52 weeks; placebo was given for 16 weeks. [JAMA Dermatol 2020;doi:10.1001/jamadermatol.2020.3617]

 

PSS

Total PSS* score was significantly lower with risankizumab vs placebo as early as week 4 (mean, 4.3 to 7.4; p<0.001), which was sustained until week 16 (mean, 2.2 vs 8.0; p<0.001). Total PSS score was also lower with risankizumab vs ustekinumab at week 52 (mean, 1.2 vs 3.1; p<0.001).

A greater fraction of patients on risankizumab achieved PSS=0 (symptom-free) compared with patients on placebo at week 16 (30 percent vs 1 percent; p<0.001), and compared with those on ustekinumab at week 52 (p<0.001).

 

DLQI, HADS, EQ-5D-5L

At week 16, the percentages of MCID**-based DLQI*** (no impact on skin-related HRQoL) and HADS# responders were also greater with risankizumab compared with ustekinumab (94 percent vs 85 percent; p<0.001 [DLQI], 69 percent vs 57 percent; p=0.004 [HADS anxiety], and 71 percent vs 60 percent; p=0.01 [HADS depression]) and with placebo (94 percent vs 36 percent, 69 percent vs 36 percent, 71 percent vs 37 percent, respectively; p<0.001 for all).

The DLQI improvements with risankizumab vs ustekinumab were sustained by week 52 (96 percent vs 85 percent; p<0.001).

Multivariate analyses of the week-52 outcomes also favoured risankizumab over ustekinumab in terms of PSS=0 (odds ratio [OR], 2.69), MCID-based DLQI=0/1 (OR, 5.27), and DLQI (OR, 3.89; p<0.001 for all).

EQ-5D-5L## scores, although not a sensitive measurement for chronic plaque psoriasis, [Value Health 2013;16:1156-1162] improved in a significantly greater fraction of patients on risankizumab, both at week 16 (42 percent vs 32 percent; p=0.01 [vs ustekinumab] and 42 percent vs 19 percent; p<0.001 [vs placebo]) and at week 52 (44 percent vs 32 percent; p=0.002 [vs ustekinumab]).

Taken together, these PROs are essential for evaluating the efficacy of a certain treatment from a patient’s vantage point to augment data obtained from conventional assessments, noted the researchers.

 

Avoiding shame, stigma, stress

The appearance of plaque psoriasis may breed a sense of embarrassment, stigmatization, psychological distress, and eventual social isolation among afflicted patients. [Br J Dermatol 2005;153:1192-1199; J Investig Dermatol Symp Proc 2004;9:140-147; Dermatology 2006;212:123-127] “Its physical and psychosocial burden can substantially compromise social functioning, work and daily activity, and HRQoL of many patients with psoriasis, particularly those with moderate-to-severe disease,” said the researchers.

Overall, the findings underscore the potential of risankizumab to provide meaningful clinical and psychosocial benefits among individuals with moderate-to-severe psoriasis, they added.

The results also support available literature on other agents for plaque psoriasis which, despite having favourable outcomes, mostly reflect short-term results. [J Am Acad Dermatol 2015;73:400-409; Lancet 2015;386:541-551; J Dermatol Sci 2016;81:44-52; J Am Acad Dermatol 2017;76:405-417] “One of the strengths of the present study is the availability of longer timepoints at which PROs, including mental health impact, can be evaluated, allowing for both short- and long-term assessment,” noted the researchers.

 

 

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Most Read Articles
01 Dec 2020
Tetanus toxoid 5 Lf, diphtheria toxoid 2 Lf, pertussis toxoid 2.5 mcg, filamentous haemagglutinin 5 mcg, fimbriae types 2 and 3 5 mcg, pertactin 3 mcg
Dr. Hsu Li Yang, Dr. Tan Thuan Tong, Dr. Andrea Kwa, 08 Jan 2021
Antimicrobial resistance has become increasingly dire as the rapid emergence of drug resistance, especially gram-negative pathogens, has outpaced the development of new antibiotics. At a recent virtual symposium, Dr Hsu Li Yang, Vice Dean (Global Health) and Programme Leader (Infectious Diseases), NUS Saw Swee Hock School of Public Health, presented epidemiological data on multidrug-resistant (MDR) gram-negative bacteria (GNB) in Asia, while Dr Tan Thuan Tong, Head and Senior Consultant, Department of Infectious Diseases, Singapore General Hospital (SGH), focused on the role of ceftazidime-avibactam in MDR GNB infections. Dr Andrea Kwa, Assistant Director of Research, Department of Pharmacy, SGH, joined the panel in an interactive fireside chat, to discuss challenges, practical considerations, and solutions in MDR gram-negative infections. This Pfizer-sponsored symposium was chaired by Dr Ng Shin Yi, Head and Senior Consultant of Surgical Intensive Care, SGH.
Pearl Toh, 26 Nov 2020
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
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