Long-term Benefit in Psoriasis With Monoclonal Antibody

Michael Vlessides

October 14, 2019

A novel humanized lgG1/k monoclonal antibody affords benefit for up to 4 years in some patients with moderate to severe plaque psoriasis, according to tildrakizumab investigators.

"Psoriasis is an individualized condition and it can be a challenge for clinicians to prescribe a medicine that's effective over time, especially for patients with comorbid conditions, like metabolic syndrome," Jeffrey Crowley, MD, from Bakersfield Dermatology in California, and lead investigator of the reSURFACE 1 study, said in a statement.

Results from the phase 3 reSURFACE 1 and reSURFACE 2 studies were reported in separate presentations (posters P1646 and P1647) at the 28th European Academy of Dermatology and Venereology Congress in Madrid.

The double-blind, randomized reSURFACE 1 trial (NCT01722331) evaluated tildrakizumab (Ilumya, Sun Pharma) in adults with moderate to severe chronic plaque psoriasis. After a 64-week base study of tildrakizumab 100 mg or 200 mg and placebo, responders and partial responders received tildrakizumab 100 mg or 200 mg for another 192 weeks.

reSURFACE 2 (NCT01729754) examined the safety and efficacy of tildrakizumab. After a 52-week base study of tildrakizumab 100 mg or 200 mg, etanercept 50 mg (Enbrel, Amgen), or placebo, responders and partial responders received tildrakizumab 100 mg or 200 mg out to week 244.

In these studies, more than half the participants achieved a reduction in Psoriasis Area Sensitivity Index score of at least 90% (PASI 90).

Table 1. Outcomes Achieved by Participants in the reSURFACE Studies
Outcome reSURFACE 1, % reSURFACE 2, %
PASI 75 82 89
PASI 90 56 64
PASI 100 28 35
Favorable Physician Global Assessment score 58 65

In fact, tildrakizumab 100 mg led to significant and durable improvements in PASI and Physician Global Assessment scores and was well tolerated. In addition, exposure-adjusted incident rates for many types of adverse event were either comparable to or numerically lower than placebo.

Recent studies have shown that patients with psoriasis have a higher incidence of metabolic syndrome. A systematic review and meta-analysis of this work suggests that metabolic syndrome worsens complications in psoriasis by predisposing patients to cardiovascular disease (Endocr Metab Immune Disord Drug Targets. Published online October 8, 2019).

Investigators advise that patients with psoriasis be routinely monitored for complications related to metabolic syndrome and associated risk factors, such as hypertension, elevated triglyceride levels, low levels of high-density-lipoprotein cholesterol, elevated fasting plasma glucose levels, and waist circumference above the normal range.

Two post hoc analyses of data from the reSURFACE 1 and 2 studies also presented looked at the efficacy of tildrakizumab in people with metabolic syndrome (posters P1653 and P1650). And at 3 years, 75% to 100% of skin clearance achieved with tildrakizumab was sustained to an equal extent in patients with and without metabolic syndrome.

Table 2. reSURFACE 1 Outcomes Achieved by Participants With and Without Metabolic Syndrome
Outcome With Metabolic Syndrome, % Without Metabolic Syndrome, %
PASI 75 69 71
PASI 90 42 51

reSURFACE 2 results for participants with and without metabolic syndrome were comparable to those of reSURFACE 1.

In addition, 3-year adverse event rates usually associated with metabolic syndrome were comparable in study participants with and without metabolic syndrome.

"These data provide confidence that tildrakizumab can help patients with moderate to severe plaque psoriasis, regardless of metabolic syndrome, achieve and maintain significant skin clearance over the long-term," Crowley added.

28th European Academy of Dermatology and Venereology (EADV) Congress: Posters P1646, P1647, P1650, P1653. Presented October 9, 2019.

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