For adult patients with moderate to severe chronic plaque psoriasis (Ps)

Open-label extension (OLE) analysis

Response rates in HUMIRA-treated patients at 3 years1-4


STUDY DESIGN INTRODUCTIONS

REVEAL was a 52-week randomized, double-blind, placebo-controlled trial of 1212 adult patients with moderate to severe chronic plaque psoriasis. In Period C, patients who maintained at least a PASI 75 response at week 33 and were originally randomized to HUMIRA 40 mg EOW in Period A were re-randomized to receive HUMIRA 40 mg or placebo EOW for an additional 19 weeks. Proportion of patients losing an adequate response after week 33 and on or before week 52 was also studied.1,2,5

View full study design
OLE Week 0 and 108 PGA, PASI 75, PASI 90, and PASI 100 response in patients who received continuous HUMIRA through week 52 and entered the OLE study.

  • OLE limitations: As with any long-term open-label extension (OLE), there are several limitations with the OLE portion of this study. For example, there is the potential for enrichment of the long-term data in the remaining patient population, as those who remain in the study generally fare better than those who discontinue.2
  • The use of HUMIRA in moderate to severe chronic plaque psoriasis beyond one year has not been evaluated in controlled clinical trials.1

  • OLE populations generally consist of treatment responders. Patients who are unable to tolerate or who do not respond to the drug often drop out.
  • Patient responses were analyzed relative to baseline of REVEAL.


*PGA of clear defined as no plaque elevation, no scale, plus or minus hyperpigmentation or diffuse pink or red coloration. Minimal defined as possible but difficult to ascertain whether there is slight elevation of plaque above normal skin, plus or minus surface dryness with some white coloration, plus or minus up to red coloration.1

PASI 75 represents a ≥75% improvement in skin clearance from baseline.
PASI 90 represents a ≥90% improvement in skin clearance from baseline.
§PASI 100 represents a 100% improvement in skin clearance from baseline.

BSA=body surface area; EOW=every other week; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; PGA=physician’s global assessment