Critical appraisal of adalimumab in the treatment of chronic plaque psoriasis

Figures & data

Table 1 A comparison of three Phase III clinical trials on the use of adalimumab for treating chronic plaque psoriasis

Study	Study design	Treatment duration and regimen
REVEAL^a (n=1,212)	Phase III randomized controlled study of adalimumab every-other-week dosing in patients with moderate to severe plaque psoriasis	52-week study Period A: 0–16 weeks (n=1,212); 814 received 80 mg at week 0 followed by 40 mg eow, 398 received placebo. Period B: 16–33 weeks (n=603); 578 continued on adalimumab 40 mg eow, 26 were switched from placebo to adalimumab 40 mg eow and 80 mg loading dose at week 16. Period C: 33–52 weeks (n=516); 490 participants originally on adalimumab from Period A were split into two groups – group i (n=250) received 40 mg eow, and group ii (n=240) were switched to placebo; 26 participants that started adalimumab in period B were continued on 40 mg eow.
CHAMPION^b (n=271)	Phase III randomized, double-blind, placebo-controlled study of the efficacy of adalimumab vs methotrexate vs placebo	16-week study Adalimumab group: (n=108), administered 80 mg loading dose, then 40 mg eow from week 1 to week 15. Methotrexate group: (n=110), received single weekly dose initiated at 7.5 mg per week, increased to a maximum of 25 mg per week (depending on response) Placebo: (n=53)
BELIEVE^c (n=730)	Phase IIIb randomized, double-blind, vehicle-controlled study of adalimumab with and without calcipotriol/betamethasone topical treatment	16-week study Adalimumab + calcipotriol/betamethasone group: (n=366) 80 mg loading dose of adalimumab at week 0 and then 40 mg eow, calcipotriol/betamethasone was applied daily for 4 weeks. Adalimumab + drug-free vehicle: (n=364) 80 mg loading dose of adalimumab at week 0 and then 40 mg eow; drug-free vehicle was applied daily for 4 weeks.

Notes:

a REVEAL¹², Randomized Controlled Evaluation of Adalimumab every-other-week dosing in moderate to severe psoriasis trial;

b CHAMPION¹⁶, Comparative study of Humira vs Methotrexate vs Placebo in Psoriasis patients;

c BELIEVE¹⁸, study of the efficacy and safety of adalimumab with and without calcipotriol/betamethasone topical treatment in patients with moderate to severe psoriasis.

Abbreviation: eow, every other week.

Table 2 Adverse events reported in ESPRIT data registry with rate ≥0.1 events/100 PYs in the all-Rx population

System organ class	All-Rx N=6,040
	N	%	PYs of obs duration n=12,400.9
			Events	E/100 PYs
Any SAE	419	6.9	694	5.6
Cardiac disorders	51	0.8	64	0.5
Infections	11	1.9	149	1.2
Abscesses	11	0.2	12	<0.1
Cellulitis	25	0.4	29	0.2
Pneumonia	18	0.3	18	0.1
TB	3	<0.1	3	<0.1
Neoplasm benign, malignant, and unspecified	76	1.3	90	0.7
SCC	9	0.1	18	0.1
Nervous system disorders	40	0.7	49	0.4
Skin and tissue disorders	17	0.3	20	0.2
Psoriasis	12	0.2	15	0.1

Abbreviations: PY, patient-year; SAE, serious adverse event; TB, tuberculosis; SCC, squamous cell carcinoma; obs, observation.

Menter A, Tyring SK, Gordon K, et al. Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled Phase III trial. J Am Acad Dermatol. 2008;58:106–115.

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Saurat J, Stingl G, Dubertret L, et al. Efficacy and safety results from the randomized controlled comparative study of adalimumab vs methotrexate vs placebo in patients with psoriasis (CHAMPION). Br J Dermatol. 2008;158:558–566.

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Thaci D, Ortonne JP, Chimenti S, et al. A Phase IIIb, multicentre, randomized, double-blind, vehicle-controlled study of the efficacy and safety of adalimumab with and without calcipotriol/betamethasone topical treatment in patients with moderate to severe psoriasis: the BELIEVE study. Br J Dermatol. 2010;163:402–411.

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