Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial.
J Dermatol Sci. 2010 Jul; 59(1):40-9.JD

Abstract

BACKGROUND

A clinical trial of infliximab in psoriasis has not yet been performed in Asian populations, although infliximab has been approved for the indications of psoriatic arthritis and plaque psoriasis in the US and the EU.

OBJECTIVE

This study aims to validate the efficacy and safety of infliximab in Japanese patients with plaque psoriasis and psoriatic arthritis.

METHODS

Patients with moderate-to-severe psoriasis, including psoriatic arthritis, were randomized to the induction therapy (Weeks 0, 2 and 6) with infliximab 5 mg/kg (n=37) or placebo (n=17). For the maintenance therapy, infliximab was administered every 8 weeks from Week 14 to Week 62 in the infliximab group, and placebo was switched to infliximab in the placebo group starting at Week 16. The primary efficacy endpoint was the proportion of patients who had achieved at least 75% improvement in the psoriasis area and severity index (PASI 75 response rate) from baseline at Week 10.

RESULTS

At Week 10, a total of 68.6% of patients receiving infliximab and none of those receiving placebo, achieved PASI 75 response (p<0.001). A significant improvement in PASI, PGA, DLQI, and patient's pain assessment was seen from Week 6 through Week 14 in the infliximab group compared with the placebo group. Through Week 66, PASI, PGA, DLQI as well as pain relief were better maintained.

CONCLUSION

Infliximab could provide a sustained improvement effect on skin and joint symptoms, and accordingly contributed to a sustained improvement in the QOL of patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Infliximab was generally well tolerated in most patients. These results corresponded with the results of the trials in the US and the EU.

Links

Publisher Full Text

Aggregator Full Text

Authors+Show Affiliations

Torii H

Division of Dermatology, Social Insurance Central General Hospital, and Department of Dermatology, The Jikei University School of Medicine, 3-22-1 Hyakunincho, Shinjyuku, Tokyo 169-0073, Japan. toriimd@shahochu.jp

Nakagawa H

No affiliation info available

Japanese Infliximab Study investigators

No affiliation info available

MeSH

AgedAntibodiesAntibodies, MonoclonalArthralgiaArthritis, PsoriaticDermatologic AgentsFemaleHumansImmunosuppressive AgentsInfliximabMaleMiddle AgedPainPsoriasisQuality of LifeSeverity of Illness IndexTreatment Outcome

Pub Type(s)

Clinical Trial, Phase III

Journal Article

Multicenter Study

Randomized Controlled Trial

Language

eng

PubMed ID

20547039

Citation

Torii, Hideshi, et al. "Infliximab Monotherapy in Japanese Patients With Moderate-to-severe Plaque Psoriasis and Psoriatic Arthritis. a Randomized, Double-blind, Placebo-controlled Multicenter Trial." Journal of Dermatological Science, vol. 59, no. 1, 2010, pp. 40-9.

Torii H, Nakagawa H, Japanese Infliximab Study investigators. Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. J Dermatol Sci. 2010;59(1):40-9.

Torii, H., & Nakagawa, H. (2010). Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. Journal of Dermatological Science, 59(1), 40-9. https://doi.org/10.1016/j.jdermsci.2010.04.014

Torii H, Nakagawa H, Japanese Infliximab Study investigators. Infliximab Monotherapy in Japanese Patients With Moderate-to-severe Plaque Psoriasis and Psoriatic Arthritis. a Randomized, Double-blind, Placebo-controlled Multicenter Trial. J Dermatol Sci. 2010;59(1):40-9. PubMed PMID: 20547039.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial. AU - Torii,Hideshi, AU - Nakagawa,Hidemi, AU - ,, Y1 - 2010/05/04/ PY - 2010/02/01/received PY - 2010/04/05/revised PY - 2010/04/24/accepted PY - 2010/6/16/entrez PY - 2010/6/16/pubmed PY - 2010/10/5/medline SP - 40 EP - 9 JF - Journal of dermatological science JO - J Dermatol Sci VL - 59 IS - 1 N2 - BACKGROUND: A clinical trial of infliximab in psoriasis has not yet been performed in Asian populations, although infliximab has been approved for the indications of psoriatic arthritis and plaque psoriasis in the US and the EU. OBJECTIVE: This study aims to validate the efficacy and safety of infliximab in Japanese patients with plaque psoriasis and psoriatic arthritis. METHODS: Patients with moderate-to-severe psoriasis, including psoriatic arthritis, were randomized to the induction therapy (Weeks 0, 2 and 6) with infliximab 5 mg/kg (n=37) or placebo (n=17). For the maintenance therapy, infliximab was administered every 8 weeks from Week 14 to Week 62 in the infliximab group, and placebo was switched to infliximab in the placebo group starting at Week 16. The primary efficacy endpoint was the proportion of patients who had achieved at least 75% improvement in the psoriasis area and severity index (PASI 75 response rate) from baseline at Week 10. RESULTS: At Week 10, a total of 68.6% of patients receiving infliximab and none of those receiving placebo, achieved PASI 75 response (p<0.001). A significant improvement in PASI, PGA, DLQI, and patient's pain assessment was seen from Week 6 through Week 14 in the infliximab group compared with the placebo group. Through Week 66, PASI, PGA, DLQI as well as pain relief were better maintained. CONCLUSION: Infliximab could provide a sustained improvement effect on skin and joint symptoms, and accordingly contributed to a sustained improvement in the QOL of patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. Infliximab was generally well tolerated in most patients. These results corresponded with the results of the trials in the US and the EU. SN - 1873-569X UR - https://www.unboundmedicine.com/medline/citation/20547039/Infliximab_monotherapy_in_Japanese_patients_with_moderate_to_severe_plaque_psoriasis_and_psoriatic_arthritis__A_randomized_double_blind_placebo_controlled_multicenter_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0923-1811(10)00135-0 DB - PRIME DP - Unbound Medicine ER -

Tags

Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomized, double-blind, placebo-controlled multicenter trial.J Dermatol Sci. 2010 Jul; 59(1):40-9.JD