Health Boards
Tofacitinib is a drug being investigated by Pfizer for the treatment of rheumatoid arthritis, psoriasis, inflammatory bowel disease, and other immunological diseases, as well as for the prevention of organ transplant rejection.
In November 2012 the U.S. Food and Drug Administration (FDA) approved it for treatment of rheumatoid arthritis. Tofacitinib is an inhibitor of the enzyme Janus kinase 3. More on that here: RE: I need more Psoriasis
Background:
Tofacitinib (CP-690,550) is a novel Janus kinase inhibitor in development as an oral formulation for the treatment of several inflammatory diseases including psoriasis.
Objectives:
This Phase 2a study aimed to assess the efficacy, systemic safety, local tolerability and systemic pharmacokinetics of topical tofacitinib in mild-to-moderate plaque psoriasis.
Methods:
Two tofacitinib ointment formulations were evaluated in this multicentre, double-blind, vehicle–controlled trial (NCT01246583). Seventy-one patients were randomised 2:1:2:1 to 2% tofacitinib Ointment 1, Vehicle 1, 2% tofacitinib Ointment 2 and Vehicle 2, each administered twice daily for 4 weeks to a single fixed 300 cm2 treatment area containing a target plaque +/- one or more non-target plaques and normal skin.
Results:
The primary endpoint of percent change from baseline in Target Plaque Severity Score at Week 4 demonstrated statistically significant improvement for Ointment 1 (least squares mean [LSM] –54.4%) vs Vehicle 1 (LSM –41.5%), but not Ointment 2 (LSM –24.2%) vs Vehicle 2 (LSM –17.2%). Secondary endpoints (Target Plaque Area and Itch Severity Item) improved similarly for tofacitinib ointment vs corresponding vehicle. Adverse event (AE) occurrence was similar across treatment groups. All AEs were mild or moderate and none were serious or led to subject discontinuation. One application site AE (erythema) was reported. Tofacitinib mean systemic exposure was minimal and was greater for Ointment 1 than for Ointment 2.
Conclusions:
Tofacitinib Ointment 1 was well tolerated and efficacious compared with vehicle for the treatment of plaque psoriasis. Further study of topical tofacitinib for psoriasis treatment is warranted.
Source: onlinelibrary.wiley.com
In November 2012 the U.S. Food and Drug Administration (FDA) approved it for treatment of rheumatoid arthritis. Tofacitinib is an inhibitor of the enzyme Janus kinase 3. More on that here: RE: I need more Psoriasis
Background:
Tofacitinib (CP-690,550) is a novel Janus kinase inhibitor in development as an oral formulation for the treatment of several inflammatory diseases including psoriasis.
Objectives:
This Phase 2a study aimed to assess the efficacy, systemic safety, local tolerability and systemic pharmacokinetics of topical tofacitinib in mild-to-moderate plaque psoriasis.
Methods:
Two tofacitinib ointment formulations were evaluated in this multicentre, double-blind, vehicle–controlled trial (NCT01246583). Seventy-one patients were randomised 2:1:2:1 to 2% tofacitinib Ointment 1, Vehicle 1, 2% tofacitinib Ointment 2 and Vehicle 2, each administered twice daily for 4 weeks to a single fixed 300 cm2 treatment area containing a target plaque +/- one or more non-target plaques and normal skin.
Results:
The primary endpoint of percent change from baseline in Target Plaque Severity Score at Week 4 demonstrated statistically significant improvement for Ointment 1 (least squares mean [LSM] –54.4%) vs Vehicle 1 (LSM –41.5%), but not Ointment 2 (LSM –24.2%) vs Vehicle 2 (LSM –17.2%). Secondary endpoints (Target Plaque Area and Itch Severity Item) improved similarly for tofacitinib ointment vs corresponding vehicle. Adverse event (AE) occurrence was similar across treatment groups. All AEs were mild or moderate and none were serious or led to subject discontinuation. One application site AE (erythema) was reported. Tofacitinib mean systemic exposure was minimal and was greater for Ointment 1 than for Ointment 2.
Conclusions:
Tofacitinib Ointment 1 was well tolerated and efficacious compared with vehicle for the treatment of plaque psoriasis. Further study of topical tofacitinib for psoriasis treatment is warranted.
Source: onlinelibrary.wiley.com
