Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study

Papp, Kim; Menter, Alan; Strober, Bruce; Langley, Richard; Buonanno, M.; Wołk, Robert; Gupta, Pankaj; Krishnaswami, Sriram; Tan, Huaming; Harness, Jane

doi:10.1111/j.1365-2133.2012.11168.x

Cited by 297 publications

(244 citation statements)

References 20 publications

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“…disorders, in which adverse events, particularly those that are hematologically related, are understandably more frequent (11)(12)(13), and are consistent with findings from use of tofacitinib in the treatment of patients with psoriasis (14)(15)(16)(17)(18)(19). The occurrence of hair shedding in responders following drug cessation suggests that maintenance therapy may be required to sustain remissions.…”

Section: L I N I C a L M E D I C I N Esupporting

confidence: 66%

Oral ruxolitinib induces hair regrowth in patients with moderate-to-severe alopecia areata

Mackay‐Wiggan¹,

Jabbari²,

Nguyen³

et al. 2016

JCI Insight

242

202

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IntroductionAlopecia areata (AA) is a major medical problem and is among the most prevalent autoimmune disease in the US, with a lifetime risk of 1.7% (1). AA affects both sexes across all ethnicities and represents the second most common form of human hair loss, second only to androgenetic alopecia (2). AA usually presents with patchy hair loss. One-third of these patients will experience spontaneous remissions within the first year. However, many patients' disease will progress to alopecia totalis (AT, total scalp hair loss) or alopecia universalis (AU, loss of all body hair). Persistent moderate-to-severe AA causes significant disfigurement and psychological distress in affected individuals (3). In clinical practice, there are no evidence-based treatments for AA (4), yet various treatments are offered, most commonly topical and intralesional steroids, which have limited efficacy.Our recent mechanistic studies demonstrated a dominant role for type I cellular immunity in AA pathogenesis, mediated by IFN-γ-producing NKG2D-bearing CD8 + cytotoxic T lymphocytes (CTLs) (5). The central role of type I cellular immunity is also reflected in the transcriptional landscape of AA lesional skin in humans and mice, which is dominated by IFN response genes and a CTL signature. These findings provided BACKGROUND. Alopecia areata (AA) is a common autoimmune disease with a lifetime risk of 1.7%; there are no FDA-approved treatments for AA. We previously identified a dominant IFN-γ transcriptional signature in cytotoxic T lymphocytes (CTLs) in human and mouse AA skin and showed that treatment with JAK inhibitors induced durable hair regrowth in mice by targeting this pathway. Here, we investigated the use of the oral JAK1/2 inhibitor ruxolitinib in the treatment of patients with moderate-to-severe AA.

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Section: L I N I C a L M E D I C I N Esupporting

confidence: 66%

Oral ruxolitinib induces hair regrowth in patients with moderate-to-severe alopecia areata

Mackay‐Wiggan¹,

Jabbari²,

Nguyen³

et al. 2016

JCI Insight

242

202

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“…Changes in clinical laboratory parameters, including neutrophil, lymphocyte and platelet counts, hemoglobin, creatine kinase, serum creatinine, and serum lipids (low-density lipoprotein and highdensity lipoprotein cholesterol), were generally stable during long-term treatment and reversible with appropriate medical management (78). In phase 2 and phase 3 studies of up to 52 wk of tofacitinib for patients with moderate to severe chronic plaque psoriasis (2,4,50,51,58), tofacitinib 5 mg bid and tofacitinib 10 mg bid have been well tolerated, with no new safety findings observed with respect to the RA program. In phase 2 studies of UC and CD (66,67), dose-dependent increases in low-density lipoprotein and high-density lipoprotein cholesterol levels were observed with tofacitinib, consistent with observations in tofacitinib RA and psoriasis studies; however, the UC and CD studies had relatively short durations and sample sizes.…”

Section: Jak Inhibition With Tofacitinibmentioning

confidence: 99%

JAK inhibition using tofacitinib for inflammatory bowel disease treatment: a hub for multiple inflammatory cytokines

Danese¹,

Grisham

Hodge

et al. 2016

American Journal of Physiology-Gastrointestinal and Liver Physi

150

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“…The efficacy of tofacitinib for the treatment of moderate to severe rheumatoid arthritis has been demonstrated in many studies (3)(4)(5)(6)(7)(8). Tofacitinib is also being developed for the treatment of other autoimmune disorders such as psoriasis (9) and inflammatory bowel disease (10).…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Effect of Tofacitinib Exposure on Outcomes in Kidney Transplant Patients

Vincenti

Silva

Busque

et al. 2015

American Journal of Transplantation

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Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo-controlled dose-ranging study

Abstract: Short-term treatment with oral tofacitinib results in significant clinical improvement in patients with moderate-to-severe plaque psoriasis and is generally well tolerated.

Cited by 297 publications

References 20 publications

Oral ruxolitinib induces hair regrowth in patients with moderate-to-severe alopecia areata

Oral ruxolitinib induces hair regrowth in patients with moderate-to-severe alopecia areata

JAK inhibition using tofacitinib for inflammatory bowel disease treatment: a hub for multiple inflammatory cytokines

Evaluation of the Effect of Tofacitinib Exposure on Outcomes in Kidney Transplant Patients

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