Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: Long-term efficacy and safety results from 2 randomized phase-III studies and 1 open-label long-term extension study

Papp, Kim; Krueger, James G.; Feldman, Steven R.; Langley, Richard; Thaçi, Diamant; Torii, Hideshi; Tyring, Stephen K.; Wołk, Robert; Gardner, Annie; Mebus, Charles A.; Tan, Huaming; Luo, Yingchun; Gupta, Pankaj; Mallbris, Lotus; Tatulych, Svitlana

doi:10.1016/j.jaad.2016.01.013

Cited by 142 publications

(119 citation statements)

References 15 publications

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“…Safety data for tofacitinib is derived from large clinical trials in RA and psoriasis 42–45 , and data for ruxolitinib are from clinical trials in myelofibrosis and polycythemia vera 46–48 .…”

Section: Safety Datamentioning

confidence: 99%

“…Increases in total cholesterol, LDL cholesterol, and HDL cholesterol have been reported with tofacitinib and ruxolitinib therapy, but are typically mild 1,45,51,52 . Patients treated with JAK inhibitors do not appear to have an increased risk of major adverse cardiac events or stroke 42,45,53,54 .…”

Section: Safety Datamentioning

confidence: 99%

“…Patients treated with JAK inhibitors do not appear to have an increased risk of major adverse cardiac events or stroke 42,45,53,54 .…”

Section: Safety Datamentioning

confidence: 99%

“…IL-2R anatagonists, mycophenolate mofetil, and corticosteroids. An increased risk of lymphoproliferative disorders and other cancers has not been apparent when tofacitinib is used to treat inflammatory disorders such as RA and psoriasis 42,45,59,60 ; longer term studies, however, will more definitively answer this question. In patients with myelofibrosis and polycythemia vera treated with ruxolitinib, no increased risk of developing a second malignancy has been shown 61,62 .…”

Section: Safety Datamentioning

confidence: 99%

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JAK inhibitors in dermatology: The promise of a new drug class

Damsky

King

2017

Journal of the American Academy of Dermatology

396

286

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New molecularly targeted therapeutics are changing dermatologic therapy. JAK-STAT is an intracellular signaling pathway upon which many different pro-inflammatory signaling pathways converge. Numerous inflammatory dermatoses are driven by soluble inflammatory mediators which rely on JAK-STAT signaling, and inhibition of this pathway using JAK inhibitors may be a useful therapeutic strategy for these diseases. There is growing evidence that JAK inhibitors are efficacious in atopic dermatitis, alopecia areata, psoriasis, and vitiligo. Additional evidence suggests that JAK inhibition may be broadly useful in dermatology, with early reports of efficacy in several other conditions. JAK inhibitors can be administered orally or used topically and represent a promising new class of medications. The use of JAK inhibitors in dermatology is reviewed here.

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Section: Safety Datamentioning

confidence: 99%

Section: Safety Datamentioning

confidence: 99%

“…Patients treated with JAK inhibitors do not appear to have an increased risk of major adverse cardiac events or stroke 42,45,53,54 .…”

Section: Safety Datamentioning

confidence: 99%

Section: Safety Datamentioning

confidence: 99%

See 2 more Smart Citations

JAK inhibitors in dermatology: The promise of a new drug class

Damsky

King

2017

Journal of the American Academy of Dermatology

396

286

View full text Add to dashboard Cite

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“…The efficacy and safety of tofacitinib 5 and 10 mg twice daily (b.i.d.) in patients with moderate to severe chronic plaque psoriasis has been demonstrated in global phase 3 trials of up to 56 weeks’ duration, and in a long‐term extension (LTE) study with efficacy end‐points reported through 24 months and safety reported over 33 months of exposure . The efficacy and safety of tofacitinib has also been studied in several other immune‐mediated inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis (NCT01877668, NCT01882439, NCT01976364), ankylosing spondylitis, Crohn's disease (NCT01393626, NCT01393899, NCT01470599) and ulcerative colitis …”

Section: Introductionmentioning

confidence: 99%

Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized, placebo‐controlled phase 3 trial

Abe

Nishigori

Torii

et al. 2017

The Journal of Dermatology

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Tofacitinib is an oral Janus kinase inhibitor. These post‐hoc analyses assessed tofacitinib efficacy and safety in Japanese patients with psoriasis enrolled in a 52‐week global phase 3 study. Patients received tofacitinib 5 mg, tofacitinib 10 mg or placebo twice daily (b.i.d.); placebo‐treated patients advanced to tofacitinib at week 16. Primary efficacy end‐points were the proportions of patients with 75% or more reduction from baseline Psoriasis Area and Severity Index (PASI‐75) and Physician's Global Assessment (PGA) of “clear” or “almost clear” (PGA response) at week 16. Other end‐points included: Itch Severity Item (ISI), Dermatology Life Quality Index (DLQI) score and Nail Psoriasis Severity Index (NAPSI). Adverse events (AEs) were recorded throughout the study. Overall, 58 Japanese patients were included in this analysis (tofacitinib 5 mg b.i.d., n = 22; 10 mg b.i.d., n = 24; placebo, n = 12); 29 completed the study. At week 16, significantly more patients receiving tofacitinib 5 and 10 mg b.i.d. versus placebo achieved PASI‐75 (50% and 75% vs 0%, P < 0.01) and PGA response (59% and 75% vs 0%, P < 0.001). Substantial improvements in ISI, DLQI and NAPSI score were observed with both tofacitinib doses. Over 52 weeks, similar rates of AEs were reported across treatment groups; one serious AE occurred with tofacitinib 10 mg b.i.d. Herpes zoster occurred in three patients receiving tofacitinib 10 mg b.i.d. No deaths, serious infections, malignancies or gastrointestinal perforations were reported. Results were generally consistent with global analysis, suggesting sustained efficacy and a manageable safety profile, with increased herpes zoster incidence, of tofacitinib in Japanese patients with psoriasis.

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