Effect of tofacitinib withdrawal and re‐treatment on patient‐reported outcomes: results from a Phase 3 study in patients with moderate to severe chronic plaque psoriasis

Griffiths, C.E.M.; Vender, Ronald; Sofen, Howard; Kircik, Leon; Tan, Huaming; Rottinghaus, Scott T.; Bachinsky, Mary; Mallbris, Lotus; Mamolo, Carla

doi:10.1111/jdv.13808

Cited by 25 publications

(18 citation statements)

References 33 publications

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“…In sum, this study indicated that tofacitinib could be efficacious after withdrawal and retreatment. 30,31 OPT Compare was a randomized, placebo-controlled, 12 week, non-inferiority phase III trial comparing tofacitinib 5 mg and 10 mg to high dose entanercept or placebo in patients with moderate-to-severe plaque psoriasis. The primary endpoints were the proportion of patients with a PASI75 and the proportion of patients with a PGA response at 12 weeks of treatment.…”

Section: Psoriasis Clinical Trialsmentioning

confidence: 99%

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

Ly¹,

Beck²,

Smith³

et al. 2019

PTT

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Tofacitinib is an oral Janus kinase inhibitor approved for the treatment of psoriatic arthritis (PsA). It provides an alternative option for patients who have had an inadequate response and tolerance to other disease modifying antirheumatic drugs (DMARDs). It has demonstrated comparable efficacy to biologics, is effective in the management of treatment resistant disease, and is reported to improve enthesitis, dactylitis, and radiographic progression. Tofacitinib is also associated with an increased risk of serious infections, malignancy, and laboratory abnormalities. There is currently a large armamentarium of therapies for psoriatic arthritis, and choosing among treatments can be challenging. Due to this wide selection, a thorough assessment of psoriatic disease phenotype, patient preference, disease presentation, and comorbidities is critical. This review addresses key considerations in patient selection for the treatment of PsA with tofacitinib.

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Section: Psoriasis Clinical Trialsmentioning

confidence: 99%

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

Ly¹,

Beck²,

Smith³

et al. 2019

PTT

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“…The combination of tofacitinib 5 mg, BID with MTX, as approved for the treatment of RA, could also be a future option in the management of plaque psoriasis, especially if associated with PsA. In the Pivotal Retreatment study no rebound phenomena have been experienced [18], however it is not fully clear if tofacitninib can produce rebound phenomena upon withdrawal as reported for CsA. Similar to CsA the effect on T cell suppression is strong but rapidly reversible.…”

Section: Expert-commentary/discussionmentioning

confidence: 99%

Tofacitinib for the treatment of psoriasis and psoriatic arthritis

Berekméri

Mahmood

Wittmann

et al. 2018

Expert Review of Clinical Immunology

103

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Psoriasis and psoriatic arthritis (PsA) are inflammatory immune-mediated conditions which can cause considerable disability and reduced quality of life. Management can be complex as clinical heterogeneity may lead to different treatment pathways. Tofacitinib is a novel, oral Janus Kinase (JAK) inhibitor with proven efficacy in rheumatoid arthritis. Areas covered: This review analyzes recent studies of tofacitinib in psoriatic disease treatment. The relevant literature was identified using clinicaltrials.gov, PubMed, and Google Scholar. Tofacitinib efficacy was demonstrated in PsA by the OPAL Broaden and OPAL Beyond phase-III studies, and received FDA and EMA approval. Tofacitinib was superior to placebo for the treatment of moderate-to-severe plaque psoriasis in the OPT Pivotal 1 and 2, OPT Retreatment studies, but FDA approval was declined for this indication based on issues of clinical efficacy and long-term safety. Expert commentary: Tofacitinib is an important oral drug for the treatment of PsA. However, the long-term safety data require further evaluation. Tofacitinib and other JAK inhibitors show potential to broaden the treatment options in PsA and other inflammatory conditions.

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“…The efficacy of tofacitinib in reducing pruritus based on ISI score in patients with psoriasis has previously been reported (34)(35)(36). Placebo-adjusted mean decreases from baseline ISI scores surpassed the CID determined in this analysis (1.48), at ≤ 2 weeks with both tofacitinib doses in OPT Pivotal 1 (-1.48 at Day 13 and -1.55 at Day 6 for tofacitinib 5 and 10 mg BID, respectively), and with tofacitinib 10 mg BID in OPT Pivotal 2 (-1.56 at Day 11) and OPT Compare (-1.57 at Day 9), indicating clinically relevant improvements in pruritus with tofacitinib.…”

Section: Clinically Meaningful Improvements In Itch Severity Item Scomentioning

confidence: 99%

“…The efficacy and safety of tofacitinib has also been studied in several immunemediated inflammatory diseases, including rheumatoid arthritis (16)(17)(18)(19)(20)(21), psoriatic arthritis (22)(23)(24), ankylosing spondylitis (25), Crohn's disease (26)(27)(28), and ulcerative colitis (29,30). Moreover, the impact of tofacitinib on pruritus has previously been reported in Phase 2 studies of tofacitinib as a topical treatment for atopic dermatitis (31) and psoriasis (32), and Phase 2 and 3 studies of tofacitinib as an oral treatment for psoriasis (33)(34)(35)(36).…”

mentioning

confidence: 99%

“…The Itch Severity Item (ISI) is an 11-point numeric rating scale (NRS) that was used to assess the severity of pruritus in the Phase 3 clinical trials of tofacitinib for the treatment of patients with moderate to severe chronic plaque psoriasis (34)(35)(36). Other Itch NRSs have been validated for use in patients with chronic pruritus (41) and patients with moderate to severe plaque psoriasis (42).…”

mentioning

confidence: 99%

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Validation of the Itch Severity Item as a Measurement Tool for Pruritus in Patients with Psoriasis: Results from a Phase 3 Tofacitinib Program

Ständer¹,

Luger²,

Cappelleri

et al. 2018

Acta Derm Venerol

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Tofacitinib is an oral Janus kinase inhibitor. This post-hoc analysis aimed to investigate the psychometric properties of the Itch Severity Item (ISI), a numeric rating scale from 0 (no itching) to 10 (worst possible itching) for pruritus in psoriasis, and review the effect of tofacitinib on pruritus in patients with psoriasis participating in Phase 3 studies (N = 3,641). The ISI showed high test-retest reliability (intra-class correlation coefficient: 0.84). The clinically important difference was defined as a 1.48-point change, using Patient Global Assessment as an anchor. Mean changes from baseline in ISI scores with tofacitinib were significantly greater than placebo by Day 2 and exceeded the clinically important difference by Week 4 and Week 2 for tofacitinib 5 and 10 mg twice daily, respectively. The sound psychometric properties of the ISI as an assessment tool for pruritus in psoriasis were confirmed. Tofacitinib provided clinically meaningful improvements in psoriatic pruritus versus placebo.

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Effect of tofacitinib withdrawal and re‐treatment on patient‐reported outcomes: results from a Phase 3 study in patients with moderate to severe chronic plaque psoriasis

Cited by 25 publications

References 33 publications

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

<p>Tofacitinib in the management of active psoriatic arthritis: patient selection and perspectives</p>

Tofacitinib for the treatment of psoriasis and psoriatic arthritis

Validation of the Itch Severity Item as a Measurement Tool for Pruritus in Patients with Psoriasis: Results from a Phase 3 Tofacitinib Program

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