Phase 3 Trials of Tirbanibulin Ointment for Actinic Keratosis

Blauvelt, Andrew; Kempers, Steven; Lain, Edward; Schlesinger, Todd; Tyring, Stephen K.; Forman, Seth; Ablon, Glynis; Martin, George M.; Wang, Hui; Cutler, David L.; Fang, June; Kwan, Min-Fun Rudolf

doi:10.1056/nejmoa2024040

Cited by 92 publications

(114 citation statements)

References 23 publications

Supporting

Mentioning

101

Contrasting

Unclassified

Order By: Relevance

“…Furthermore, partial clearance was observed in higher rates in the 5-day cohort (56% [95% CI = 45, 67]) than in the 3-day cohort (52% [95% CI = 41, 63]; Table 2). 1 11 Tirbanibulin exhibited higher complete clearance levels (44% in trial 1 and 54% in trial 2) than control ointment clearance levels (5% in trial 1 and 13% in trial 2), with P < 0.001 for both trials; 68% and 76% (P < 0.001) of patients achieved partial clearance (≥75% reduction in the number of lesions) in trials 1 and 2 when compared with the control group There were no serious AEs. AEs consisted of local skin reactions, with pain and pruritus at the site being the most common.…”

Section: Summary Of Phase 2 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 87%

“…In 47% of patients with complete clearance, lesions recurred at 1 year (Table 2). 11 The median percentage reduction in lesion count as compared with baseline was 83% in the tirbanibulin group and 20% in the vehicle group in trial 1, and 100% (tirbanibulin) and 25% (vehicle) in trial 2. The pooled median percentage reduction in the AK lesion count on day 57 was greater with tirbanibulin (87.5%) than with the vehicle (20%).…”

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 91%

“…The average age of patients was 70 years, with a range of 45 to 96 years. 8,10,11 Patients received a 5-day consecutive regimen of either tirbanibulin or the control ointment. They were assessed on day 57 for number of lesions.…”

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 99%

“…12 The median percentage reduction is a valuable metric because it is independent of the baseline number of lesions. 11 The majority of participants in the clinical trials were Caucasian (99%) men (87%) with Fitzpatrick skin types I or II (72%); therefore, differences in treatment outcomes among race and sex could not be clearly determined. 8,10 However, patients younger than 65 years of age and older than 65 years of age experienced similar outcomes when using tirbanibulin.…”

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 99%

“…None of the tirbanibulin-treated patients discontinued treatment for treatment-related adverse events out of 353 patients across 2 trials. 11 Adverse Events. The most common adverse effects of tirbanibulin are pruritus and pain at the application site and LSRs.…”

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 99%

See 4 more Smart Citations

1% Tirbanibulin Ointment for the Treatment of Actinic Keratoses

Dao

Sahni

et al. 2021

Ann Pharmacother

View full text Add to dashboard Cite

Objective Actinic keratoses (AKs) are cutaneous lesions that arise in sun-damaged skin. AKs may transform into squamous cell carcinoma in situ. Tirbanibulin 1% ointment is a new topical treatment for AKs, recently approved by the Food and Drug Administration. Data Sources The PubMed database was searched for articles published from 1960 to March 31, 2021, using the keywords tirbanibulin and Klisyri. Data Extraction Phase 2 and phase 3 clinical trials were reviewed. Data Synthesis In phase 2 clinical trials, 43% of patients treated with tirbanibulin experienced complete clearance by day 57 (43% [95% CI = 32, 54]). Across two phase 3 clinical trials (pooled data), complete (100%) clearance occurred in 49% of patients in tirbanibulin groups and in only 9% of the vehicle groups (difference, 41% points; 95% CI = 35 to 47; P < 0.001). Although no comparative studies are available, tirbanibulin is applied for a shorter duration (5 days) compared with diclofenac 3% gel, fluorouracil 5% cream, and imiquimod 3.75% cream. Adverse events were mild and included pruritus, application site pain, and local skin reactions. Systemic adverse events such as necrosis and angioedema, observed with other AK treatments such as fluorouracil and imiquimod, were not observed with tirbanibulin, thus giving tirbanibulin a favorable safety profile. Relevance to Patient Care and Clinical Practice Tirbanibulin effectively reduces AK burden and recurrence and has a favorable safety profile with mild adverse events. In comparison, imiquimod, 5-flourouracil, and diclofenac can result in necrosis, angioedema, and arthralgias. Conclusion With a favorable safety profile and short regimen, tirbanibulin is an efficacious treatment for clinicians to utilize in their treatment toolbox when treating AKs on the face and scalp.

show abstract

Section: Summary Of Phase 2 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 87%

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 91%

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 99%

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 99%

Section: Summary Of Phase 3 Clinical Trials For 1% Tirbanibulin Ointmentmentioning

confidence: 99%

See 3 more Smart Citations

1% Tirbanibulin Ointment for the Treatment of Actinic Keratoses

Dao

Sahni

et al. 2021

Ann Pharmacother

View full text Add to dashboard Cite

show abstract

Squamous Cell Carcinoma and its Precursors

Gupta,

Dirschka

2024

Rook's Textbook of Dermatology

View full text Add to dashboard Cite

Squamous cell carcinoma (SCC) is the second commonest skin cancer and arises from epidermal keratinocytes or its appendages. The incidence of SCC has increased over the last five decades and is predicted to rise significantly over the next decade. SCC is predominantly a disease of white populations and is especially prevalent in this group in areas of high ambient sun exposure. Predisposing factors include male sex, immune suppression (particularly in those who are organ transplant recipients), sun exposure and advanced age. Precursor lesions such as actinic keratosis and Bowen disease may often be present and patients are more susceptible to developing other UV radiation‐induced skin cancers. SCC has a low rate of metastasis but this increases with SCCs displaying high‐risk features. All SCCs should undergo full clinicopathological correlation and high‐risk SCCs should be managed within a multidisciplinary setting with adequate tumour clearance as the main outcome.

show abstract