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Ritlecitinib kliniske
studier

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Tab Number 5

A total of 1630 patients, 12 years and older, received ritlecitinib in clinical studies representing 2303 patient-years of exposure1‐6
  • Multiple dose strengths of ritlecitinib were evaluated across all clinical studies
  • 3 placebo-controlled studies in alopecia areata were integrated to evaluate ritlecitinib vs placebo for up to 24 weeks
  • Additional studies with ritlecitinib included a long-term study in patients with alopecia areata and a study in patients with another disease
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Study Description
Phase 2a Study* Placebo-controlled in alopecia areata
ALLEGRO-2a† Placebo-controlled in alopecia areata
ALLEGRO-2b/3‡ Placebo-controlled in alopecia areata
ALLEGRO-LT§ No placebo control; long-term, open-label study in alopecia areata
Phase 2b‖ Placebo-controlled in another disease
ReferencesThe Phase 2a study was a randomised, double-blind, placebo-controlled, parallel-group, multicentre study that evaluated the efficacy and safety of ritlecitinib in adults ≥18 years of age with 50% or more scalp hair loss due to alopecia areata.The ALLEGRO-2a study was a randomised, double-blind, placebo-controlled study that evaluated the safety and tolerability of ritlecitinib in adults 18 to ≤50 years of age with 25% or more scalp hair loss due to alopecia areata. The ALLEGRO-2a study lasted for 60 months, 24 months of which were placebo-controlled. The data set for the placebo-controlled pool for alopecia areata utilised Weeks 0-24.The efficacy and safety of ritlecitinib were evaluated in a randomised, double-blind, placebo-controlled, phase 2b/3 pivotal study in patients 12 years and older with alopecia areata and 50% or more scalp hair loss. Patients were randomised to receive ritlecitinib or placebo. ALLEGRO-2b/3 is also known as AA-1.The ALLEGRO-LT study is an open-label, phase 3 study investigating the long-term safety and efficacy of ritlecitinib in adults and adolescents (12 years and older) with alopecia areata, including de novo patients defined as those who did not previously receive ritlecitinib, and patients who rolled over from the ALLEGRO-2a and ALLEGRO-2b/3 placebo-controlled studies.The efficacy and safety of oral ritlecitinib was evaluated in a randomised, double-blind, placebo-controlled, dose-ranging, phase 2b clinical study in patients 18 to 65 years old with another disease. See additional safety considerations Ytterligere sikkerhetsinformasjonLoading

The ALLEGRO-LT study is an open-label, phase 3 study investigating the long-term safety and efficacy of ritlecitinib in adults and adolescents (12 years and older) with alopecia areata, including de novo patients defined as those who did not previously receive ritlecitinib, and patients who rolled over from the ALLEGRO-2a and ALLEGRO-2b/3 placebo-controlled studies.

References:1. LITFULO (ritlecitinib) Summary of Product Characteristics. 2. King B, Guttman-Yassky E, Peeva E, et al. A phase 2a randomised, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results. J Am Acad Dermatol. 2021;85(2):379-387. doi:10.1016/j.jaad.2021.03.050 3. Placebo-controlled safety study of ritlecitinib (PF-06651600) in adults with alopecia areata. ClinicalTrials.gov identifier: NCT04517864. Updated July 27, 2023. Accessed September 26, 2023. https://clinicaltrials.gov/ct2/show/NCT04517864 4. King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. Lancet. 2023;401(10387):1518-1529. doi:10.1016/S0140-6736(23)00222-2. Erratum in: Lancet. 2023 Jun 10;401(10392):1928. 5. Long-term PF-06651600 for the treatment of alopecia areata (ALLEGRO-LT). ClinicalTrials.gov identifier: NCT04006457. Updated September 18, 2023. Accessed September 26, 2023. https://clinicaltrials.gov/ct2/show/NCT04006457 6. Ezzedine K, Peeva E, Yamaguchi Y, et al. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: a randomised phase 2b clinical trial. J Am Acad Dermatol. 2023;88(2):395-403. doi:10.1016/j.jaad.2022.11.005
PP-LGF-NOR-0019 | Utarbeidet 08.2024
Adverse reactions from 3 pooled placebo-controlled ritlecitinib studies in alopecia areata1
  • Patients received LITFULO 50 mg (n=130) and placebo (n=213) for 24 weeks
  • Adverse reactions are classified by system organ and frequency in order of decreasing seriousness using the following categories
    • Very common (≥1/10)
    • Common (≥1/100 to <1/10)
    • Uncommon (≥1/1000 to <1/100)
    • Rare (≥1/10000 to <1/1000)
    • Very rare (<1/10000)
System organ class common  Uncommon 
Infections and infestations
  • Herpes zoster
  • Folliculitis
  • Upper respiratory tract infections
  
Nervous system disorders
  • Dizziness
  
Gastrointestinal disorders
  • Diarrhoea
  
Skin and subcutaneous tissue disorder
  • Acne
  • Urticaria
  • Rash
  
Investigations
  • Blood creatine phosphokinase increased
  • Platelet count decreased
  • Lymphocyte count decreased
  • Alanine aminotransferase increased >3 x ULN*
  • Aspartate asminotransferase increased >3 x ULN*
*Includes changes detected during laboratory monitoring. Limitations & Biases
  • Adverse reaction rates observed in clinical trials may not fully characterise the risks of LITFULO
  • Certain adverse events may require longer observation periods and long-term patient exposure to ascertain risk
  • Safety analyses were based on observed data with no imputation of missing data. All analyses were ad hoc and there was no adjustment for multiplicity
 See additional safety considerations Additional safety considerations LoadingULN=upper limit of normal.References:1. LITFULO (ritlecitinib) Summary of Product Characteristics.

     
PP-LGF-NOR-0019 | Utarbeidet 08.2024
Specific adverse reactions reported in LITFULO clinical studies

 Overall
Infections

Herpes zoster

Opportunistic
Infections

Malignancy

Thromboembolic Events

Overall Infections

In the ALLEGRO-2b/3 study for up to 48 weeks

  • Overall infections were reported in 51% of patients (89.32 per 100 patient-years) who received LITFULO 50 mg or higher
In 3 placebo-controlled studies in alopecia areata for up to 24 weeks
  • Overall infections were reported in 33% of patients (74.53 per 100 patient-years) who received LITFULO 50 mg and 31% of patients (80.35 per 100 patient-years) with placebo
In the integrated safety analysis of 5 ritlecitinib clinical studies
  • Overall infections were reported in 45.4% of patients (50.02 per 100 patient-years) who received LITFULO 50 mg or higher
Serious Infections

In the ALLEGRO-2b/3 study and for up to 48 weeks
  • Serious infections were reported in 0.8% of patients (0.86 per 100 patient-years) who received LITFULO 50 mg or higher
In 3 placebo-controlled studies for up to 24 weeks
  • No serious infections were reported in patients who received LITFULO 50 mg or placebo
  • The proportion and rate of serious infections in patients who received LITFULO 200/50 mg were 0.9% (2.66 per 100 patient-years)
In the integrated safety analysis of 5 ritlecitinib clinical studies
  • Serious infections were reported in 0.8% (0.59 per 100 patient-years) in patients who received LITFULO 50 mg or higher
  • The most frequently reported serious infections were appendicitis, COVID-19 infection (including pneumonia), and sepsis

In the ALLEGRO-2b/3 study for up to 48 weeks

  • Herpes zoster was reported in 2.3% of patients (2.61 per 100 patient-years) who received LITFULO 50 mg or higher

In 3 placebo-controlled studies in alopecia areata for up to 24 weeks

  • Herpes zoster was reported in 1.5% of patients who received LITFULO 50 mg vs 0 patients who received placebo
  • Among patients who received ritlecitinib 200/50 mg (200 mg once daily for 4 weeks followed by 50 mg once daily), 1 patient experienced an event of varicella zoster virus infection that met criteria as an opportunistic infection (multi-dermatomal herpes zoster)

In the integrated safety analysis of 5 ritlecitinib clinical studies

  • The rate of herpes zoster infection was 1.1 per 100 patient-years in patients who received LITFULO 50 mg or higher
In the ALLEGRO-2b/3 study for up to 48 weeks
  • No patients who received ritlecitinib reported opportunistic infections of multi-dermatomal herpes zoster
In the 3 placebo-controlled studies in alopecia areata for up to 24 weeks
  • Opportunistic infections of multi-dermatomal herpes zoster were reported in 1 patient (0.5 per 100 patient-years) who received ritlecitinib 200/50 mg
In the integrated safety analysis of 5 ritlecitinib clinical studies
  • Opportunistic infections of multi-dermatomal herpes zoster were reported in 2 patients (0.09 per 100 patient-years) who received ritlecitinib 50 mg or higher

Malignancies, including NMSC, have been reported in patients who received ritlecitinib and other JAK inhibitors

  • It is not known whether selective JAK3 inhibition may be associated with adverse reactions involving JAK1 and JAK2
  • In a large, randomised, active-controlled study of tofacitinib (another JAK inhibitor) in patients with rheumatoid arthritis (RA) who were ≥50 years of age and had at least one additional cardiovascular risk factor, a higher rate of malignancies, particularly lung cancer, lymphoma, and NMSC was observed vs tumour necrosis factor (TNF) inhibitors
  • Limited clinical data are available to assess the potential relationship of exposure to ritlecitinib and the development of malignancies. Long-term safety evaluations are ongoing
  • The risks and benefits of LITFULO treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than a successfully treated NMSC or cervical cancer
  • Periodic skin examination is recommended for patients who are at an increased risk of skin cancer

Events of venous and arterial thromboembolism, including MACE, have been reported in patients who received ritlecitinib and other JAK inhibitors

  • It is not known whether selective JAK3 inhibition may be associated with adverse reactions involving JAK1 and JAK2
  • In a large, randomised, active-controlled study of tofacitinib (another JAK inhibitor) in patients with RA who were ≥50 years of age and had at least one additional cardiovascular risk factor, a higher rate of MACE, defined as cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, and a dose-dependent higher rate of venous thromboembolism, including DVT and PE, were observed with tofacitinib vs TNF inhibitors
  • Long-term safety evaluations for ritlecitinib are ongoing. LITFULO should be used with caution in patients with known risk factors for thromboembolism
  • In patients with a suspected thromboembolic event, discontinuation of LITFULO and prompt reevaluation is recommended. The risks and benefits of LITFULO treatment should be considered prior to initiating therapy in patients

Example

See additional safety considerations Additional safety considerations Loading

JAK=Janus kinase; NMSC-nonmelanoma skin cancer. WITH DVT=deep vein thrombosis;  MACE=major adverse cardiovascular events; PE=pulmonary embolism; RA=rheumatoid arthritis; TNF=tumour necrosis factor.

Reference:LITFULO (ritlecitinib) Summary of Product Characteristics.

       
PP-LGF-NOR-0019 | Utarbeidet 08.2024
Lab abnormalities observed in LITFULO clinical trials
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Decreased lymphocyte count
ALC <0.5 x 103/mm3 		In the integrated safety analysis of all 5 ritlecitinib clinical studies
  • ALC <0.5 x 103/mm3 occurred in 2 patients (<0.1%) who received LITFULO 50 mg
  • Maximum effect on ALC was observed within 4 weeks, after which ALC remained stable at a lower level with continued therapy
Decreased platelet count
<100 x 103/mm3 		In the ALLEGRO-2b/3 study for up to 48 weeks and placebo-controlled studies in alopecia areata for up to 24 weeks
  • LITFULO was associated with a decrease in platelet counts
  • Maximum effect on platelets was observed within 4 weeks, after which platelet count remained stable at a lower level with continued therapy

In the integrated safety analysis of all 5 ritlecitinib clinical studies
  • 1 (<0.1%) patient who received LITFULO 50 mg or higher had a confirmed platelet count<100 x 103/mm3
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Elevated CPK In the ALLEGRO-2b/3 for up to 48 weeks
  • CPK increase was reported in 3.8% of patients who received LITFULO 50 mg or higher
  • CPK elevation >5 x ULN was reported in 2 (0.9%) patients treated with placebo and 5 (3.9%) patients who received LITFULO 50 mg
  • CPK elevation >5 ULN was reported in 6.6% of patients who received LITFULO 50 mg or higher

In 3 placebo-controlled studies in alopecia areata for up to 24 weeks
  • CPK increase was reported in 2 (1.5%) patients who received LITFULO 50 mg
Increased transaminases
>3 ULN
In 3 placebo-controlled studies in alopecia areata for up to 24 weeks
  • Events of increases in ALT and AST values were reported in 3 patients (0.9%) who received LITFULO 50 mg and 2 patients (0.6%) who received ritlecitinib ≥50 mg
  • Most ALT and AST elevations were transient, and none led to discontinuation
See additional safety considerations Ytterligere sikkerhetsinformasjonLoading

ALC=absolute lymphocyte count; ALT=alanine aminotransferase; AST=aspartate aminotransferase; CPK=creatine phosphokinase; ULN=upper limit of normal.

Reference:LITFULO (ritlecitinib) Summary of Product Characteristics.

    
PP-LGF-NOR-0019 | Utarbeidet 08.2024
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