Moderate to Severe Psoriasis
Conditions
Keywords
adalimumab therapy, Psoriasis, observational study
Brief summary
Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate * Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion criteria
* Participants should not be enrolled if they cannot be treated in accordance with the local product label * Participants enrolled into another study or clinical trial * History of hepatitis B infection * History of neurologic symptoms suggestive of central nervous system demyelinating disease * History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix) * Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment * Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method * Use of another anti-tumoral necrosis factor previously * History of congestive heart failure * Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk * Participants with active infection including chronic or localized infections until infections are controlled * History of sensitivity to latex * Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response | Baseline to Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model. |
| Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score | Baseline to Week 16 | Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Adalimumab Treatment | up to 16 weeks | Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment. |
| European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 | Baseline, Week 16 | EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2. |
| Mean Dermatology Life Quality Index (DLQI) Score Over Time | Baseline, Week 4, Week 8, Week 16 | DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model. |
| Mean Psoriasis Area and Severity Index (PASI) Score Over Time | Baseline, Week 4, Week 8, Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model. |
| Number of Participants With Serious Adverse Events (SAEs) | From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks). | An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy. |
Countries
Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Treatment in Participants With Psoriasis Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Family Reasons | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Adalimumab Treatment in Participants With Psoriasis |
|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 1 / 29 |
Outcome results
Primary
Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.
Time frame: Baseline to Week 16
Population: Participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score | 92 percentage of participants |
Primary
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.
Time frame: Baseline to Week 16
Population: Participants with available data. One participant was excluded from the analysis because only baseline and not follow-up information was available. Furthermore, 3 participants did not have their PASI measurement available either at baseline or at their last follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response | 78 percentage of participants |
Secondary
Adherence to Adalimumab Treatment
Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
Time frame: up to 16 weeks
Population: Participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | Adherence to Adalimumab Treatment | No Missed Doses | 24 participants |
| Adalimumab Treatment in Participants With Psoriasis | Adherence to Adalimumab Treatment | One Missed Dose | 3 participants |
| Adalimumab Treatment in Participants With Psoriasis | Adherence to Adalimumab Treatment | Two Missed Doses | 2 participants |
Secondary
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.
Time frame: Baseline, Week 16
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 | Baseline | 0.48 units on a scale | Standard Deviation 0.4 |
| Adalimumab Treatment in Participants With Psoriasis | European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 | Week 16 | 0.80 units on a scale | Standard Deviation 0.32 |
Secondary
Mean Dermatology Life Quality Index (DLQI) Score Over Time
DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.
Time frame: Baseline, Week 4, Week 8, Week 16
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | Mean Dermatology Life Quality Index (DLQI) Score Over Time | Baseline | 20.3 units on a scale | Standard Deviation 5.5 |
| Adalimumab Treatment in Participants With Psoriasis | Mean Dermatology Life Quality Index (DLQI) Score Over Time | Week 4 | 10.8 units on a scale | Standard Deviation 6 |
| Adalimumab Treatment in Participants With Psoriasis | Mean Dermatology Life Quality Index (DLQI) Score Over Time | Week 8 | 5.9 units on a scale | Standard Deviation 5.5 |
| Adalimumab Treatment in Participants With Psoriasis | Mean Dermatology Life Quality Index (DLQI) Score Over Time | Week 16 | 4.6 units on a scale | Standard Deviation 7.9 |
Secondary
Mean Psoriasis Area and Severity Index (PASI) Score Over Time
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.
Time frame: Baseline, Week 4, Week 8, Week 16
Population: Participants with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | Mean Psoriasis Area and Severity Index (PASI) Score Over Time | Baseline | 22.8 units on a scale | Standard Deviation 9 |
| Adalimumab Treatment in Participants With Psoriasis | Mean Psoriasis Area and Severity Index (PASI) Score Over Time | Week 4 | 10.6 units on a scale | Standard Deviation 9.8 |
| Adalimumab Treatment in Participants With Psoriasis | Mean Psoriasis Area and Severity Index (PASI) Score Over Time | Week 8 | 6.7 units on a scale | Standard Deviation 8.4 |
| Adalimumab Treatment in Participants With Psoriasis | Mean Psoriasis Area and Severity Index (PASI) Score Over Time | Week 16 | 4.2 units on a scale | Standard Deviation 9.1 |
Secondary
Number of Participants With Serious Adverse Events (SAEs)
An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.
Time frame: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
Population: Participants who received at least one dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adalimumab Treatment in Participants With Psoriasis | Number of Participants With Serious Adverse Events (SAEs) | 1 participants |