Trial Outcomes & Findings for Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis) (NCT NCT03885089)

Results Overview

An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

30 weeks from the day of initial dose

Results posted on

2025-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Overall Study No informed consent for publication of study results	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=8 Participants Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	0 Participants n=8 Participants
Age, Customized ≥15 and <65 years	5 Participants n=8 Participants
Age, Customized ≥65 years	3 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=8 Participants

PRIMARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The safety analysis set (8 participants) comprised of participants who satisfied the inclusion criteria and had received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\]. Participants with no informed consent for publication of study results were excluded.

An adverse drug reaction (ADR) was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=8 Participants Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions	2 Participants

SECONDARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI75 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available.

Percentage of participants with a PASI75 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 75% improvement were calculated as PASI75.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=3 Participants Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response	0.0 Percentage of Participants Interval 0.0 to 70.76

SECONDARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, percentage of participants with a PASI90 response as of the study completion date was calculated for the 3 participants whose PASI scores both at baseline and study completion date were available.

Percentage of participants with a PASI90 response was presented along with the two-sided 95% confidence interval (exact method). The PASI quantifies the severity of lesions and the percentage of lesion area. It is the total score of the degree of erythema, infiltration/thickening, and scaling (evaluated for each skin finding) in each of the 4 body regions evaluated by the physician. The score was adjusted for the percentage of lesion area of skin rash in each body region and the percentage of the area of each body region to the whole body. The percent change (%) in PASI score from baseline to the study completion date was calculated for each participant, and the number and proportion of participants with ≥ 90% improvement were calculated as PASI90.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=3 Participants Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response	0.0 Percentage of Participants Interval 0.0 to 70.76

SECONDARY outcome

Timeframe: 30 weeks from the day of initial dose

Population: The efficacy analysis set (4 participants) comprised of participants in the safety analysis set who had effectiveness evaluation. Of the 4 participants, summary statistics and change from baseline in BSA as of the study completion date was calculated for the 1 participant whose BSA both at baseline and study completion date were available.

Summary statistics of the BSA at baseline, at study completion date, and the change in BSA from baseline to study completion date was presented. BSA was calculated from the percentage of skin rash to body surface area from baseline to study completion date, and change in severity of disease was evaluated.

Outcome measures

Outcome measures
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=1 Participants Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Change From Baseline in Body Surface Area Involvement (BSA) At baseline	0.00 Percentage of BSA Standard Deviation NA The standard deviation was not available due to the small number of participants whose BSA was calculated.
Change From Baseline in Body Surface Area Involvement (BSA) At study completion date	30.00 Percentage of BSA Standard Deviation NA The standard deviation was not available due to the small number of participants whose BSA was calculated.
Change From Baseline in Body Surface Area Involvement (BSA) Change	30.00 Percentage of BSA Standard Deviation NA The standard deviation was not available due to the small number of participants whose BSA was calculated.

Adverse Events

Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3]

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar 3] n=8 participants at risk Participants with psoriasis vulgaris, psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis who received Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] as indicated in the approved local product document for the first time were observed for 30 weeks from the day of initial dose of this drug. The dosage can be adjusted as per physician's discretion.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both events during the study.
Nervous system disorders Headache	12.5% 1/8 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both events during the study.
Skin and subcutaneous tissue disorders Drug eruption	12.5% 1/8 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both events during the study.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both events during the study.
Skin and subcutaneous tissue disorders Psoriasis	12.5% 1/8 • 30 weeks from the day of initial dose The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER