Psoriasis
Conditions
Keywords
Psoriasis, Adalimumab, B vitamins, Homocysteine, Folic acid, Cyanocobalamin, Pyridoxine, Vitamin B6, Vitamin B9, Vitamin B12
Brief summary
Vitamins modulating homocysteine affect both TNF-alpha, vascular endothelial growth factor, and theoretically enhance the anti-inflammatory version of NOS thus hopefully increasing the efficacy and reducing the chance of some toxicities of adalimumab as determined by blood testing and EKGs.
Detailed description
This is a pilot study designed to evaluate whether addition of oral vitamin B12, vitamin B6, and folic acid to the use of adalimumab for psoriasis leads to further improvement of a patient's psoriasis and quality of life.
Interventions
DRUGHumira Then Humira plus 3 B vitamins
Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin
Sponsors
Abbott
Wayne State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults 18 or older * moderate to severe plaque psoriasis (\>10% BSA) * Negative pregnancy test within 7 days before first dose of adalimumab in all women (except surgically sterile or 5 years postmenopausal) * subject must sign/date appropriate written informed consent&HIPAA authorization * Sexually active subjects of childbearing potential must agree to use medically acceptable contraception during screening and throughout the study * no evidence of active or latent tuberculosis based on a negative PPD skin test performed at screening, or within one year of starting this study. Patients with documentation of adequately treated TB may be enrolled * Patients PPD positive and CXR negative can be enrolled if they finish appropriate INH prophylaxis prior to enrollment * be willing and able to self-administer subcutaneous injections or to have a qualified person available to administer these injections * agrees to comply with protocol requirements, attend all regularly study visits and is considered to be a good study subject * meets concomitant medication washout requirements * willing to use only allowed psoriasis medications and treatments and agree not to start any topical, systemic, or phototherapy for psoriasis during the study period * adalimumab naïve
Exclusion criteria
* erythrodermic, pustular, or guttate psoriasis * skin conditions other than psoriasis that would interfere with study-related psoriasis evaluations * known sensitivity to any component of the study medications * Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits * history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, OR oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline * positive PPD and positive chest x-ray for latent or active tuberculosis * positive PPD and negative chest x-ray that have not completed appropriate INH prophylaxis * On immune compromising drug or history of immune compromising disorder or immunodeficiency * poorly controlled medical condition including, not limited to, unstable cardiovascular disease, poorly controlled diabetes, recent stroke, history of recurrent infections, or any condition for which, in the opinion of the investigators, participation in the study would place the subject at risk * hx. congestive heart failure * hx. demyelinating CNS disease * History of malignancy (other than previously treated localized carcinoma in situ of the cervix or previously treated nonmelanoma skin cancer) * history of or ongoing drug or alcohol abuse * past or present psychiatric morbidity which may compromise the study * Pregnant women, nursing mothers, or planning to become pregnant during study or within 150 days after last dose of study medication. Males planning pregnancy with spouse/partner while in study are to be excluded * plans to receive any live vaccines during study * history of liver disease * Current enrollment in another clinical study/treatment with other experimental drug or approved therapy for experimental use within 30 days prior to Week 0 * previous enrollment in this study * cannot commit to all assessments required by the protocol * disorder that compromises the subject to give written informed consent and/or comply with study procedures * considered by the investigators to be unsuitable candidate * cannot comply with the protocol washout requirements * on folic acid in doses over than the minimal daily requirements * on vitamins higher than minimal daily requirements (multivitamins are allowed) * colon polyps or cancer * prior adalimumab therapy * on screening plasma Vascular Endothelial Growth Factor level is 140 pg/ml or more
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change | Weeks 16 and 28 | PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change | Week 16 and Week 28 | DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12). |
| Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl) | At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination | Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine | Week 16 and Week 28 | Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis.. |
| Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA): | Week 16 and Week 28 | Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28. |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level | At Week 16 and Week 28 | Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis. |
| Number of Participants With Category Change in Serum Folic Acid Level. | Weeks 16 and 28 | Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. |
| Number of Participants With Category Change in Vitamin B12 Blood Level | At Week 16 and Week 28 | Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Week 16 and Week 28 | Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12. |
| Number of Participants Within Categories of Body Temperature Change | Weeks 16 and 28 | Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. |
| Number of Participants in the Categories of Having and Not Having an Adverse Event | After Week 16 of study | Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study: AE Humira only |
| Number of Participants Within the Categories of Increasign and Decreasing Body Weight | Week 16 and Week 28 | Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study. |
| Number of Participants Who Fulfilled the Category of Having Height Measured | Week 0 at Start of Adalimumab | Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis. |
| Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) | By Week 16, by Week 28 and by Day 70 post Week 28. | A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28. |
| Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs) | Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination | An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study. |
| Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | Week 16 and Week 28 | Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis. |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium | Weeks 16 and 28 | Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis. |
| Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus | Week 16 then Week 28 | Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12. |
| Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody | Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins | Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study. |
| Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg) | At screening | Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study. |
Participant flow
Recruitment details
All subjects were recruited at one of the Two Wayne State University Physician Group Dermatology clinics . Recruitment began Oct 2010 and lasted until 2012
Pre-assignment details
There were 11 potential subjects analyzed of which 3 were not enrolled prior to study assignment. The 3 did not meet study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Humira Then Humira Plus 3 B Vitamins Humira then Humira plus 3 B vitamins
The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.
Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Humira Then Humira Plus 3 B Vitamins |
|---|---|
| Adult patients with plaque psoriasis >10% BSA Female | 3 participants |
| Adult patients with plaque psoriasis >10% BSA Male | 5 participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| number enrolled participants | 8 participants 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 7 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change
PASI: formula based on body surface areas on head/neck, trunk, both arms & legs with disease quality grading induration, scale and erythema on participants ages 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28.
Time frame: Weeks 16 and 28
Population: 8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had PASI measured at weeks 16 and 28. One had SAE prior to week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change | Improved | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change | Unchanged | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Particpants With a Categorical PASI (Psoriasis Area and Severity Index) Change | Worsened | 2 participants |
Secondary
Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA):
Number of participants with a category change in Physician static Global Assessment (sPGA): 7 point score from 0 (clear) to 6 measuring amount of surface covered and plaque qualities: thickness & erythema plus scaling. Dynamic score compares baseline with either improvement/ worsening of the same factors measured in the sPGA using the 0-6 scoring range but focused on change. sPGA at weeks 16 AND 28. dynamic PGA to be categoically measured at.weeks16 and 28.
Time frame: Week 16 and Week 28
Population: 8 adult participants with moderate to severe plaque psoriasis. 7 had static PGA scores weeks 16 and 28 and one had sPGA but SAE prior to week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA): | Improved | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA): | Unchanged | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With a Categorical Change in Static Physician Global Assessment (sPGA): | Worsened | 3 participants |
Secondary
Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change
DLQI is 10 questions examining impact of skin disease on quality of life: (1) symptoms & feelings (2) daily activities (3) leisure (4) work & school (5) personal relationship (6) treatment. To be administered to adults over 18 years with moderate to severe plaque psoriasis at week 0 (no systemic psoriasis medication);. weeks 16 ( after 16 weeks of adalimumab) and week 28 (after 16 weeks adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12).
Time frame: Week 16 and Week 28
Population: 8 adults with moderate to severe plaque psoriasis measured at weeks 16 and 28. Seven were measured weeks 16 and 28. One had SAE prior to week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change | Improved | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change | Unchanged | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With a Categorical DLQI (Dermatology Life Quality Index) Change | Worsened | 1 participants |
Secondary
Number of Participants With Category Change in Serum Folic Acid Level.
Serum folic acid level in adults ages 18 and older with mild to moderate plaque psoriasis measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab plus 12 weeks of adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
Time frame: Weeks 16 and 28
Population: 8 particpantts with psoriasis. Five had folic acid levels drawn weeks 16 and 28. Three did not (one of the 3 had a SAE prior to week 16).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum Folic Acid Level. | Increased | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum Folic Acid Level. | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum Folic Acid Level. | Decreased | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum Folic Acid Level. | Not evaluable (if >20 ng/ml only stated as such) | 2 participants |
Secondary
Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl)
Adult particpants ages 18 or older with moderate to severe plaque psoriasis were to have serum VEGF measured at week 0 on no systemic psoriasis medication then at both weeks 16 on adalimumab and at week 28 on adalimumab plus folic acid, B6 and Vitamin B12. Subjects raniked by BMI week 0 low to high
Time frame: At Screening visit, Week 16 on Humira, after another 12 weeks on Humira plus vitamins and if early termination
Population: 8 adult subjects age 18-65 with moderate to sefver plaque psoriasis. Five subjects had VEGF levels taken weeks 16 and 28. Three ( one wiht SAE prior to week 16) did not.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl) | Increased | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl) | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Serum VEGF (Vascular Endothelial Growth Factorl) | Decreased | 1 participants |
Secondary
Number of Participants With Category Change in Vitamin B12 Blood Level
Adult participants 18 years or older with moderate to severe plaque psoriasis were to have serum B12 levels measures Weeks 0 (on no systemic psoriasis medication), 16 (on adalimumab) and week 28 (on adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
Time frame: At Week 16 and Week 28
Population: 8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Five of 8 had B12 measured at weeks 16 and 28. Three did not. One of the 3 had SAE prior to week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Vitamin B12 Blood Level | Increased | 5 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Vitamin B12 Blood Level | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants With Category Change in Vitamin B12 Blood Level | Worsened | 0 participants |
Secondary
Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine
Serum homocysteine measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumaband then 12 weeks of adalimumab plus 5 mg folic acid, 100mg B6 and 1000 mcg of B12 in adults ages 18-65 with moderate to sever plaque psoriasis..
Time frame: Week 16 and Week 28
Population: 8 adults 18-65 with moderate to severe plaque psoriasis. 4 had levels measured at Week 16 and again at Week 28. Of the 4 not meausres 1 had a SAE prior to Week16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine | Increased | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Homocysteine | Decreased | 3 participants |
Secondary
Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level
Serum vitamin B6 levels were to be measured weeks16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab and 12 weeks on adalimuamb, folic acid 5 mg, b6 100 mg and B12 1000 mcg in adult participants with moderate to sever plque psoriasis.
Time frame: At Week 16 and Week 28
Population: 8 adults 18-65 with moderate to severe plaque psoriasis measured at weeks 16 and 28. .Four of 8 had levels drawn at weeks 16 and 28. Four did not. Of the four whoi did not one had a SAE prior to Week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level | Increased | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Vitamin B6 Level | Decreased | 0 participants |
Post Hoc
EKG Categoryy Changes Related to Homocysteine Changes
Change in EKG ( normalize, unchanged, became abnormal) when homocysteine (Hcy) increased or decreased from week 16 on adalimumab to week 28 on adalimumab plus folic acid, vitamins B6 and B12 in adault psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.
Time frame: Week 16 to Week 28
Population: 8 adults with moderate to severe plaque psoriasis ages 18-65. 4 were studied. Four were not because homocysteine levels at both Week16 nd 28 were not drawn(1 of the 4 had SAE prior to Week 16).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | EKG Categoryy Changes Related to Homocysteine Changes | normalize when Hcy increased | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | EKG Categoryy Changes Related to Homocysteine Changes | unchanged when Hcy decreased | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | EKG Categoryy Changes Related to Homocysteine Changes | became abnormal when Hcy decreased | 1 participants |
Other Pre-specified
Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count)
Change in CBC parameter: white blood count or hemoglobin or hematocrit ( as measured week 16 on adalimumab and at week 28 after 12 more weeks on adalimuamb , folic acid, B6 and B12) in adults ages 18-65 with moderate to severe plaque psoriasis.
Time frame: Week 16 and Week 28
Population: 8 adult participants with moderate to severe plaque psoriasis. Five had CBCs at both week 16 and week 28. three did not ( one of the 3 had a SAE pripor to week 16)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | WBC increased | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | WBC unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | WBC decreased | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | Hemoglobin/Hematocrit increased | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | Hemoglobin/Hematocrit unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in Categories or Increasing and Decreasing Changes Within the CBC (Complete Blood Count) | Hemoglobin/Hematocrit decreased | 2 participants |
Other Pre-specified
Number of Participants in the Categories of Having and Not Having an Adverse Event
Worsening psoriasis or development or worsening of measured condition or new pathology not seen by week 16 but developed at weeks 28 or first discoved by telephone call day 70 post study: AE Humira only
Time frame: After Week 16 of study
Population: 8 adult participants ages 18-65 with moderate to severe plaque psoriasis. Seven assessed after week 16 and at Week 28 of study and assessed at day 70 post week 28 visit ( the latter by telephone). One subject had SAE prior to vitamin addition.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and Not Having an Adverse Event | Adverse Event Weeks 16-28 | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and Not Having an Adverse Event | No Adverse Event after Week 16 | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and Not Having an Adverse Event | Adverse event by Day 70 call after Week 28 | 1 participants |
Other Pre-specified
Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE)
A serious adverse event is hosptalization or death or pathology leading to early termination of a participant from the study. This was to be reported at anytime during the 28 week study of adult patients ages 18-65 with moderate to severe plaque psoriasis though categorized by Week 16 (on adalimumab alone, by Week 28 (on adalimuamb plus 3 B vitaminsand by day 70 post Week 28.
Time frame: By Week 16, by Week 28 and by Day 70 post Week 28.
Population: Adults ages 18-65 with moderate to severe plaque psoriasis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) | No SAE | 7 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) | SAE by Week 16 | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) | SAE by Week 28 | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Having and of Not Having a Serious Adverse Event (SAE) | SAE by Day 70 afterWeek 28 | 0 participants |
Other Pre-specified
Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs)
An electrocardiogram (EKG) is used to evaluate the electrical activity of the heart by converting this activity into line tracings on paper.. Electrodes (small, plastic patches) are placed at certain locations on the chest, arms, and legs. When the electrodes are connected to an EKG machine by lead wires, the electrical activity of the heart is measured, interpreted, and printed out for the doctor's information and further interpretation. This test was to be administered to adults age 18 or older with moderate to severe plaque psoriasis patients at week 0, 16 and week 28 of this study.
Time frame: Week 16 and then Week 28 after another 12 weeks on Humira plus vitamins and if early termination
Population: 8 adults with moderate to severe plaque psoriasis. Seven evaluated at weeks 0,16 and 28 for no change in electrocardiogram (EKG) , worsening arrhymia or improvement of arrhythmia at weeks 16 and 28. Five of 8 studied weeks 0,16 and 28; 1 at week 16 and 28. Two (one with the SAE prior to Week 16) did not have EKGs both at weeks 16 and 28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs) | Normalizing | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs) | Unchanged | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants in the Categories of Normalizing, Unchanging and Newly Abnormal Electrocardiograms (EKGs) | Newly abnormal | 1 participants |
Other Pre-specified
Number of Participants Who Fulfilled the Category of Having Height Measured
Height is the distance from the bottom (soles of feet ) to the top (top of head) of a person when that person is standing in this study using ruler in inches.Participants measured were adults age 18 or older with moderate to severe plaque psoriasis.
Time frame: Week 0 at Start of Adalimumab
Population: 8 Adults with mild to moderate plaque psoriasis had their height measured at week 0 in inches.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Who Fulfilled the Category of Having Height Measured | Measured | 8 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Who Fulfilled the Category of Having Height Measured | Not measured | 0 participants |
Other Pre-specified
Number of Participants Within Categories of Body Temperature Change
Using a thermometer for body temperature on degrees Fahrenheit. Participants to be measured were adults 18 years or older with moderate to severe plaque psoriasis with temperature to be measured at week 16 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
Time frame: Weeks 16 and 28
Population: 8 Subjects. Five had temperatures measured weeks 16 and 28. Three did not (one of the 3 had SAE prior to week16)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within Categories of Body Temperature Change | increased | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within Categories of Body Temperature Change | unchanged | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within Categories of Body Temperature Change | decreased | 1 participants |
Other Pre-specified
Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody
Adult participants age 18 years or older with moderate to severe plaque psoriasis with serum IgG antibodies against Helicobacter pylori bacteria using commercial ELISA assay during the 28 week study.
Time frame: Week 28 after 16 weeks of Adalimumab then 12 of Adalimumab-Vitamins
Population: 8 adult participants with moderate to severe plaque psoriasis with H. pylori titers measured during the 28 week study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody | Elevated | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Elevated and Normal Helicobacter Pylori Antibody | Normal | 6 participants |
Other Pre-specified
Number of Participants Within the Categories of Increasign and Decreasing Body Weight
Weight is how heavy a participant is. Weight in pounds of each study adult participant age 18-65 years with moderate to severe plaque psoriasis measured at weeks 16 and compared to week 28 of study.
Time frame: Week 16 and Week 28
Population: 8 adults ages 18-65 with moderate to severe plaque psoriasis. Seven of 8 had weights taken weeks 0,4,16 and 28 allowing week16 and 28 analysis. One had weight taken only at weeks 0 and 4.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasign and Decreasing Body Weight | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasign and Decreasing Body Weight | Decreased | 5 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasign and Decreasing Body Weight | Increased | 2 participants |
Other Pre-specified
Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures:
Blood pressure is the force the heart exerts against the walls of arteries as it pumps the blood out to the body. The unit of measurement is millimeters of mercury (mm Hg). Pulse is the number of times your heart beats per minute. The unit of measurement is beats per minute (BPM). These test measurements compared in adults with moderate to severe plaque psoriasis week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg vitamin B12.
Time frame: Week 16 and Week 28
Population: of 8 adults with moderate to severe plaque psoriasis, Seven participants were measured at week 16 after 16 weeks adalimumab and at week 28 after 16 weeks adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12. One who had SAE prior to Week 16 did not..
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Systolic BP increased | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Systolic BP unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Systolic BP decreased | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Diastolic BP increased | 5 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Diastolic BP unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Diastolic BP decreased | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Pulse increased | 5 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Pulse unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Blood Pressure and Pulse Measures: | Pulse decreased | 2 participants |
Other Pre-specified
Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium
Serum magnesium (Mg) was to be measured at baseline, Week 16 (on adalimumab) and at week 28 (on adalimumab plus folic acid, vitamins B6 and B12) in adult participants age 18 or older with moderate to severe plaque psoriasis.
Time frame: Weeks 16 and 28
Population: 8 Adults age 18-65 with moderate to severe plaque psoriasis.Five had results both weeks 16 and 28. Three did npot (of these 1 had SAE prior to week 16)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium | Increased | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium | Unchanged | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Magnesium | Decreased | 2 participants |
Other Pre-specified
Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus
Serum phosphorus (P) levels were to be measured weeks16 and 28 in adult participants age 18 and older with moderate to severe plaque psoriasis at week 0 on no systemic psoriasis medication; week 16 after 16 weeks of adalimumab and at week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
Time frame: Week 16 then Week 28
Population: 8 adults 18-65 years having moderate to severe plaque psoriasis. Five had levels measured at week 16 and and again at week 28 . Three did not . Of the 3 1 had SAE prior to week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus | Increased | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus | Unchanged | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Increasing and Decreasing Serum Phosphorus | Decreased | 2 participants |
Other Pre-specified
Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg)
Women of childbearing years over age 18 with moderate to severe plaque psoriasis on no systemic therapy at week 0 of study.
Time frame: At screening
Population: Only 1 of the 8 subjects was a woman of childbearing years during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg) | Negative | 1 participant |
| Humira Then Humira Plus 3 B Vitamins | Number of Participants Within the Categories of Positive Urine Pregnancy Test (Urine Hcg) | Positive | 0 participant |
Post Hoc
PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF
Baseline VEGF level at week zero related to PASI change Week 16 on adalimumab compared to Week 28 after additonal 12 weeks of adalimumab plus folic acid, vitamin B6 and B12 in adult psoriasis patients ages 18-65 with moderate to severe plaque psoriasis.High levels were greater than or equal to 140 pg/ml. Normal VEGF was below this level.
Time frame: Week 16 and Week 28
Population: 8 adult participants with moderate to severe plaque psoriasis ages 18 to 65. Seven were analyzed. The one not analyzed had SAE prior to week16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF | PASI improved with high VEGF | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF | PASI Worsened with high VEGF | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF | PASI Unchanged with normal VEGF | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF | PASI Improved with normal VEGF | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change in Participants With Baseline VEGF Above 140 pg/ml and in Participants With Normal Baseline VEGF | PASI Worsened with normal VEGF | 0 participants |
Post Hoc
PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3
Change in PASI from Week 16 on adalimumab to Week 28 on adalimumab, folic acid, vitamin B6 and B12 in adults ages 18-65 with moderate to severe plaque psoriasis.
Time frame: Week 16 and Week 28
Population: 8 Adult subjects ages 18-65 with moderate to severe plaque psoriasis. 7 had PASI data both Week 16 and Week 28. The 1 who did not had SAE prior to Week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3 | BMI<27.3 who worsened | 2 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3 | BMI >27.3 who improved | 4 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3 | BMI<27.3 who improved | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3 | BMI >27.3 who worsened | 0 participants |
| Humira Then Humira Plus 3 B Vitamins | PASI Change Related to Baseline Body Mass Index Above, Below and Equal to 27.3 | BMI of 27.3 who were unchanged | 0 participants |
Post Hoc
Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers.
Change in PASI from Week 16 after 16 weeks of adalimumab to Week 28 after another 12 weeks of adalimumab plus folic acid, vitamins B6 and B12 and Change reported by telephone 70 days after week 28
Time frame: Week 16 to Week 28 and Week 28 to post study day 70
Population: 8 Adults ages 18-65 with moderate tosevere plaque psoriasis. 7 subjects studied. The 8th had SAE prior to Week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira Then Humira Plus 3 B Vitamins | Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers. | normal titer worsened | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers. | high titer worsened | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers. | high titer improved then worsened day 70 | 1 participants |
| Humira Then Humira Plus 3 B Vitamins | Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers. | normal titer improved | 3 participants |
| Humira Then Humira Plus 3 B Vitamins | Psoriasis Change in Participants With High H. Pylori Titers and With Normal Titers. | normal titer unchanged then improved day 70 | 1 participants |