Effects of Biological Treatment on Blood Pressure and Endothelial Function in Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

• Etanercept (Drug): biological treatment according to rheumatologic indication
• Adalimumab (Drug): biological treatment according to rheumatologic indication
• Certolizumab (Drug): biological treatment according to rheumatologic indication
• Infliximab (Drug): biological treatment according to rheumatologic indication

Primary outcomes

• Change from baseline in blood pressure [prior to receiving anti-TNF-α treatment, 12 weeks]: Ambulatory Blood Pressure Monitoring (ABPM)

Secondary outcomes

• Change from baseline in endothelial function [prior to receiving anti-TNF-α treatment, 12 weeks]: Flow Mediated Dilatation / Endo Pat

Other outcomes

• Changes in immune cell subset populations from baseline [prior to receiving anti-TNF-α treatment, 12 weeks]: determination of subsets, activation markers, intracellular cytokine production

Sex: All, ages: 18 Years to any

Inclusion Criteria:

For patients suffering from rheumatoid arthritis:

* rheumatoid arthritis diagnosed based on The American Rheumatism Association Criteria from 1987
* ineffective treatment with 2 disease-modifying antirheumatic drugs (DMARDs) for 6 months each, including treatment with maximal doses of methotrexate for at least 3 months (or intolerance to treatment)
* high disease activity - Disease Activity Score 28 (DAS 28) > 5,1 measured twice, with a 1-month interval
* for patients with mainly lower limbs affected with DAS 28 > 3,7

For patients suffering from Ankylosing Spondylitis:

* Ankylosing Spondylitis diagnosed based on Modified New York Criteria
* ineffective treatment with 2 non-steroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months
* high disease activity -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) > 4 measured twice, with a 12-week interval
* spinal pain > 4cm on 10cm Visual Analogue Scale (VAS) measured twice, with a 12-week interval
* general disease activity assessment > 5 (0-10 scale) performed after the 2nd VAS and BASDAI assessment

For patients suffering from Psoriatic Arthritis:

\- Psoriatic arthritis diagnosed based on the Bennett or Classification Criteria for Psoriatic Arthritis (CASPAR Criteria)

If peripheral joints are affected:

active disease assessed twice, with a 4-week interval on stable treatment, after 2 DMARDs treatment for at least 4 months

Criteria of active disease (all have to be met):

* At least 5 out of 66 joints swollen - assessed twice, with a 4-week interval
* At least 5 out of 68 joints tender - assessed twice, with a 4-week interval
* general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by patient
* general disease activity assessment of 4 or 5 in the Likert scale (0- 5 scale) performed by physician
* general disease activity assessment > 5 (0-10 scale) performed after 2nd assessment of number of tender and swollen joints

If axial joints are affected:

* Sacroiliac joints affected according to the New York Criteria of Ankylosing Spondylitis
* Active and severe disease assessed twice, with a 12-week interval, stable treatment, ineffective treatment with 2 nonsteroidal anti-inflammatory drugs (administered separately) in maximal recommended or maximal tolerated dose for 3 months each

Criteria of active disease (all must be present):

* BASDAI > 4 measured twice, with a 12-week interval
* spinal pain > 4cm on 10 cm in the VAS measured twice, with a 12-week interval
* general disease activity assessment > 5 (0-10 scale) Patients can take steroid in stable dose within one month - maximal dose 10mg/day of prednisone.

Exclusion Criteria:

* non-consenting patient
* pregnancy
* breast-feeding
* allergy for the drug or any component
* cardiac insufficiency (NYHA III or IV)
* active infection
* infection within the last 3 months: hepatitis, pneumonia, pyelonephritis
* opportunistic infection within the last 2 months: active infection of cytomegalovirus, Pneumocystis carinii
* joint infection within the last 12 months
* endoprosthesis infection within the last 12 months or any time if the joint was not replaced
* exacerbation of lung-, kidney-, liver- or heart insufficiency during treatment
* demyelinating disease or its symptoms
* pancytopenia or aplastic anemia
* pre-cancer stage
* neoplasm within the last 5 years including solid tumors and neoplasm of haematopoietic or lymphatic system with risk of recurrence or progression
* active alcoholic disease
* chronic liver disease

• Tomasz Guzik, MD, PhD, Study chair, Jagiellonian University
• Bogdan Batko, MD, PhD, Study chair, Department of Rheumatology, J. Dietl Hospital, Krakow, Poland