NSAID refractory axial spondyloarthritis patients who are eligible after considering inclusion and exclusion crietria will be put on 5 mg tofacitinib BD ,at the end of 1st and 3rd month they will be assessed for safety and efficacy.Those who will not respond will be put on 10 mg tofacitinib BD.All patients will be assessed at the end of 6th month.If any adverse event occur they will be treated accordingly.

Axial Spondyloarthritis

The study subjects fulfilling the inclusion criteria will receive tofacitinib 5mg BD.
All the patients in the study group will go through disease history, clinical examination and baseline investigations. Baseline charachteristics and variables will be recorded at initiation of therapy, 4th, 12th and 24th week. Primary endpoint of efficacy will be assessed using ASAS 20 response at the end of 12 th wk. At the end of 12 th week, those patients will achieve primary endpoint will continue with the same dose and those patients who will not achieve primary endpoint will be put on tofacitinib10 mg BD. Those patients who will not respond to treatment at the end of 24 th wk will discontinue the therapy and put on alternative treatment.

Tofacitinib

Bangabandhu sheikh mujib medical university

Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial

ASAS 20:It is a composite measurement which means improvement of ≥ 20% in 3 of the following 4 domains without 20% worsening in the remaining domain
Four domains
Bath ankylosing spondylitis functional index(BASFI)-The 10 items index of daily functional activities completed on a numerical rating scale (NRS) 0-10. The higher the BASFI score, the more severe the limitation of function due to AxSpA
Morning stiffness
Patient global assessment
Pain

ASDAS-CRP: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1).

ASDAS-ESR: 0.113×patient global+0.293xESR−−−−√+0.086×peripheral pain/swelling+0.069×duration of morning stiffness+0.079×total back pain.

Dr.Md.Asadul Islam

Resident

Globe Pharmaceuticals Limited

Globe pharmaceuticals Ltd, Dhaka, Bangladesh

Eligible patients will be given tofacitinib 5 mg BD ,at the end of 1st and 3rd months they will be assessed for safety and efficacy.At 3rd months if any patient wll not responds then they will be given tofacitinib 10 mg BD,at the end of 6th month they will be assessed for safety and efficacy.If any adverse events occur they will be treated accordingly.

Healthy donors age and sex matched to the patients

Rheumatoid Arthritis

Patients that started DMARD therapy after the Baseline collection

Rheumatoid Arthritis With DMARDs

RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker

Rheumatoid Arthritis Baseline for TNF-blockers

RA patients recruited at least 6 months after the start of a TNF-blocker

Rheumatoid Arthritis With TNF-blockers

Ankylosing Spondylitis

Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration

Ankylosing Spondylitis Baseline for TNF Blocker

Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.

Ankylosing Spondylitis With TNF-blockers

Controls

Total

Sex: Female, Male

DAS28 for RA. 28 joints included. tender and swollen joint count (TEN28, SWO28). Erythrocyte sedimentation rate (ESR) is measured. The patient makes a subjective assessment (SA) of disease activity.
DAS28 ≤ 3.2 Inactive > 3.2 but ≤ 5.1 Moderate > 5.1 Very active
ASDAS for AS. Combines five disease activity variables in one single score
ASDAS
≤ 3.1Inactive > 3.1 but ≤ 2.1 Moderate > 2.1 but ≤ 3.5 Moderate > 3.5 Very active

Disease activity

ESR (mm/hr)

CRP (mg/dl)

Symptoms duration (years)

Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.

Osteoclast Differentiation Ex-vivo

Total area resorbed by osteoclasts as percentage of total area analyzed

Osteoclast Activity Ex-vivo

Overall Study

João Eurico Fonseca

Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.

spondylarthropathies/tyrosine

Safety and Efficacy of Tofacitinib in the Treatment of NSAID Refractory Axial Spondyloarthritis:A Clinical Trial

Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

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