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Anti-TNF therapy in ankylosing spondylitis - Clinical and structural outcomes -. Dr. X. Baraliakos Rheumazentrum Ruhrgebiet, Herne Ruhr-University Bochum Germany. Ankylosing spondylitis: a chronic inflammatory rheumatic disease leading to high clinical impairment. 24 years.

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Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Anti-TNF therapy

in ankylosing spondylitis

- Clinical and structural outcomes -

Dr. X. Baraliakos

Rheumazentrum Ruhrgebiet, Herne

Ruhr-University Bochum

Germany


Ankylosing spondylitis a chronic inflammatory rheumatic disease leading to high clinical impairment

Ankylosing spondylitis: a chronic inflammatory rheumatic disease leading to high clinical impairment

24 years

  • Involvement of axial skeleton, entheses, perhipheral joints and other organs (e.g. eyes)

  • Main clinical symptom: inflammatory back pain

  • 1/3 of patients with severe clinical course

  • High prevalence (0.5%)

  • Strong association with HLA-B27

  • Late delay of diagnosis (5-7 years)

  • Decreased QoL

  • High risk of sick leave

  • Increased direct / indirect costs

AS

49 years

Braun J, Sieper J. Lancet 2007


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

InflammationdrivenbyTNFa in AS

Detection of TNF α mRNA in thebonemarrow of inflammedsacroiliacjoints

  • mRNABraun J et al.Arthritis Rheum 1995; 38: 499

  • proteinBraun J et al.Ann Rheum Dis 2000; 59S: 85

  • bone marrowFrancois R et al.Ann Rheum Dis 2005


Nsaids are efficacious in as

NSAIDs areefficaciousin AS

within 24 hours !

Amor B, et al. Rev Rheum Engl Ed 1995;62:10–5

Van der Heijde, et al. Arthritis Rheum 2005;52:1205–15


Many as patients are refractory to nsaids

Many AS patients are refractory to NSAIDs

% Patients

42%

29%

Clinical trials*n = 462

OASIS†n = 209

*Patients after 6 weeks of treatment with an active NSAID

†Epidemiological study = systematic recruitment of consecutive patients in daily practice


Disease activity in spa patients with inflammatory back pain with vs without peripheral arthritis

Sulfasalazine in early SpA

Disease activity in SpA patients with inflammatory back pain, with vs. without peripheral arthritis

BASDAI

BASDAI

IBP+, Peripheral arthritis -

IBP+, Peripheral arthritis +

IBP+, Peripheral arthritis -

p = 0.027

p = 0.3

IBP+, Peripheral arthritis +

at 6 months

at baseline

at 6 months

at baseline

Placebo (n = 118)

Sulfasalazine (n = 112)

Braun J, Baraliakos X et al. Ann Rheum Dis 2006 Sep;65(9):1147-53


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

ASAS/EULAR recommendations

for the management of AS

Education, exercise, physical therapy, rehabilitation, patient

associations, self help groups

NSAIDs

Ana

l

ges

i

cs

Peripheral disease

Axial

disease

Su

r

ge

r

y

Sulfasalazine

Local corticosteroids

TNF blockers

Zochling J et al. Ann Rheum Dis 2006 Apr;65(4):442-52


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

TNF Antagonists – a mile stone in the history of treatment of the (spondylo)arthritides

Physikalische und pharmakologische Eigenschaften


Anti tnf therapy in as clinical data

Anti-TNF therapy in AS- clinicaldata

Short-term data: Baseline - 6 months


The pilot study infliximab in as open continuation phase

The pilot study: infliximab in AS– open continuation phase

Infusions given according to disease activity (BASDAI)

Brandt J et al. Arthritis Rheum 2000; 43(6):1346


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Anti-TNF therapy in AS: Most patients achieve at least a 50% reduction of disease activity

2

6

12

weeks

Braun J et al. Lancet 2002; 359:1187-93


Significant improvement of function and spinal mobility

Significant improvement of function and spinal mobility

Braun J et al. Lancet 2002; 359:1187-93


Early experiences with etanercept in as

Early experiences with etanercept in AS

Improvement of disease activity (BASDAI)

n=30

ETN treatment in ETN group

ETN treatment in Placebo group

p = 0.003

Brandt J et al. Arthritis Rheum 2003; 48: 1667


Approval of etanercept for as

Approval of etanercept for AS

ASAS 20 Response Weeks 12 and 24

*P < 0.0001

Patients Responding (%)

Davis JC, Arthritis Rheum 2003; 8: 3230-3236


Etanercept treatment in as reduction of acute phase reactants

Etanercept treatment in ASReduction of acute phase reactants

Etanercept 2 x 25 mg/Wk (n=138)

Placebo (n=139)

BSG (mm/h)

Mittlere Änderung gegenüber dem Ausgangswert in %

Mittlere Änderung gegenüber dem Ausgangswert in %

CRP (mg/dl)

† p < 0,0001

† p < 0,0001

Week 2

Month 6

Month 3

Week 2

Month 6

Month 3

Davis JC, Arthritis Rheum 2003; 8: 3230-3236


Efficacy of adalimumab in patients with as the atlas trial

Efficacy of Adalimumab in patients with AS – The ATLAS Trial –

***

***

***

***

***

***

Week 24

Week 12

van der Heijde D, Arthritis Rheum, 2006. 54(7): 2136-2146

***Statistically significant at p<0.001 level (ANCOVA)


Asas 40 response at week 24 in trials of biologics for as

Adalimumab1

Etanercept2

*

Pbon=107

Ada 40 mg eown=208

Pbo n=139

Etan 25 mg BIWn=138

Infliximab

Golimumab

*

*

*

Pbon=78

Ifx 5 mg/kgn=201

Pbon=75

Glm 50 mgn=130

Glm 100 mgn=138

ASAS 40 Response at Week 24 in Trials of Biologics for AS

1van der Heijde D, et al. Arthritis Rheum. 2006;54:2136-2146;

2Davis JC, et al. Arthritis Rheum. 2003;48:3230-3236;

3van der Heijde D, et al. Arthritis Rheum. 2005;52:582-591.

* P <.001 vs placebo


Anti tnf therapy in as clinical data1

Anti-TNF therapy in AS- clinical data

Long-term follow-up: 6 months – 8 years


Patients with basdai 50 response after 3 years of infliximab treatment

Patients with BASDAI 50% Response after 3 years of infliximab treatment

Placebo-controlled phase

Open phase

Braun J, Rheumatology 2005. 44(5):670-6


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Continuous improvement of spinal mobility and function over 3 years

Placebo-controlled phase

Placebo controlled phase

Open phase

Open Phase

Mean BASMI

Mean BASFI

Braun J, Rheumatology 2005. 44(5):670-6


Anti tnf therapy in patients with as results after 8 years

Anti-TNFα therapy in patients with ASResults after 8 years

Infliximab

Baraliakos X, EULAR 2009, Copenhagen


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Anti-TNFα therapy in patients with ASResults after 6 years

Etanercept

Baraliakos X, EULAR 2009, Copenhagen


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Anti-TNFα therapy in patients with ASResults after 6 years

Etanercept

35.1%

33.3%

Baraliakos X, EULAR 2009, Copenhagen


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Efficacy of Adalimumab in patientswith AS – long-termdatafromthe ATLAS Trial

2 years

3 years

vd Heijde D et al, Ann Rheum Dis2008

vd. Heijde D, Arthritis Res Ther 2009, 11:R124


Golimumab asas partial remission after 104 weeks

Golimumab - ASAS Partial Remission after 104 weeks

Placebo/ Golimumab 50mg (n = 78)

Golimumab 50 mg(n = 138)

Golimumab 100 mg(n = 140)

GO-RAISE

Anteil Patienten (%)

Braun J. et al. ACR 2009, Abstract 1259

Braun J et al, ACR 2009, Abstract 1259


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Placebo/ Golimumab 50mg (n = 78)

Golimumab 50 mg(n = 138)

Golimumab 100 mg(n = 140)

GO-RAISE

Golimumab – ASAS 40 Response after 104 weeks

Anteil Patienten (%)

Braun J. et al. ACR 2009, Abstract 1259

Braun J et al, ACR 2009, Abstract 1259


Discontinuation of anti tnf treatment

Discontinuationof anti-TNF- treatment

Anti-TNF therapy in AS- clinical data


Design of studies

Design of studies

  • Withdrawal of biologic in all patients

  • Regular visits to assess clinical relapse

    (BASDAI > 4 and PhysGA > 4)

  • Retreatment with same dosis

  • Assessment of clinical parameters

ETN: Brandt J et al. Arthritis Rheum 2003; 48: 1667

Baraliakos X et al, Arthritis Rheum 2005 (53): 856-863

INF: Baraliakos X et al, Arthritis Res Ther 2005. 7(3): R439-44


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Clinically successful readministration of infliximab after withdrawal in all patients without infusion reactions

Infliximab withdrawal

Baraliakos X, Arthritis Res Ther 2005. 7(3): R439-44


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Clinically successful readministration of infliximab after withdrawal in all patients without infusion reactions

Infliximab withdrawal

Baraliakos X, Arthritis Res Ther 2005. 7(3): R439-44


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Clinically successful readministration of infliximab after withdrawal in all patients without infusion reactions

Infliximab withdrawal

Baraliakos X, Arthritis Res Ther 2005. 7(3): R439-44


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

BASDAI 50%, ASAS 40% response and partial remission after infliximab readministration

Infliximab withdrawal

after infliximab readministration

Baraliakos X, Arthritis Res Ther 2005. 7(3): R439-44


Duration of response after withdrawal

Duration of response after withdrawal

mean time to relapse: 17.5 ± 7.9 weeks

(range 7 – 45 wk, median 15 wk)


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Correlation between disease activity (BASDAI) and response to withdrawal

100%

100%

(p=0.039)

(p=0.039)

80%

80%

60%

60%

40%

40%

20%

20%

0%

0%

0

0

6

6

12

12

18

18

24

24

30

30

36

36

42

42

48

48

time to relapse (weeks)

time to relapse (weeks)

pts. with BASDAI < 3

pts. with BASDAI < 3

pts. with BASDAI >= 3

pts. with BASDAI >= 3

100%

(p=0.039)

80%

60%

40%

20%

0%

0

6

12

18

24

30

36

42

48

Kaplan-Meier Analysis

Log rank test

pts. with BASDAI < 3

pts. with BASDAI >= 3

Baraliakos X, Arthritis Res Ther 2005. 7(3): R439-44


Response to retreatment

Response to retreatment

  • Clear improvement of signs and symptoms

  • Disease status similar to before withdrawal

  • No adverse event, no other safety concern after resumption of etanercept and infliximab therapy

ETN: Brandt J et al. Rheumatology (Oxford). 2005 Mar;44(3):342-8.

Baraliakos X et al, Arthritis Rheum 2005 (53): 856-863

INF: Baraliakos X et al, Arthritis Res Ther 2005. 7(3): R439-44


Anti tnf therapy in as clinical data2

Anti-TNF therapy in AS- clinicaldata

Additional data


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Anti-TNFα in AS Patientswithtotal spinal ankylosis– Data fromthe ATLAS Trial –

  • Total spinal ankylosis (TSA) represents end-stage fusion of the spine in patients (pts) with ankylosing spondylitis (AS)

  • It is not uncommon for pts who already have TSA to still have symptoms of active disease.

vd Heijde et al, Ann Rheum Dis 2008;67:1218-1221


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Anti-TNFα in AS Patientswithtotal spinal ankylosis– Data fromthe ATLAS Trial –

  • Total spinal ankylosis (TSA) represents end-stage fusion of the spine in patients (pts) with ankylosing spondylitis (AS)

  • It is not uncommon for pts who already have TSA to still have symptoms of active disease.

vd Heijde et al, Ann Rheum Dis 2008;67:1218-1221


Etanercept 25mg week effective in some patients with active as

Etanercept25mg/week- effectivein somepatientswithactive AS

Berthelot J, Joint Bone Spine 74 (2007); 144-147

n = 21

n = 20


Improvement of key disease parameters by 3 mg kg infliximab

Improvement of key disease parameters by 3 mg/kg Infliximab

Maksymowych WP et al., J Rheumatol 2002; 29:959-65


Infliximab every 6 w vs on demand therapy response after 54 weeks continuous treatment is superior

Infliximab every 6 w. vs on demand therapy- response after 54 weeks:continuous treatment is superior

%

75%

46%

27%

7%

Breban M et al, Arthritis Rheum 2008 (58):88-97


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Addition of MTX to infliximab in patients with ankylosing spondylitis – response after 54 weeks:almost no difference

%

10%

40%

5%

51%

Breban M et al, Arthritis Rheum 2008 (58):88-97


Evidence for different types of response to anti tnf treatment in as

Evidence for different types of response to anti-TNF treatment in AS

Three groups of patients according to level and degree of

response after 5 years of infliximab treatment:

Group A: remission at most time points (> 20/25 visits)

Group B: low disease activity (BASDAI < 3) (> 20/25 visits)

Group C: limited improvement, not fulfilling ASAS 20 at all time points, BASDAI > 4 at some time points

Differences between groups:

mean age (< / > 40 yrs, mean disease duration (< / > 10 yrs,

mean BASFI at BL < / > 5)

Braun J, Baraliakos X et al, in press


Switching anti tnf therapy in spa

Switching anti-TNF therapy in SpA

infliximab toetanercept

  • patients with SpA n = 15

    • 11 female, 4 male, mean age 43

    • AS (n = 7)

    • uSpA (n = 6)

    • PsA (n = 2)

    • predominat axial involvement (n=13)

    • mean time of treatment with infliximab 11 months

  • inadequate response or loss of response (n=11)

  • side effects (n=5)

  • after 9 months 9/13 patients responded

Delaunay C et al. J Rheumatol 2005


Which as patients should be treated with tnf blockers

Which AS patientsshouldbetreatedwith TNF-blockers?


Asas consensus statement tnf blockers in ankylosing spondylitis

ASAS-Consensus Statement TNF-Blockers in ankylosing spondylitis

Diagnosis of AS

2 NSAIDs within3 m.

Non-respondersto

NSAIDs

Increaseddiseaseactivity

BASDAI > 4

+

Positive expert‘sopinion

Braun J, Ann Rheum Dis 2003, 62: 817-24

Braun J, Ann Rheum Dis 2006, 65: 201-8


Positive expert s opinion based on objective signs of inflammation

Positive expert‘sopinion:based on objectivesigns of inflammation

  • Clinical examination/Patient‘sclinicalhistory

  • Pos. CRP/ESR

  • Pos. MRI

  • Radiographicprogression


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

ASAS-Consensus Statement TNF-Blockers in ankylosing spondylitis

Start of therapywith TNF-blockers

Improvement after 3 months

BASDAI-Improvement> 50%

or

BASDAI-Improvement> 2 (0-10)

+

Pos. expert´sopition

Braun J, Ann Rheum Dis 2003, 62: 817-24

Braun J, Ann Rheum Dis 2006, 65: 201-8


Safety data infliximab

Safetydata– Infliximab –

Braun J, Baraliakos X et al, Ann Rheum Dis. 2008 March 1, 2008;67(3):340-5


Anti tnf therapy in as

Anti-TNF therapy in AS

Imaging


T cell infiltrates in sacroiliitis

T- Cell infiltrates in Sacroiliitis

Good Correlation of MRI with histology of SIJ biopsies in AS patients

Bollow M, Ann Rheum Dis 2000; 59(2):135-40


Infliximab in as 2 year mri results

Infliximab in AS – 2-year-MRI results

n=20

Sieper J, Baraliakos X et al. Rheumatology 2005


Spinal mri during etanercept therapy

Spinal MRI during etanercept therapy

improvement

T2-FS MRI sequence

worsening

Baraliakos X, Arthritis Rheum. 2005 Apr;52(4):1216-23


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

STIR MRI of the SIJ after 6 weeks and 24 weeks of etanercept treatment

at baseline

after 6 weeks

after 24 weeks

Rudwaleit M, Baraliakos X et al, Ann Rheum Dis. 2005 Sep;64(9):1305-10


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

The challenge in ankylosing spondylitis: less radiographic progression in continuous vs. on demand users of NSAIDs

n = 214

p < 0.02

Wanders A, Arthritis Rheum. 2005 Jun;52(6):1756-65


Radiographic spinal progression after 2 years of treatment with anti tnf

n.s.

n.s.

Etanercept1

Infliximab2

OASIS (all)

OASIS (all)

OASIS (matched)

OASIS (matched)

Adalimumab3

n.s.

OASIS (all)

OASIS (matched)

Radiographic spinal progression after 2 years of treatment with anti-TNF

Baseline characteristics TNF antagonists and OASIS (matched) are comparable

1van der Heijde et al. Arthritis Rheum 2008; 58: 1324-1331

2 van der Heijde et al. Arthritis Rheum 2008; 58: 3063-3070

3van der Heijde et al. ACR 2008 Abstract 670


Radiographic progression in as after 4 years treatment with the anti tnf a antibody infliximab

Radiographic progression in AS after 4 years treatment with the anti-TNF-a antibody infliximab

Baraliakos X et al, Rheumatology, 2007;46(9):1450-3


The long term radiographic progression in as

The long-term radiographic progression in AS

Linear mean radiographic progression

  • Retrospective

  • evaluation

  • FU = 13 years

  • n = 146

Baraliakos X et al, J Rheumatol 2009 May;36(5):997-1002


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Higher risk of radiographicprogressionwithsyndesmophytesatbaseline

after 2 years

Change in scoring units (mSASSS)

p <0.05

All patients (n=116)

Syndesmophytes at baseline (n=59)

No Syndesmophytes at baseline (n=59)

Baraliakos X, Ann Rheum Dis 2007 Jul;66(7):910-5


Anti tnf therapy in as1

Anti-TNF therapy in AS

Future perspectives


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Patients with spinal

lesions resolved

Sacroiliac

MRI lesions resolving

n=9 pts with BL spinal lesions

100

100

P=0.001

62.7%

60%

PBO (n=16)

NS

% of lesions resolving

% of patients

IFX (n=18)

50

50

29.4%

47/75

3/5

25%

20/68

1/4

0

0

100

Secondary endpoints

P=0.012

P=0.009

75

61.1

55.6

% of patients

50

18.8

25

12.5

0

ASAS50

partial remission

Efficacy of Infliximab in Patients

with HLA-B27+ Very Early AS

Diagnosis: Inflammatory back pain RCT: 16 weeks (n=40)

Primary endpoints: change in MRI scores from baseline to week 16

IFX (n=20)

New

sacroiliac MRI lesions

PBO (n=20)

100

P=0.004

% new lesions

50

12%

1.2%

0

Baseline values

Age (yrs)*: 28.8

Symptom duration (months)*: 15.3

% male pts: 75

% HLA-B27+ pts: 100

Barkham N, Arthritis Rheum 2009 Apr;60(4):946-54


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Adalimumab reduces SIJ inflammation

in active pre-radiographic active axial SpA

Baseline: 84% of patients with active sacroiliitis in MRI but no sacroiliitis on x-rays

RCT: 12 weeks (n=19)

OLE: 52 weeks (n=28)

p=0.004

p>0.05

p>0.05

p=0.003

Mean SI Joint Score (MRI)

ADA therapy significantly improved inflammation as observed by MRI for patients treated for 1 year

Haibel H. EULAR 2009 SAT0266


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Adalimumab reduces SIJ inflammation

in active pre-radiographic active axial SpA

Baseline

Week 12

Week 52

Haibel H. EULAR 2009 SAT0266


Anti tnf therapy in as2

Anti-TNF therapy in AS

Extraspinal manifestations


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Extra-articular Manifestations in AS Patients in Belgian Rheumatology Practices

A

S

P

E

C

T

n=847

58%

AS

22%

Uveitis

2%

6%

Psoriasis

1%

2%

1%

IBD

7%

Vander Cruyssen et al. Ann Rheum. Dis 2007; 66(8): 1072-7


Data collection

Data collection

Placebo-controlled studies

Infliximab (2 studies)

  • Braun J et al, Lancet, 2002 359 (9313): 1187-93

  • Van der Heijde et al, Arthritis Rheum, 2005 52(2): 582-91

    Etanercept (4 studies)

  • Gorman N et al, Engl J Med, 2002 346 (18): 1349-56

  • Brandt J et al, Arthritis Rheum, 2003 48 (6): 1667-75

  • Davis J et al, Arthritis Rheum, 2003 48 (11): 3230-6

  • Calin A et al, Ann Rheum Dis, 2004 63(12): 1594-600

    Adalimumab (2 studies)

  • van der Heijde D et al, . Arthritis Rheum 2006;54(7):2136-2146.

  • Haibel H, Arthritis Rheum 2006;54(2):678-681

    Open studies

  • Stone M et al, J Rheumatol, 2001 28(7): 1605-14

  • Gorman N et al, Engl J Med, 2002 346 (18): 1349-56

  • Braun J et al, Rheumatology (Oxford) 2005 44(5): 670-6

  • Baraliakos X et al, Arthritis Rheum, 2005 53(6): 856-63

  • Davis J et al, Ann Rheum Dis, 2005. 64(11): 1557-62

  • Braun J et al, Rheumatology (Oxford). 2005 May;44(5):670-6


Acute anterior uveitis in ankylosing spondylitis

Acute anterior uveitis in ankylosing spondylitis

  • Prevalence:30 - 40%

  • Incidence:10 - 20/100 patient years

  • Clinical presentation:acute, unilateral

  • Prognosis:generally good, some severe

  • Conventional Therapy:corticosteroid eye drops


Incidence of acute anterior uveitis in as patients on anti tnf therapy

Incidence of acute anterior uveitis in AS patients on anti-TNF therapy

n

/100 patient years

pooled data

n = 717

Braun J, Baraliakos X et al, Arthritis Rheum, 2005. 52(8):2447-51


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Incidence of anterior uveitis in AS- double-blinded and open-label phases

  • Infliximab:3.4 flares / 100 patient years (CI: 1.1 – 8.0)

  • Etanercept:7.9 flares / 100 patient years (CI: 5.5 – 11.1)

  • Placebo:15.6 flares / 100 patient years (CI: 7.8 – 27.9)

  • Statistical differences between incidences:

    • Placebo vs. anti-TNFα : p = 0.01

    • Placebo vs. Infliximab: p = 0.005

    • Placebo vs. Etanercept: p = 0.05

    • Infliximab vs. Etanercept: p = 0.08

Braun J, Baraliakos X et al, Arthritis Rheum, 2005. 52(8):2447-51


Inflammatory bowel diseases crohn s disease and ulcerative colitis in patients with as

Inflammatory bowel diseases (Crohn‘s disease and ulcerative colitis) in patients with AS

  • Prevalence:0.3 %

  • Incidence:10/100.000 / year

  • Clinical appearance:recurrences, flares, periphal symptoms

  • Prognosis:partly severe

  • Conventional Therapy:Corticosteroids, Azathioprine


Low but different incidence of acute inflammatory bowel disease ibd in patients on anti tnf therapy

Low but different incidence of acute inflammatory bowel disease (IBD) in patients on anti-TNF therapy

History of IBD in all patients 5.8 %

n

2.3/100py (14 cases)

2.3/100py (3 cases)

1.3/100py (2 cases)

0.2/100py

(1 case)

9 trials pooled data

n = 1130

py = patient years

n = 366

n = 434

n = 419

n = 295

INF vs. ETN p < 0.001, INF vs. ADA p = 0.02, ETN vs. ADA p = 1.0

Braun J, Baraliakos X et al, Arthritis Rheum. 2007 May 15;57(4):639-47


Summary

Summary

  • Treatment withbiologicsisefficaciousandsafe in thelong-term in patientswithactive AS

  • Improvement of clinical, laboratoryandimagingassessments of inflammationcanbeseenevenin patientswith total spinal ankylosis

  • Discontinuationleadstoclinicalrelapse but retreatmentissafeandefficacious


Summary1

Summary

  • DMARDs do not provideand additional benefit AS patientstreatedwithbiologics

  • Switchingbetweenbiologicsissafeandefficacious

  • Choice of biologiccompoundshouldbedonebased on individual needs of patient

  • Effect of biologictreatment on radiographicprogression of patientswith AS is still unclear


Dr x baraliakos rheumazentrum ruhrgebiet herne ruhr university bochum germany

Thank you !

Dr. X. Baraliakos

Rheumazentrum Ruhrgebiet, Herne

Ruhr-University Bochum

Germany


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