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Review of the Outcome of the Treatment of NSAID-refractory Ankylosing Spondylitis (AS) with the Step-down Bridge Protocol of Intravenous and Oral Combination of 5 Immunosuppressants (SBP-5-IMNs)

Introduction
Myths are ingrained in the community that nothing can be done for patients with Ankylosing Spondylitis (AS). After the standard therapy with NSAIDs and physical therapy, the disease will run its natural course over 3-4 decades. NSAIDs neither stop or slow the progression of the disease in NSAID-refractory AS.

Drugs used in AS
Sulfasalazine shows only some variable beneficial effect in the peripheral joints in the short term. Methotrexate (MTX), pulse intravenous (IV) Methylprednisolone (MPS) and Cyclophosphamide (CyP), oral Cyclosporine (CyS) and Mycophenolate Mofetil (MMF) in single drug therapy show varying efficacy in the treatment of AS. However, combination therapy may be required when treating AS with MTX. No study has reported Remission in the treatment of AS.

The consequences are that myths are entrenched in the community, medical professionals, and rheumatologists

Myth No. 1 is Remission with whatever therapy is impossible in AS within months

Myth No. 2 is Remission by oral drugs is not possible in AS within months

Myth No. 3 is Remission without drug is unheard of in AS.

Myth No. 4 is healing of erosion(s) and termination of progression of calcification are
unheard of

Myth No. 1 is refuted by the SBP-5-IMNs with Remission achieved in 2-4 months

Myth No. 2 is refuted by the SBP-5-IMNs with Remission (RworalDs) achieved in
5.5-7.5 months

Myth No. 3 is refuted by the SBP-5-IMNs with Remission without Drug (RwD) achieved
In 53.5-55.5 months

Myth No. 4 is refuted by the SBP-5-IMNs with healing of erosion(s) and termination of
the progression of calcification

How are these outcomes achieved? Click

Clinical outcome
79 patients with NSAID-refractory AS treated with the SBP-5-IMNs in a 6 years observational study.

BASRI < 2: 87% of NSAID-refractory IMN-naïve AS independent of disease duration,
achieves Remission without Drug (RwD).

BASRI > 2: 64% of NSAID-refractory IMN-naïve AS independent of disease duration,
achieves Remission with oral Drugs (RworalDs)

8.0% not IMN-naïve NSAID-refractory AS patients, achieves improvement of ASAS70
15.2% are dropouts.

Radiological outcome after 6 years of the cases with
Baseline BASRI < 2 becomes BASRI 0 with healing of erosion and no new erosion
Baseline BASRI > 2 remains in status quo or not significantly worse compared with baseline with healing of erosion and new erosion prevented.

With the addition of intravenous 5-Fluorouracil (5FU), the SBP-5-IMNs becomes
SBP-6-IMNs. To suppress flare, the SBP-6-IMNs is more effective than the
SBP-5-IMNs, because of IMN-naivity of 5FU, but with similar adverse effects



AS Alert : do not let NSAID-refractory AS progress from BASRI < 2 to BASRI > 2, because RwD cannot be achieved by the SBP-6-IMNs.


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