Ankylosing spondylitis (referral & NSAID symptom control)

200 mg once daily (or 100 mg twice daily); may increase to 200 mg twice daily if symptoms persist

(Child >=2 years for juvenile idiopathic arthritis: 50 mg BID (10-25 kg) or 100 mg BID (>25 kg))

Sourced preference. The entry's own rationale names celecoxib first-line pharmacological therapy for inflammatory back pain, with naproxen kept for when cardiovascular risk argues against a coxib.

Celecoxib US prescribing information, Dosage and Administration (DailyMed SetID 2c86ece8-1cf5-4688-91b1-8aef5d60b7e4)

First-line pharmacological therapy for inflammatory back pain and stiffness in axial spondyloarthritis

500 mg twice daily with food continuously while inflammatory symptoms persist

Not recommended under 16 years for this indication - the product label restricts paediatric naproxen to juvenile idiopathic arthritis (10 mg/kg/day in two divided doses, child over 5 years). Use paracetamol or ibuprofen instead.

Naproxen 500 mg Tablets SmPC section 4.2 (eMC product 2639)

Non-selective NSAID alternative preferred when cardiovascular risk is a concern

60 mg once daily; may be increased to 90 mg once daily if 60 mg gives insufficient relief. The dose for ankylosing spondylitis must not exceed 90 mg daily - Use the lowest effective dose for the shortest time consistent with symptom control, and review the need to continue at every visit

Contraindicated in children and adolescents under 16 years of age.

eMC SmPC, Arcoxia 90 mg film-coated tablets (Organon), sections 4.1 and 4.2

67 live products - the second-largest orphan on the list after esomeprazole. Ankylosing spondylitis is a named SmPC indication with its own dose ceiling, and this condition had two free slots. A COX-2 inhibitor causes less gastroduodenal injury than the naproxen already listed, which matters when an NSAID is taken continuously for years.

Subcutaneous, one standard dose. SmPC verbatim: "The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection." - Reviewed at 12 weeks. SmPC verbatim: "Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period." The disease article sets the same clock: "the response to TNF-Is should be evaluated after 12 weeks."

Not a paediatric prescription in this disease. Humira's paediatric spondyloarthritis licence is enthesitis-related arthritis from 6 years, which is a different indication with its own weight-based dose - a child with inflammatory back pain goes to paediatric rheumatology, not onto an adult regimen.

The disease article names it first among the three TNF inhibitors it lists, and of the two Egypt registers it has the wider choice of products - nine adalimumab presentations against four etanercept. Etanercept beside it is a genuine alternative, and the cheaper one.

Humira 40 mg solution for injection in pre-filled pen SmPC sections 4.1, 4.2 and 4.4 (eMC product 7986)

The disease article names the step and the drug, verbatim: "If NSAIDs do not provide adequate relief, they can be combined with or substituted for tumor necrosis factor inhibitors (TNF-Is) such as adalimumab, infliximab, or etanercept." The SmPC's indication section names the disease, verbatim: "Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy." Rheumatology starts it; the card carried NSAIDs alone, which is the first half of the article's own sentence. Nine Egyptian adalimumab products are registered.

Subcutaneous. SmPC verbatim, for "Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis": "The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly." - Reviewed at 12 weeks. SmPC verbatim: "For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period."

Not a paediatric prescription in this disease. Enbrel's paediatric licences are juvenile idiopathic arthritis, adolescent psoriatic arthritis, enthesitis-related arthritis and paediatric plaque psoriasis; ankylosing spondylitis is written for adults.

Enbrel 50mg solution for injection in pre-filled syringe SmPC sections 4.1, 4.2 and 4.3 (eMC product 273)

The disease article names it, verbatim: "If NSAIDs do not provide adequate relief, they can be combined with or substituted for tumor necrosis factor inhibitors (TNF-Is) such as adalimumab, infliximab, or etanercept." The SmPC's indication section names the disease, verbatim: "Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy." Etanercept sits beside adalimumab as an equal option, which is how the article writes it. Egypt registers four products - ENBREL 25 mg and 50 mg, and the biosimilar ERELZI at roughly a third of the price.

Intravenous infusion, dosed by body weight. SmPC verbatim: "5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks." - Stopped early if the first two doses do nothing. SmPC verbatim: "If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with infliximab should be given." The disease article sets a longer clock for the class - "the response to TNF-Is should be evaluated after 12 weeks."

Not a paediatric prescription in this disease. SmPC verbatim: "The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established." A child with inflammatory back pain goes to paediatric rheumatology.

Remsima 100 mg powder for concentrate for solution for infusion (infliximab) SmPC sections 4.1, 4.2, 4.3 and 4.4 (eMC product 3709)

The disease article names the step and the drug, verbatim: "If NSAIDs do not provide adequate relief, they can be combined with or substituted for tumor necrosis factor inhibitors (TNF-Is) such as adalimumab, infliximab, or etanercept." The SmPC's indication section names the disease, verbatim: "Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy." It is the third of the article's three named TNF inhibitors and the only one the card lacked. Rheumatology starts it. Egypt registers one infliximab product, REMICADE 100 mg powder for intravenous infusion at roughly 5,900 EGP a vial, and a course is several vials per infusion at adult body weights.