Guidelines
for

Medical Treatment
of

Rheumatoid Arthritis
Prof. Fathy Mohamed EL-Belasy (MD)
Prof. of Internal Medicine &...
Medical Treatment of RA
Prof. Fathy El-Belasy

Rheumatoid Arthritis
An autoimmune disease characterized by
symmetric erosi...
Medical Treatment of RA
Prof. Fathy El-Belasy

Rheumatoid Arthritis
Smoking has recently been recognized as a
critical fac...
Medical Treatment of RA
Prof. Fathy El-Belasy

Rheumatoid Arthritis
Some clinicians considered RA
as a cancer of the synov...
I

General Principles
Medical Treatment of RA
Prof. Fathy El-Belasy

I-General Principles

1-The ultimate aim of the treatment for any disease i...
Medical Treatment of RA
Prof. Fathy El-Belasy

I-General Principles

Low

disease

activity

means:

relief

of

symptoms,...
Medical Treatment of RA
Prof. Fathy El-Belasy

I-General Principles

Early diagnosis, Early referral to a
specialist, Earl...
Medical Treatment of RA
Prof. Fathy El-Belasy

I-General Principles

So early diagnosis, early referral to a
specialist an...
Medical Treatment of RA
Prof. Fathy El-Belasy

I-General Principles

3-Majority of patients are seen by
non-specialists wh...
I-General Principles

Medical Treatment of RA
Prof. Fathy El-Belasy

4- NSAIDs:

Are Symptom Modifying Anti Rheumatic
Drug...
Leflunomide & MTX (one month) till the onset of its effect

while SSZ & HCQ (3-6 month),GCs (hours).
I-General Principles

5-Patient’s assessment

Medical Treatment of RA
Prof. Fathy El-Belasy
I-General Principles

Medical Treatment of RA
Prof. Fathy El-Belasy

(A) Disease Activity

Disease activity is assessed du...
I-General Principles

Medical Treatment of RA
Prof. Fathy El-Belasy

(B) High resolution musculoskeletal ultrasonography

...
I-General Principles
(C) Laboratory investigations

• CBC

• HCV Ab

• Liver

• HB sAg

profile
• Renal
profile
• FBS

• C...
II

Recommendations for
management of RA
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

The patient has to be appropriatel...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(1) Methotrexate monotherapy

In c...
Medical Treatment of RA
Prof. Fathy El-Belasy

II-Recommendations for management of RA

(1) Methotrexate monotherapy
MTX

...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(2) Methotrexate + Synthetic DMARD...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Tailor treatment according to dise...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Glucocorticoids (GCs)

GCs is adde...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Glucocorticoids (GCs) (cont.)

GCs...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Glucocorticoids (GCs) (cont.)

GCs...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

According to disease activity
(iv)...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(3) Methotrexate + Biologics

I.

...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Poor prognostic factors:

(i) Fema...
Medical Treatment of RA
Prof. Fathy El-Belasy

II-Recommendations for management of RA

Despite of the ongoing discussion,...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If biological DMARDs + MTX is cons...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If biological DMARDs + MTX is cons...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If biological DMARDs + MTX is cons...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If biological DMARDs + MTX is cons...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If biological DMARDs + MTX is cons...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If biological DMARDs + MTX is cons...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

MTX is included in all combination...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

N.B: TNF is responsible for system...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(4) If the treatment target is not...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(4) If the treatment target is not...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(4) If the treatment target is not...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

(4) If the treatment target is not...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

In cases of refractory severe RA w...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If a patient with long standing (s...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

If a patient with long standing (s...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Biological DMARDs characteristics
...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Biological DMARDs characteristics
...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Biological DMARDs characteristics
...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Biologic DMARDs: Precautions & Con...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Biologic DMARDs: Precautions & Con...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Comorbidities
• Osteoporosis due t...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Tofacitinib (Xelijanz)

The U.S. F...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Tofacitinib (Xelijanz)
It may be u...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Tofacitinib (Xelijanz)

In April 2...
II-Recommendations for management of RA

Medical Treatment of RA
Prof. Fathy El-Belasy

Tofacitinib (Xelijanz)

These safe...
Conclusion
There is a great need for a new more effective
and less toxic drug which completely cure the

disease.

However...
Rheumatoid Arthritis Medical Treatment ( Prof. Fathy EL-Belasy) Strategy & Drugs
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Rheumatoid Arthritis Medical Treatment ( Prof. Fathy EL-Belasy) Strategy & Drugs

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Approach to Medical treatment of Rheumatoid Arthritis.
pharmacological treatment

by Prof. Fathy EL-Belasy

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Rheumatoid Arthritis Medical Treatment ( Prof. Fathy EL-Belasy) Strategy & Drugs

  1. 1. Guidelines for Medical Treatment of Rheumatoid Arthritis Prof. Fathy Mohamed EL-Belasy (MD) Prof. of Internal Medicine & Rheumatology Faculty of Medicine Alexandria University
  2. 2. Medical Treatment of RA Prof. Fathy El-Belasy Rheumatoid Arthritis An autoimmune disease characterized by symmetric erosive synovitis & sometimes multisystem involvement. It affects approximately 1% of the world’s population who are genetically predisposed. Most patients exhibit a chronic fluctuating course; if left untreated results in progressive joint destruction, deformity, disability & premature death.
  3. 3. Medical Treatment of RA Prof. Fathy El-Belasy Rheumatoid Arthritis Smoking has recently been recognized as a critical factor for the development of RF-positive RA, for the production of ACPA & is associated with more severe disease & reduced response to therapy. As such smoking cessation should be an essential part of treatment of Rheumatoid patients.
  4. 4. Medical Treatment of RA Prof. Fathy El-Belasy Rheumatoid Arthritis Some clinicians considered RA as a cancer of the synovial tissue which proliferates in an uncontrolled fashion (pannus)  erosions of the surrounding bone, cartilage and damage of tendons & ligaments leading to irreversible joint destruction and deformity.
  5. 5. I General Principles
  6. 6. Medical Treatment of RA Prof. Fathy El-Belasy I-General Principles 1-The ultimate aim of the treatment for any disease is to achieve a cure. In RA there is no cure; so the treatment target is either remission in early cases or low disease activity in long standing RA patients.
  7. 7. Medical Treatment of RA Prof. Fathy El-Belasy I-General Principles Low disease activity means: relief of symptoms, preservation of function and prevention of structural damage & deformity. Treatment must continue as in cases of DM or HTN. Discontinuation of treatment even in cases of remission  Rebound flare.
  8. 8. Medical Treatment of RA Prof. Fathy El-Belasy I-General Principles Early diagnosis, Early referral to a specialist, Early aggressive therapy 2- The concept of early initiation of more aggressive therapy is important because irreversible joint damage develops within the first 3 month after disease onset.
  9. 9. Medical Treatment of RA Prof. Fathy El-Belasy I-General Principles So early diagnosis, early referral to a specialist and early aggressive therapy (tight control) (window of opportunity, i.e. within the first 3 month of diagnosis), will delay or prevent the risk of bone erosions, joint destruction, deformity; which may improve patient’s survival and increase the number of years that patients enjoy a better quality of life.
  10. 10. Medical Treatment of RA Prof. Fathy El-Belasy I-General Principles 3-Majority of patients are seen by non-specialists who may not be aware about the emergency situation; so patients are seen 1-2 years after onset of the disease. Early referral to a specialist is of utmost importance.
  11. 11. I-General Principles Medical Treatment of RA Prof. Fathy El-Belasy 4- NSAIDs: Are Symptom Modifying Anti Rheumatic Drugs (SMARDs) i.e. do not stop the progress of the disease, so used during the bridge stage because DMARDs has no analgesic effect. So NSAIDs are used till the onset of the effect of DMARDs.
  12. 12. Leflunomide & MTX (one month) till the onset of its effect while SSZ & HCQ (3-6 month),GCs (hours).
  13. 13. I-General Principles 5-Patient’s assessment Medical Treatment of RA Prof. Fathy El-Belasy
  14. 14. I-General Principles Medical Treatment of RA Prof. Fathy El-Belasy (A) Disease Activity Disease activity is assessed during each clinical visit by: • Duration of morning stiffness. • Number of tender or swollen joints. • CRP. • Fatigue Drug failure is considered after 3-6 month drug trial.
  15. 15. I-General Principles Medical Treatment of RA Prof. Fathy El-Belasy (B) High resolution musculoskeletal ultrasonography Along with disease activity assessment to evaluate the success of DMARDs or Biologic therapy because it shows synovitis or early erosions.
  16. 16. I-General Principles (C) Laboratory investigations • CBC • HCV Ab • Liver • HB sAg profile • Renal profile • FBS • CRP • ACPA • RF Medical Treatment of RA Prof. Fathy El-Belasy
  17. 17. II Recommendations for management of RA
  18. 18. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy The patient has to be appropriately informed about • The disease itself. • Treatment options (DMARDs or Biologics) must be a shared rheumatologists. decision between patient and
  19. 19. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (1) Methotrexate monotherapy In cases of DMARDs naïve patients Methotrexate should be initiated as first line mono-therapy {with/without Glucocorticoids} at the maximally tolerated dose (7.5-25mg & rarely 30mg/week). (7.5- 20 PO & switch to SC or IM if the dose >20mg/week).
  20. 20. Medical Treatment of RA Prof. Fathy El-Belasy II-Recommendations for management of RA (1) Methotrexate monotherapy MTX is the most effective, safe (ease of administration, low cost and of long term therapy (515ys). It is first line agent & the anchor drug for combination therapy with other DMARDs & Biologic agents. Do not forget to add 1mg folic acid/day to guard against GIT, hematologic or pulmonary side effects.
  21. 21. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (2) Methotrexate + Synthetic DMARDs 2-Patients present who with inspite continue active to disease of MTX monotherapy, addition of another conventional DMARD is combined with MTX in a step up combination therapy.
  22. 22. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Tailor treatment according to disease activity (i) MTX + HCQ. (ii) MTX + SSZ. (iii) MTX + Leflunomide. Most experts no longer use loading dose if combined with MTX because of increased liver toxicity while HCQ minimize hepatic toxicity of MTX & lower LDL & T.G (iv) MTX + one or two or 3 DMARDs ± short term GCs. combination of these drugs with different modes of action allows the use of lower (individual) drug doses thus minimizing toxicity without reducing efficacy.
  23. 23. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Glucocorticoids (GCs) GCs is added at low to moderately high doses to Synthetic or Biologic DMARDs whether monotherapy or in combination. Morning 8-10am low dose <10mg/d gives a rapid relief of symptoms because it behaves as: • Anti cytokines (Anti IL-1,IL-2, Anti TNF ) • Anti COX NSAID effect • Anti LOX So they have actions equivalent to Anticytokines DMARDs, NSAIDs As well as inhibit lymphocyte proliferation & antigen presentation.
  24. 24. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Glucocorticoids (GCs) (cont.) GCs has a disease modifying effect without harmful side effects especially if used with Ca & Vit D in a dose <10mg (7.5mg/d) But more rapid improvement may be achieved by addition of GCs at a higher dose in cases of visceral involvement, e.g. pericarditis, pleurisy, fever, vasculitis)for a short term Ask for bone mineral density (BMD) DEXA scan during follow up.
  25. 25. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Glucocorticoids (GCs) (cont.) GCs minipulse therapy: During exacerbation of the disease GCs are used in a dose of 200-250mg IM or IV for 3 successive days, then go back to maintenance low dose This minipulse is equivalent to 1000mg/d pulse therapy in SLE No prolonged suppression of hypothalamic pituitary adrenal axis (HPA); so it has no adverse effect like that of long term use of GCs.
  26. 26. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy According to disease activity (iv) MTX + one or two or 3 DMARDs ± short term GCs. combination of these drugs with different modes of action allows the use of lower (individual) drug doses thus minimizing toxicity without reducing efficacy.
  27. 27. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (3) Methotrexate + Biologics I. If the treatment target is not achieved (remission/low disease activity) with MTX + two or more synthetic DMARDs ± short term GCs after 3-6 month. II. Or in cases of High Disease Activity (HDA) and poor prognostic factors; addition of biologic therapy should be considered from the start.
  28. 28. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Poor prognostic factors: (i) Female patient (ii) Smoker (iii) Old age (iv) Positive family history (v) High ESR or CRP (vi)High titer of ACPA (Anti CCP) or RF (vii)Early joint erosion at disease onset. (viii)Extra-articular manifestations (SC ulcers, PN) (ix)Worse physical function. (x) Poly-articular initial presentation. nodules or
  29. 29. Medical Treatment of RA Prof. Fathy El-Belasy II-Recommendations for management of RA Despite of the ongoing discussion, at the moment there is not enough evidence to support generalized use of biologic in association with MTX as first line therapy by doing so, we would be over treating at least 15-40% of patients who would respond to DMARDs. MTX mono-therapy or MTX +
  30. 30. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If biological DMARDs + MTX is considered start with 1st generation anti TNFα When Anti TNF α and Methotrexate is combined remission rate doubles.
  31. 31. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If biological DMARDs + MTX is considered start with 1st generation anti TNFα (i)Etanercept (ENBREL) (Totally humanized) 50mg SC/week.
  32. 32. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If biological DMARDs + MTX is considered start with 1st generation anti TNFα (ii)Adalimumab (HUMIRA) (Totally humanized) 40 mg SC/2 weeks.
  33. 33. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If biological DMARDs + MTX is considered start with 1st generation anti TNFα (iii)Infliximab (REMICADE): Chimeric monoclonal Ab (mouse 25% & human 75%) 3mg/kg slow IV infusion (2hrs) 0,2 W, 6 W 2 month.
  34. 34. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If biological DMARDs + MTX is considered start with 1st generation anti TNFα (iv)Golimumab (SIMPONI): Totally humanized 50mg SC/month.
  35. 35. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If biological DMARDs + MTX is considered start with 1st generation anti TNFα (v)Certolizumab Pegol (CIMZIA) (S.C) totally humanized 400mg at 0,2,4 weeks & then 200mg/2 weeks.
  36. 36. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy MTX is included in all combination therapy: -Combination between MTX + biologic therapy provides great benefit in improving signs & symptoms of RA; preventing radiographic destruction & improving physical functions in comparison to MTX or biologic monotherapy. -No combination of two biologic therapy because of high rate of adverse effects & lack of any additive effect
  37. 37. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy N.B: TNF is responsible for systemic manifestations: 1. Fever. 2. Anemia. 3. Cachexia. 4. Depression. 5. Endocrine effect of cytokines. 6. Joint inflammation.
  38. 38. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (4) If the treatment target is not achieved (remission/low disease activity) with MTX + 1st generation anti TNF , go to 2nd generation Biological drugs. (i)Abatacept (selective co-stimulation modulator). Dose according to body weight (10mg/kg):
  39. 39. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (4) If the treatment target is not achieved (remission/low disease activity) with MTX + 1st generation anti TNF , go to 2nd generation Biological drugs. (i)Abatacept (ORENCIA) (selective co-stimulation modulator) FDA approved in August 2011 subcutaneous formulation of Abatacept. A fixed 125-mg dose administered subcutaneously once a week after a single intravenous loading dose of approximately 10 mg/kg.
  40. 40. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (4) If the treatment target is not achieved (remission/low disease activity) with MTX + 1st generation anti TNF , go to 2nd generation Biological drugs. (ii)Rituximab (MABTHERA) (selective B cell depletion)
  41. 41. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy (4) If the treatment target is not achieved (remission/low disease activity) with MTX + 1st generation anti TNF , go to 2nd generation Biological drugs. (iii)Tocilizumab (ACTEMRA) (IL-6 inhibitor) 8mg/kg/month It has been proven to work with or without methotrexate.
  42. 42. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy In cases of refractory severe RA with contraindications to all biologic & synthetic DMARDs Try Azathioprine Cyclosporine A ( keep an eye on BP & renal profile) Or Cyclophosphamide (which is used in exceptional situations). A number of DMARDs has been excluded such as: D-Penicillamine, Minocycline, Auranofen because of its insufficient effect. Gold being effective drug, but limited availability & newer therapies resulted in less wide spread of the drug.
  43. 43. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If a patient with long standing (sustained) remission for 12 month ACR/EULAR 2011 Definition of Remission • At any time point, a patient must satisfy all of the following: • – Tender Joint Count ≤1 • – Swollen Joint Count ≤1 • – CRP ≤1 mg/dL • – Patient Global Assessment ≤1 (on a 0-10 scale)
  44. 44. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy If a patient with long standing (sustained) remission for 12 month • Tapper GCs at 1st. • Start to tapper biologic DMARDs (expand interval between the doses or reduce the dose). • But continue synthetic DMARDs in low dose because stoppage of synthetic DMARDs may lead to flare.
  45. 45. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Biological DMARDs characteristics • Provides rapid relief of signs & symptoms of RA • Onset of action within days or weeks. • Slowing or halting the progression of joint erosion. • Leads to remission in 2/3 of cases of RA; the remaining 1/3 shift to another biologic after 3-6 month.
  46. 46. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Biological DMARDs characteristics • Anti TNF are contraindicated during pregnancy and lactation.
  47. 47. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Biological DMARDs characteristics • Biologic DMARDs should be continued indefinitely or until side effects or therapeutic failure. • Ideally biologic DMARDs should be available to all patients who might benefit from them (the cost is the problem).
  48. 48. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Biologic DMARDs: Precautions & Contraindications: • Increase risk of bacterial infection: (septic arthritis, osteomyelitis, pyelonephritis, pneumonia, cellulitis) • Screening for active or latent TB with +ve purified protein derivative (PPD) test. • Indurated area <5mm is +ve in patients who are immunocompromised • Also ask for X-Ray chest, history of TB treatment. • CHF: in spite of increased TNF in heart failure. • Optic neuritis, demyelinating diseases. • Significant coronary artery disease.
  49. 49. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Biologic DMARDs: Precautions & Contraindications: • Not contraindicated in solid tumors if there is no recurrence in the past 5 years, however it should be avoided in lymphomas. • COPD • Viral infection HCV, HBV, HIV (reactivation of viral infection) • Temporarily suspended in patients undergoing surgery (one week before & one week after surgery). • Avoid vaccination with live attenuated vaccine (German measles, oral Polio, Rabies and Herpes Zoster) • Influenza vaccine & pneumococcal vaccine if required should be given 2-4 weeks prior to administration of biologic therapy.
  50. 50. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Comorbidities • Osteoporosis due to disease itself or GCs so add Ca & Vit D & ask for DEXA as follow up. • Cardiovascular disease: RA is a CV risk factor it is 60% higher just a year after diagnosis of RA. • It is the FIRST cause of death in RA. • Intensive treatment by MTX & anti TNF Biologic therapy reduce CV events by 70% (low dose aspirin, check for cholesterol level, HTN, DM, obesity, smoking or other risk factors). • Infection: is the SECOND most common cause of death. • COPD: RA patients are two times more likely to have COPD.
  51. 51. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Tofacitinib (Xelijanz) The U.S. Food and Drug Administration approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate. Nov. 6, 2012
  52. 52. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Tofacitinib (Xelijanz) It may be used as monotherapy or in combination with methotrexate or other non-biologic diseasemodifying antirheumatic drugs (DMARDs) (5 mg BID)  XELJANZ should not be used in combination with biologic DMARDs or potent immuno-suppressants such as azathioprine and cyclosporine.
  53. 53. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Tofacitinib (Xelijanz) In April 2013 the Committee for Medical Products was of the opinion that the benefits of Tofacitinib (Xeljanz) did not outweigh its risks and recommended authorization. that it be refused marketing
  54. 54. II-Recommendations for management of RA Medical Treatment of RA Prof. Fathy El-Belasy Tofacitinib (Xelijanz) These safety concerns include: • Serious infections. • certain cancers. • gastro-intestinal perforations. • liver damage. • and problems with increased lipid levels in the blood.
  55. 55. Conclusion There is a great need for a new more effective and less toxic drug which completely cure the disease. However, until a true cure is found, treatment of RA must be given on a long term basis to maintain clinical effectiveness.

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