Update of the CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF RHEUMATOID ARTHRITIS IN SPAIN Final, March 2007 1 Table of Contents I. METHODOLOGY .................................................................................................... 6 Preliminary phase: Structure of GUIPCAR_2007 and task assignment ...................................... 6 Review of the evidence ............................................................................................. 7 I.1.1. Summary .................................................................................................... 7 I.1.2. Review group of the Spanish Society of Rheumatology ............................................ 8 I.1.3. Systematic reviews ....................................................................................... 9 I.1.4. Application of the reviews .............................................................................. 17 Drafting the contents of GUIPCAR_2007 ......................................................................... 17 Editing GUIPCAR_2007 .............................................................................................. 18 II. BACKGROUND ..................................................................................................... 23 Importance of RA to the individual ............................................................................... 23 Importance of RA to society ....................................................................................... 23 III. DIAGNOSIS ......................................................................................................... 25 Suspected RA ......................................................................................................... 25 III.1.1. Importance of early diagnosis in RA.................................................................. 25 III.1.2. Detection of RA in Primary Care ...................................................................... 25 Access to the rheumatologist ...................................................................................... 27 III.1.3. Recent-onset arthritis units ........................................................................... 27 III.1.4. Organization of the consult in its interaction with primary care ............................... 28 Diagnosis of rheumatoid arthritis ................................................................................. 29 III.1.5. 1987 ACR classification criteria ....................................................................... 29 III.1.6. Diagnostic utility of biological tests in recent-onset RA ......................................... 32 III.1.7. Proposals of new diagnostic criteria for recent-onset arthritis ................................. 34 IV. EVALUATION ...................................................................................................... 37 Specific RA evaluation .............................................................................................. 37 IV.1.1. Appropriate data for first evaluation of RA patient ............................................... 37 IV.1.2. Data common to the initial evaluation and follow-up of RA .................................... 38 Treatment evaluation ............................................................................................... 54 IV.1.3. Objective of RA treatment ............................................................................ 54 IV.1.4. Treatment-response criteria .......................................................................... 54 IV.1.5. Frequency of check-ups ................................................................................ 56 IV.1.6. Nursing consultations ................................................................................... 57 RA comorbidity ....................................................................................................... 60 IV.1.7. RA complications ........................................................................................ 61 IV.1.8. Comorbidity not directly related with RA........................................................... 70 V. PHARMACOLOGICAL TREATMENT .............................................................................. 82 Pharmacological treatment of recent-onset rheumatoid arthritis. ......................................... 83 V.1.1. Disease-modifying anti-rheumatic drugs: dosage and commercial names ..................... 87 2 V.1.2. Evidence tables ........................................................................................... 90 Changes in treatment ............................................................................................... 103 Treatment with glucocorticoids ................................................................................... 107 Treatment with non-steroidal anti-inflammatories (NSAIDs) ................................................ 111 Treatment for pain .................................................................................................. 113 Treatment of RA in special situations ............................................................................ 114 V.1.3. Elderly patients........................................................................................... 114 V.1.4. Pregnancy and breastfeeding .......................................................................... 115 VI. SAFETY OF PHARMACOLOGICAL TREATMENT ............................................................... 119 Antimalarials: chloroquine (CLQ) and hydroxychloroquine (HCQ) .......................................... 119 Anti-TNFs: Infliximab (IFX), Etanercept (ETN), Adalimumab (ADA) ........................................ 120 VI.1.1. Adverse effects of the anti -TNFs .................................................................... 121 VI.1.2. Monitoring the anti-TNFs ............................................................................... 126 VI.1.3. Contraindications of the anti-TNFs................................................................... 127 Azathioprine (AZT) .................................................................................................. 127 VI.1.4. Adverse effects of azathioprine ...................................................................... 127 VI.1.5. Monitoring azathioprine ................................................................................ 128 Cyclophosphamide (CTX) ........................................................................................... 128 VI.1.6. Adverse effects of cyclophosphamide ............................................................... 129 Cyclosporin A (CSA) .................................................................................................. 131 VI.1.7. Adverse effects of cyclosporin A ..................................................................... 131 D-penicillamine (DPC) ............................................................................................... 132 VI.1.8. Adverse effects of D-penicillamine .................................................................. 132 Leflunomide (LEF) ................................................................................................... 133 VI.1.9. Adverse effects of leflunomide ....................................................................... 134 Methotrexate (MTX) ................................................................................................. 135 VI.1.10. Adverse effects of methotrexate ................................................................... 136 Gold salts: oral (AUR) and injectable (IG) ....................................................................... 138 VI.1.11. Adverse effects of gold salts ......................................................................... 139 Sulfasalazine (SSZ) ................................................................................................... 140 VI.1.12. Adverse reactions to sulfasalazine .................................................................. 140 Anakinra (ANK) ....................................................................................................... 142 VI.1.13. Adverse effects of anakinra .......................................................................... 142 Abatacept (ABT) ..................................................................................................... 143 VI.1.14. Adverse effects of abatacept ........................................................................ 143 VI.1.15. Contraindications ...................................................................................... 143 Rituximab (RTX) ...................................................................................................... 144 VI.1.16. Adverse effects of rituximab ........................................................................ 144 VI.1.17. Monitoring ............................................................................................... 145 VI.1.18. Contraindications ...................................................................................... 145 3 VII. OTHER TREATMENTS ........................................................................................... 151 Intra-articular treatment ........................................................................................... 151 VII.1.1. Indications ............................................................................................... 151 VII.1.2. Types of intra-articular treatment