Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The aim of this study was to systematically review the efficacy and safety of available drugs in patients with polymyositis (PM) or dermatomyositis (DM)
Methods: We systematically searched MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials up to October 2011 using a comprehensive search strategy for disease modifying drugs (DMARD), biologic therapies, intravenous immunoglobulins (IVIG), primary PMS and DPM, efficacy and safety (mesh terms and text words). Selection criteria were predefined by protocol. We selected meta-analysis, systematic literature reviews, clinical trials (CT), that included >18 year-old patients primary PMS and DM on the selected drugs, English, Spanish and French languages. Studies including patients with secondary PMS or DM, and basic science studies were excluded. Title and abstract selection and subsequent detailed review of selected articles were independently performed by two reviewers. A hand search of the selected articles was performed. The included studies quality was graded using the Oxford Levels of Evidence Scale, and results expressed as level of evidence (LE), recommendation grade (RG).
Results: The search strategy identified 2,442 potentially relevant articles, of which 114 were selected for full paper review. Twenty articles were eventually included in the analysis. The selection included 7 randomized CT, 13 open trials, which analyzed 334 patients. Main characteristics and results are shown in the table.
Conclusion: Rituximab is effective to achieve remission in patients with PM/DM refractory to standard therapy (high dose prednisone and DMARD), (LE 2b; GR B-C). There is no current evidence on the efficacy of infliximab in patients with PM/DM (LE 2b; GR B-C). The addition of etanercept to steroids does not increase response rate or decreased adverse events (LE 1c, GR B), but could be useful as steroids sparring in DM patients (LE 1c, GR B). The addition of azathioprine to steroids does not increase response rate or decreased adverse events in DM patients (LE 2b; GR B-C). IVIG are effective to achieve remission in patients with PM/DM refractory to DMARD (LE 2b, GR B-C).
Table 1. Main results of the systematic literature review.
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Study
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Efficacy
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Amato (2011), RCT (n=16 DM), 52 w, Oxford 1c ETA vs PCB
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– Improvement on IMACS: ETA/PCB 55%/60% – Prednisone stop: ETN/PCB 73%/20%, p<0,001 -Median time to treatment failure: ETA/PCB 358 d/148 d, p<0,001
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Bunch (1978), RCT (n=14 PM), 12 w, Oxford 2b AZA vs PCB
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-Muscle biopsy: AZA/PCB improvement, p>0,050 -MMT: improvement, AZA/PCB improvement, p>0,050 |
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Bunch (1980) RCT (n=16 PM), 12 w, Oxford 2b AZA vs PCB
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-CPK levels: AZA/PCB improvement, p>0,050 -Muscular strength AZA/PCB improvement, p=0,580 -Muscle biopsy: AZA/PCB improvement, p>0,050
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Dalakas (1993) RCT (n=15 DM), 24 w, Oxford 1c IVIG (1 infusion) vs PCB
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-Neuromuscular symptoms and scores of muscular strength: IG more improvement than PCB, p<0,018 p<0,035 -Muscle biopsy of IG patients: clear improvement |
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Fries (1973) RCT (n=8 PM), 16 w, Oxford 2b CYC vs PDN
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-Disease activity: CYC 5/5 worsened; PDN 3/3 improvement |
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Miyasaka (2011) RCT (n=26 PM/DM), 26 w, Oxford 1b IVIG vs PCB
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-MMT: IG/PCB improvement 92%/57%, p>0,050 –Dysphagia: IVIG ceased 5/7 (71%), PCB no improvement 2/2 (100%), p=0.167 -ADL score: IG/PCB improvement p>0,050 -CPK levels: IG/PCB improvement p>0,050
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Vencovsky (2000) RCT (n=36 PM/DM), 24 w, Oxford 1c MTX vs CyA
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-Muscle endurance and functional test: MTX/CyA improvement 29%/47%, p>0,050 -Clinical assessment: MTX/CyA improvement 65%/58%, p>0,050 -Global patient assessment: MTX/CyA improvement 59%/68%, p>0,050 -Muscle MRI: MTX/CyA improvement, p>0,050 -CPK levels: MTX normal levels, CyA elevated -ANA +: MTX/CyA 76%/ 68%, p>0,050
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Cherin (2002) OT (n=35 PM), 3 yr, Oxford 2b IVIG |
-Muscle power: improvement 25/35 (71%) -Muscle disability scale score: improvement 28/35 (80%) -Esophageal disorders: ceased 8/11 (27%) -Relapses: 7/25 (28%) -Steroids reduction: 22/35 (63%) -CPK levels: normal 19/33 (58%), improvement 14/33 (42%) |
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Cherin (1994) OT (n=11), 16 w, Oxford 2b IVIG |
-British Medical Council Research grading system: improvement 3/11 (27%) -CPK levels: reduction 8/11 (73%)
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Chung (2007) OT (n=8 DM), 24 w, Oxford 2b RTX |
-Partial remission: 3/8 (38%) -Muscle enzyme levels and skin scores: not significantly changed from those at baseline
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Dastmalchi (2008) OT (n=13 PM/DM), 16 w, Oxford 2b IFX |
-IMACS: improvement 3/9 (33%), worsened 3/9 (33%) -MMT: no improvements -Muscle MRI: worsened 5 patients -Muscle biopsy: no changes from baseline |
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García Hernán. (2010), OT (n=14 PM/DM), 1 yr, Oxford 2b RTX + CYC |
–Comlete or partial remission 1 m/6 m/1yr: 65%/100%/64% -British Medical Research Council grading system: improvement 100% -5 relapses, median of time to relapse: 11 m -Significant decreased: EGS, CPK, Mb, LDH –Pulmonary function: improvement 75%
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Hara (2003) OT (n=11), 12 w, Oxford 2b IVIG |
-MMT: improvement 7/8 (88%) -ADL score: improvement 7/8 (88%) -CPK levels: improvement 7/8 (88%)
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Hengstman (2008) OT (n=6 PM/DM), 26 w, Oxford 2b IFX + MTX |
-Patient and physician disease activity assessment, MMT, handheld dynamometry: improved -CPK levels: improved 2/6 (33%) |
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Kameda (2005) OT (n=10 DM + interstitial pneumonia), Oxford 2b Prednisolone + CYC + CyA
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– 5 survived for > 2 yr well
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Levine (2005) OT (n=7 DM), 52 w, Oxford 2b RTX |
-MMT: improvement 6/7 (86%) -Rash, alopecia, and reduced forced vital capacity, improved markedly -4 relapses
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Mastaglia (1998) OT (n=7 PM/DM), Oxford 2b IVIG |
-Complete or partial remission: 5/7 (71%) –Fuerza muscular: improvement 5/7 (71%) -CPK levels: normalization 5/7 (71%) |
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Mok (2007) OT (n=4 PM), 28 w, Oxford 2b RTX
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–Promimal muscle power scores: improved 100% -CPK levels: improvement 100%, 2 normalization -HAQ: improvement 100% -Disability scores, SF-36: trend to improvement |
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Saito (2008) OT (n=15 PM/DM), 12 w, Oxford IGIV |
-MMT: improvement 14/15 (93%) -ADL score: improvement 12/15 (80%) -CPK levels: improvement 15/15 (100%) |
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Tokano (2002) OT (n=11 DM/PM), 24 w, Oxford 2b CyA |
-Respiratory sympthoms improveement, ↑ PaO2>10 mmHg, ↑ %DLCO, improvement chest radiology/TACAR, ↓steroids doses >10%, ↓ LDH>25%: 7/11 (64%) maintained improvement
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Abbreviations: PM=polymyositis; DM=dermtomyositis: w=week; m=month; yr=year; ETA=etanercept; PCB=placebo; AZA= azathioprine; CPK=creatine phosphokinase; CYC=cyclophosphamide; PDN=prednisone; CyA= cyclosporine A; MTX= methotrexate; IVIG=intravenous immunoglobulins; RTX=rituximab; IFX=infliximab; MMT=Manual muscle tests; ADL= activities of daily living; EGS= erythrocyte globular sedimentation; LDH= L-lactate dehydrogenase; IMACS=International Myositis Assessmenet Clinical Studies; HAQ=health assessment questionnaire.
Disclosure:
J. Martinez-Lopez Sr.,
None;
J. Graña Sr.,
None;
S. Muñoz-Fernandez,
None;
I. Rua-Figueroa,
None;
J. M. Pego-Reigosa,
None;
E. Loza Sr.,
None;
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