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10.1.3 Drugs which suppress the rheumatic disease process (DMARDs)

10.1.3 Drugs which suppress the rheumatic disease process (DMARDs)
These are sometimes called disease modifying anti-rheumatic drugs (DMARDs). They are used when NSAIDs alone are not sufficient
and they should only be initiated by a specialist. They require 4-6 months of treatment for a full response. If there is no benefit 
after 6 months they should be discontinued on specialist advice. 

AMBER SHARED CARE    Azathioprine tablets 25mg, 50mg  
AMBER SHARED CARE     Ciclosporin (Neoral®) 
                                            capsules 25mg, 100mg
                                            oral solution 100mg/mL
RED                                     Cyclophosphamide injection 500mg, 1g 
AMBER                               Hydroxychloroquine tablets 200mg - seePrescriber Information Sheet
AMBER SHARED CARE     Leflunomide tablets 10mg, 20mg 
RED                                     Leflunomide tablets 100mg (used for initial loading doses only)
 
Secondary care will prescribe and supply leflunomide for the first three months, the primary care prescriber may then take over 
prescribing and the associated monitoring.
 
Methotrexate  
All new patients started on methotrexate will be supplied with 2.5mg tablets only.  Prescribers are reminded to follow the 
monitoring guidance outlined in the shared care protocol available here.
 
AMBER SHARED CARE    Methotrexate tablets 2.5mg only 
RED                                    Methotrexate injection, for s/c or i/m use (Metoject®, Ebetrex®) 
 
Methotrexate should be prescribed once weekly as a single dose on the same day each week. 
Folic acid 5mg should normally be taken the day after methotrexate dosing. 
AMBER SHARED CARE     Penicillamine tablets 125mg, 250mg 
AMBER SHARED CARE     Sodium aurothiomalate injection 10mg, 20mg, 50mg 
AMBER SHARED CARE     Sulfasalazine tablets e/c 500mg 
 

Cytokine modulators 
 
These drugs should be prescribed by specialists only, and in line with any relevant NICE guidance. 
Certolizumab, rituximab and tocilizumab (inc. Abatacept, Adalimumab, Etanercept, Golimumab and Infliximab) - NICE
guidance for rheumatoid arthritis (TAG 130, 186, 195, 198, & 225).     
 
Treatment pathways for highly active rheumatoid arthritis in adults who have failed to respond to at least two standard disease
modifying anti-rheumatic drugs (DMARDs) including methotrexate. These drugs should be prescribed according to the guidelines 
of the British Society for Rheumatology under the supervision of consultant rheumatologist.   Please refer to the full guidelines for
further information.
 
 
                  
Secukinumab is recommended, within its marketing authorisation, as an option for treating active ankylosing spondylitis in 
adults whose disease has responded inadequately to conventional therapy (non-steroidal anti-inflammatory drugs or TNF‑alpha
inhibitors) as per NICE TA407 
RED       Secukinumab solution for injection 150mg/1mL
 
NICE TA719  CCG Commissioned
Secukinumab is recommended as an option for treating active non-radiographic axcial sponyloarthritis with objective signs of
inflammation that is not well controlled enough with NSAIDs in adults. It is recommended only if:
       > tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and
       > the company provides secukinumab according to the commercial arrangement.
 RED     Secukinumab solution for injection [Cosentyx]
 
NICE TA718 CCG Commissioned
Ixekizumab is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough with 
conventional therapy, or active non-radiographic axial spondyloarthritis with objective signs of inflammation (shown by 
elevated C-reactive protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs), in 
adults. It is recommended only if:
   > tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and 
   > the company provides ixekizumab according to the commercial arrangement.
 
 NICE TA829 NHS England Commissioned
 Upadactinib is recommended as an option for treating active ankylosing spondylitis that is not controlled well enough
 with conventional therapy in adults, only if:
   > tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and
   > the company provides upadacitinib according to the commercial arrangement.
 See full guidance for further information
 RED    Upadactinib modified release tablets 15mg, 30mg (Rinvoq)
 
NICE TA861 ICB Commissioned, Blueteq required
Upadactinib is recommended as an option for treating active non-radiographic axial spondyloarthritis with objective signs of inflammation  (shown by elevated C-reactive
protein or MRI) that is not controlled well enough with non-steroidal anti-inflammatory drugs (NSAIDs) in adults. It is recommended only if:
   > tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough and
   > the company provides upadacitinib according to the commercial arrangement.
 
NICE TA715 NHS England Commissioned
Adalimumab, etanercept and infliximab, all with methotrexate, are recommended as options for treating active rheumatoid arthritis in adults, only if:
  > intensive therapy with 2 or more conventional disease-modifying antirheumatic drugs (DMARDs) has not controlled the disease 
     well enough and
  > disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and
  > the companies provide adalimumab, etanercept and infliximab at the same or lower prices than those agreed with the 
     Commercial Medicines Unit.
 
RED     Adalimumab solution for injection
RED     Etanercept solution for injection
RED     Infliximab powder for concentrate for solution for injection
RED     Abatacept
 
 
Adalimumab, Certolizumab pegol , Etanercept, Golimumab and Infliximab - in line with NICE Guidance for Ankylosing spondylitis 
and non-radiographic axial spondyloarthritis (TA 383)   
(Replaces NICE technology appraisal guidance on adalimumab, etanercept and infliximab for ankylosing spondylitis (TA143) and 
golimumab for the treatment of ankylosing spondylitis (TA233).  
 
These drugs are for people with severe active ankylosing spondylitis or severe non-radiographic axial spondyloarthritis who have 
tried non‑steroidal  anti‑inflammatory, drugs (NSAIDs), but they have not worked.
 
RED           Adalimumab pre-filled pen/syringe 40mg 
RED           Certolizumab pegol pre-filled syringe 200mg
RED           Etanercept vial for injection 25mg  
                   pre-filled pen/syringe 25mg, 50mg   
RED           Golimumab pre-filled pen/syringe 50mg,100mg 
RED           Infliximab vial for infusion 100mg 
 
Golimumab for severe non-radiographic axial spondyloarthritis.  
This drug is for adults who have tried non-steroidal anti-inflammatory  drugs (NSAIDs), but they have not worked. 
Recommended as an option, within its marketing authorisation, as an option in NICE TA497
 
RED        Golimumab 50 mg solution for injection in pre-filled pen (Simponi®)                          CCG Commissioned - BlueTeq Form 
 
Adalimumab, Etanercept, Infliximab, Certolizumab pegol, Golimumab, tocilizumab and abatacept.
NICE Guidance for Rheumatoid arthritis not previously treated with DMARDS or after conventional DMARDS only have
failed are recommended as an option by NICE. NICE TA375.   Please refer to full guidelines for further information. 
 
Belimumab NICE TA752 -updates and replaces NICE TA397 
Recommended as an option as add-on treatment for active autoantibody-positive systemic lupus erythematosus in people with
high disease activity despite standard treatment, only if:
    > high disease activity is defined as at least 1 serological biomarker (positive abti-double0strabded DNA or low complement)
       and a SELENA-SLEDAI score of greater than or equal to 10
    > treatment is continued beyond 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more
    > the company [provides belimumab according to the commercial arrangement.
 
RED     Belimumab ( Benlysta®) 
            powder for concentrate for solution for infusion 120mg, 400mg                                        NHS England Commissioned
 
Adalimumab, Etanercept, Golimumab and Infliximab - NICE guidance for psoriatic arthritis (NICE TAG199 & 220) 
Treatment options for adults with severe active psoriatic arthritis who:  
       >     have peripheral arthritis with three or more tender joints, and
       >     three or more swollen joints, and 
       >     other disease modifying anti-rheumatic drugs (DMARDs) administered individually or in combination have not worked.
            
 Please refer to the full guidelines for further information. 
 
RED Risankizumab NICE TA803 [Active psoriatic arthritis] 
NICE TA803    Risankizumab, alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis in
                       adults whose disease has not responded well enough to DMARDs or who cannot tolerate them. 
                       It is recommended only if they have:
                           > peripheral arthritis with 3 or more tender joints and 3 or more swollen joints
                           > moderate to severe psoriasis [a body surface area of at least 3% affected by plaque psoriasis and a Psoriasis
                              Area and Severity Index [PASI] score greater than 10
                           > had 2 or more conventional DMARDS and at least 1 biological DMARD
                        Risankizumab is only recommended if the company provides it according to the commercial arrangement. 
                        See full guidance recommendations                                                                                ICB Commissioned, Blueteq required
Tofactiinib for treating polyarticular juvenile idiopathic arthritis                                                   NHS England Commissioned
NICE TA735   Tofacitinib is recommended as an option for treating active polyarticular juvenile idiopathic arthritis (JIA; rheumatoid  
                       factor positive or negative polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis in people 2 years 
                       and older. This is if their condition has responded inadequately to previous treatment with disease-modifying 
                       antirheumatic drugs (DMARDs),and only if:
                            >   a tumour necrosis factor (TNF)‑alpha inhibitor is not suitable or does not control the condition well enough, and
                            >   the company provides tofacitinib according to the commercial arrangement.
 
Abatacept (Orencia), adalimumab (Humira), etanercept (Enbrel) and tocilizumab (RoActemra) are recommended as possible
treatments for people with polyarticular juvenile idiopathic arthritis. Full guidance - NICE TA373 [replaces NICE TA35}
 
          > Adalimumab and etanercept are recommended as possible treatments for people with enthesitis-related juvenile 
             idiopathic arthritis.
          > Etanercept is recommended as a possible treatment for people with psoriatic juvenile idiopathic arthritis 
 
Abatacept
Abatacept may be considered as a second line option for rheumatoid arthritis if either rituximab or methotrexate is 
contraindicated or an adverse reaction has been experienced.
(see NICE guidance). Infusion to be administered in hospital. (NICE TA195)
 
Abatacept for treating Rheumatoid Arthritis after failure of conventional disease modifying anti-rheumatic drugs (NICE TAG280)
(rapid review of TAG234) - recommended as an option by NICE in adults whose disease has responded inadequately to two
conventional DMARD's including methotrexate if used in accordance with recommendations for other biologicals (TAG130) and 
PAS is provided.
RED           Abatacept vial for infusion 250mg
RED           Abatacept pre-filled pen/syringe 125mcg
 
Adult onset Still's disease and systemic juvenile idiopathic arthritis
RED  Anakinra (Kineret® 100mg/0.67ml solution for injection pfs)                                                                  NHS England Commissioned
NICE TA685  Recommended as an option for treating Still's disease with moderate to high disease activity, or continued disease
                      activity after non-steroidal anti-inflammatory drugs [NSAIDs] or glucocorticoids. It is only recommended for:
                           > adult onset Still's disease that has responded inadequately to 2 or more conventional disease-modifying
                              antirheumatic drugs [DMARDs]
                           > systemic juvenile idiopathic arthritis in people 8 months and older with a body weight of 10kg or more that has 
                              not responded to at least 1 conventional DMARD
 See full guidance for further information                                                                                                     
Adalimumab 
Adalimumab is recommended either alone or in combination for the treatment of psoriatic arthritis and ankylosing spondylitis. 
It is also a treatment option for rheumatoid arthritis  (see NICE guidance). Patients should be trained to self administer the 
injection.
 
RED           Adalimumab pre-filled pen/syringe 40mg
 
Apremilast - NICE TA433 (relaces TA372)                                                                                                            CCG Commissioned
Apremilast, alone or in combination with disease-modifying antirheumatic drugs (DMARDs), is recommended as an option for 
treating active psoriatic arthritis in adults only if:
 
          ¤     they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and
          ¤     their disease has not responded to adequate trials of at least 2 standard DMARDs, given either alone or in 
                 combination and
          ¤     the company provides apremilast with the discount agreed in the patient access scheme
 
RED        Apremilast tablets 10mg, 20mg, 30mg (Otezla®)
 
Certolizumab  
Certolizumab pegol in combination with methotrexate is indicated for the treatment of moderate to severe, active rheumatoid 
arthritis in adult patients when the response to conventional disease modifying anti-rheumatic drugs (DMARDs)  including 
methotrexate, has been inadequate (see NICE guidance). Patients should be trained to self administer the injection.
 
RED           Certolizumab pre-filled syringe 200mg
 
Certolizumab Pegol   and Secukinumab as per NICE TA445                                                                                       CCG Commissioned 
option for treating active psoriatic arthritis after inadequate response to DMARDS in adults only if:
  •  it is used as described in the NICE technology appraisal guidance on on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis  (recommendations 1.1 and 1.2) or 
  • the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease has stopped responding after the first 12 weeks.
    Certolizumab pegol is only recommended if the company provides it as agreed in the patient access
See Psoriatic Arthritis Recommended Treatment Pathway
 
Active Rheumatoid Arthritis
RED    Filgotinib [Jyseleca® tablets 100mg, 200mg]
NICE TA676   Filgotinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose
                       disease has responded inadequately to intensive therapy with 2 or more conventional disease-modifying 
                       antirheumatic drugs (DMARDs). See full guidance for further information.  (CCG Commissioned, BlueTec form required)
 
Ixekizumab NICE TA537 alone, or with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults, 
only if:
      •     it  is used as described in NICE's technology appraisal guidance on entanercept, infliximab and adalimumab for the
              treatment of psoriatic arthritis (recommendations 1.1 and 1.2) or 
      •      the person has had a tumour necrosis factor (TNF) -alpha inhibitor but their disease has not responded within the first
             12 weeks or has stopped responding after the first 12 weeks or
      •      TNF‑alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE technology appraisal 
              guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).
              Ixekizumab is only recommended if the company provides it according to the commercial arrangement.
 
Secukinumab alone, or in combination with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults only if:

RED            Secukinumab pre-filled syringe 150mg/1mL

Certolizumab active and progressive psoriatic  arthritis NICE TA199
Certolizumab is recommended for the treatment of adults with active and progressive psoriatic  arthritis in line withNICE TA199, that is when the person has peripheral arthritis with three or more tender joints and three or more swollen joints and their psoriatic
arthritis has not responded to adequate trials of at least two standard disease-modifying antirheumatic drugs, administered 
either individually or in combination. Certolizumab should be used in combination with methotrexate where possible, however 
can be given as monotherapy in the case of intolerance to methotrexate or when continued treatment with methotrexate is 
inappropriate
 
RED            Certolizumab pre-filled syringe 200mg
 
Certolizumab - (2nd line option in psoriatic arthritis)
An option as  as a second line anti-TNF (tumour necrosis factor) in psoriatic arthritis (PsA) following discontinuation of first anti- 
TNF following discontinuation of first anti-TNF due to an adverse event or primary or secondary inefficacy.
 
RED             Certolizumab pre-filled syringe 200mg
 
Certolizumab -  severe active ankylosing spondylitis NICE TA143 
Certolizumab pegol is licensed for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate
response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs)  (in line with NICE TA143) 
RED            Certolizumab pre-filled syringe 200mg
 
Certolizumab - rheumatoid arthritis as per NICE TA415
Certolizumab pegol  is recommended as an option for treating rheumatoid arthritis after inadequate response to a
TNF-alpha inhibitor -  NICE TA415
RED            Certolizumab pre-filled syringe 200mg                                                                                                 (CCG commissioned ) 
 
Etanercept 
Etanercept is recommended either alone or in combination with methotrexate for the treatment of active polyarticular juvenile 
idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis. It is also a treatment option for rheumatoid arthritis
(see NICE guidance). Patients should be trained to self administer the injection.
RED           Etanercept vial for injection 25mg
                   pre-filled pen/syringe 25mg, 50mg
 
Baricitinib
Baricitinib, recommended as an option for treating active rheumatoid arthritis in adults as per NICE guidance TA466
 
Golimumab  
Treatment option for adults with severe active psoriatic arthritis only if used as described for other tumour necrosis factor (TNF)
inhibitors and the manufacturer provides the 100mg dose of Golimumab at the same cost as the 50mg dose. 
Please refer to the full guidelines for further information.
RED         Golimumab pre-filled pen/syringe 50mg,100mg  
 
Guselkumab NICE TA815 (updates and replaces NICE TA711)
Guselkumab, alone with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. 
It is recommended only if they have had 2 conventional DMARDs and:
          > have had at least 1 biological DMARD, or
          > tumour necrosis factor (TNF)-alpha inhibitors are contraindicated but would otherwise be considered (as described in
             NICE's technology appraisal guidance on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis).
Guselkumab is recommended only if the company provides it according to the commercial arrangement.
Active psoriatic arthritis is defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints.
RED         Guselkumab solution for injection pre-filled pens 100mg/mL [Tremfya]
   See Full guidance                                                                                                                                ICB Commisisoned Blueteq Form Required
 
Infliximab     
Infliximab may be considered as an option to treat rheumatoid arthritis where:
          > Certolizumab, adalimumab and etanercept are contraindicated, or
          > Methotrexate is contraindicated or not tolerated, or
          > the patient cannot self inject (see NICE guidance). 
It is also a treatment option for psoriatic arthritis. Infusion to be administered in hospital.
RED           Infliximab vial for infusion 100mg
 
Rituximab 
Rituximab in combination with methotrexate is recommended as a second line option for the treatment of adults with severe
active rheumatoid arthritis who have had an inadequate response to, or are intolerant of, other disease modifying
anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF) inhibitor. Treatment with rituximab should
be given no more frequently than every 6 months (see NICE guidance). Infusion to be administered in hospital.
Pre-medication 30-60 minutes before hand with methylprednisolone is necessary to reduce infusion-related reactions. Rituximab 
should be prepared by a pharmacist or healthcare professional observing aseptic techniques. As per BSR guidelines for anti-TNFs,
treatment should be withdrawn following adverse events or where there is an inadequate response at 3 months following 
initiation of treatment. Rituximab should be funded via 'pass through funding' under payment by results, booked out to individual 
patients in pharmacy and recharged directly to the PCTs. 
RED           Rituximab vial for infusion 100mg, 500mg     
 
Sarilumab - NICE guidance for moderate to severe rheumatoid arthritis (TA485)
Sarilumab with methotrexate , is recommended as an option for treating active rheumatoid arthritis in adults whose disease
has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs 
(DMARDs) - as per NICE TA485
                                                                                                                                            CCG Commissioned (Blue Tec form required)        
 
Tocilizumab   
Tocilizumab in combination with methotrexate is recommended third line for the treatment of moderate to severe active 
rheumatoid arthritis in people whose condition (NICE TA198):
          > has responded inadequately to one or more tumour necrosis factor alpha (TNFα) inhibitors; and 
          > has responded inadequately or are contraindicated to rituximab, or when rituximab is withdrawn because of an adverse
             effect as per NICE guidance. 
Tocilizumab in combination with methotrexate is recommended for some children with juvenile idiopathic arthritis where all other
treatments have failed (NICE TA238). Infusion to be administered in hospital.
RED           Tocilizumab vial for infusion 80mg, 200mg, 400mg
 
Subcutaneous Tocilizumab is recommended for use as an alternative to intravenous Tocilizumab providing the patient meets the
prescribing criteria as set out in NICE technology appraisals for 1st, 2nd and 3rd  line use to treat active rheumatoid arthritis (RA)
and the agreed Lancashire  Rheumatology Alliance flex for use as monotherapy. CLICK here to link to the recommendation.
RED      Tocilizumab injection 162mg pre-filled syringe   
Tocilizumab is recommended as an option in treating Giant Cell Arteritis by NICE TA518, when used with a tapering course of 
glucocoticoids (and when used alone after glucocorticoids) only if:
          > they have relapsing or refractory disease
          > they have not already had
          > tocilizumab is stopped after 1 year of uninterrupted treatment at most and
          > the company provides it with the discount agreed in the patient access scheme
RED         Tocilizumab concentration for solution for infusion (RoActemra®)                                          (NHS England Commissioned)
 
 
Tofacitinib - Moderate to severe rheumatoid arthritis NICE TA480 
Tofacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has 
responded inadequately to intensive therapy with a combination of conventional disease-modifying anti-rheumatic drugs 
(DMARDs), only if:
        > disease is severe (a disease activity score [DAS28] of more than 5.1) and
        >  the company provides tofacitinib with the discoiunt agreed in the patient access scheme
 
Tofacitinib with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults whose disease has 
responded inadequately to, or who cannot have, other DMARDs, including at least 1 biological DMARD, only if:
       >  disease  is severe (a DAS28 of more than 5.1) and
       >  they cannot have rituximab
       >  the company provides tofacitinib with the discount agreed in the patient access scheme
 
Tofacitinib can be used as monotherapy for adults who cannot take methotrexate because it is contraindicated or because of 
intolerance, when the criteria in sections 1.1 and 1.2 are met.
RED       Tofacitinib 
               tablets 5mg (Xeljanz®)                                                                                          (CCG Commissioned - Blue Teq form required)
 
 

Tofacitinib -Active psoriatic arthritis after inadequate response to DMARDs NICE TA543

Tofacitinib, with methotrexate, is recommended as an option for treating active psoriatic arthritis in adults only if:
          >    only if it is used as described in NICE's technology appraisal guidance on entanercept, infliximab and adalimumab for the 
                treatment of psoriatic arthritis (recommendations 1.1 and 1.2) or
          >    the person has had a tumour necrosis factor (TNF)-alpha inhibitor but their disease had not responded within the first 
                12 weeks or has stopped responding after 12 weeks or
          >    TNF-alpha inhibitors are contraindicated but would otherwise be considered (as described in NICE's technology appraisal 
                on etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis)
 
 Tofacitinib is only recommended if the company provides it according to the commercial arrangement.
 
 RED       Tofacitinib                                                                                                                 (CCG Commissioned - BlueTeq form required)
                tablets 5mg, 10mg (Xeljanz®)  
 
 
RED    Upadacitinib [Rinvoq]
NICE TA665  Upadacitinib is recommended as an option for treating severe rheumatoid arthritis in adults.
                      See full guidance for recommendations.
                                                                                                                                                   (CCG Commissioned - BlueTeq form required)
 
RED     Upadacitinib [Rinvoq]
NICE TA744   Upadacitinib, with methotrexate, is recommended as an option for treating active rheumatoid arthritis in adults
                       whose disease has responded inadequately to intensive therapy with 2 or more conventional disease‑modifying 
                       antirheumatic drugs (DMARDs), only if:
                            > disease is moderate (a disease activity score [DAS28] of 3.2 to 5.1) and
                            > the company provides upadacitinib according to the commercial arrangement.
                                                                                                                                             (CCG Commissioned - BlueTeq form required)