Ofatumumab for the treatment of chronic lymphocytic leukaemia refractory to fludarabine and alemtuzumab (TA202)

Technology Appraisal Guidance No. 202

Source: National Institute for Health and Care Excellence

1 Guidance
1.1 Ofatumumab is not recommended for the treatment of chronic lymphocytic leukaemia that is refractory to fludarabine and alemtuzumab.

1.2 People currently receiving ofatumumab for the treatment of chronic lymphocytic leukaemia that is refractory to fludarabine and alemtuzumab should have the option to continue treatment until they and their clinician consider it appropriate to stop.


The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA202

An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N2334. It is also available on the Internet at http://guidance.nice.org.uk/TA202/QuickRefGuide/pdf/English

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Ofatumumab for the treatment of chronic lymphocytic leukaemia refractory to fludarabine and alemtuzumab
Issue Date: October 2010
Review Date: September 2013

1                                Guidance

1.1                           Etanercept, infliximab and adalimumab are recommended for the treatment of adults with active and progressive psoriatic arthritis when the following criteria are met.

·              The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and

·              The psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying antirheumatic drugs (DMARDs), administered either individually or in combination.

1    Guidance
1.1    Etanercept, infliximab and adalimumab are recommended for the treatment of adults with active and progressive psoriatic arthritis when the following criteria are met.
•    The person has peripheral arthritis with three or more tender joints and three or more swollen joints, and
•    The psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying antirheumatic drugs (DMARDs), administered either individually or in combination.
1.2    Treatment as described in 1.1 should normally be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules.
1.3    Etanercept, adalimumab or infliximab treatment should be discontinued in people whose psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks. An adequate response is defined as an improvement in at least two of the four PsARC criteria, (one of which has to be joint tenderness or swelling score) with no worsening in any of the four criteria. People whose disease has a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks but whose PsARC response does not justify continuation of treatment should be assessed by a dermatologist to determine whether continuing treatment is appropriate on the basis of skin response (see ‘Etanercept and efalizumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 103], ‘Infliximab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 134] and ‘Adalimumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 146] for guidance on the use of tumour necrosis factor [TNF] inhibitors in psoriasis).
1.4    When using the PsARC healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to components of the PsARC and make any adjustments they consider appropriate.

1.2                           Treatment as described in 1.1 should normally be started with the least expensive drug (taking into account drug administration costs, required dose and product price per dose). This may need to be varied for individual patients because of differences in the method of administration and treatment schedules. 

1.3                           Etanercept, adalimumab or infliximab treatment should be discontinued in people whose psoriatic arthritis has not shown an adequate response using the Psoriatic Arthritis Response Criteria (PsARC) at 12 weeks. An adequate response is defined as an improvement in at least two of the four PsARC criteria, (one of which has to be joint tenderness or swelling score) with no worsening in any of the four criteria. People whose disease has a Psoriasis Area and Severity Index (PASI) 75 response at 12 weeks but whose PsARC response does not justify continuation of treatment should be assessed by a dermatologist to determine whether continuing treatment is appropriate on the basis of skin response (see ‘Etanercept and efalizumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 103], ‘Infliximab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 134] and ‘Adalimumab for the treatment of adults with psoriasis’ [NICE technology appraisal guidance 146] for guidance on the use of tumour necrosis factor [TNF] inhibitors in psoriasis).

1.4                           When using the PsARC healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person’s responses to components of the PsARC and make any adjustments they consider appropriate.


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