Table 3.
Managing patients with evidence of disease activity while being treated with cladribine tablets.
| Consensus recommendations | Strength of recommendation‡ | Level of consensus¶ |
|---|---|---|
| Q3a. How would you manage a patient who has taken the first course of cladribine tablets but has evidence of new disease activity in year 1? (Level of evidence: moderate) | ||
| After the first treatment course of cladribine tablets in year 1, a patient with disease activity less than pre-treatment levels, might not necessarily be an indication for treatment discontinuation.*19,29 | 8 (8.3) | 97.0% (32/33) |
| Corticosteroids should be used to treat the relapse according to local guidelines. Clinicians may wait and monitor the patient and provide cladribine tablets at the beginning of year 2 in order to allow the patient to receive the recommended cumulative dose. | 9 (8.4) | 97.0% (32/33) |
| *Disease activity in the first 3–6 months of treatment with cladribine tablets may be a carry-over from a patient’s prior treatment, especially for those switching from lymphocyte trafficking agents (fingolimod or natalizumab). | ||
| Q3b. How would you manage a patient who has worsening disease activity during the first two years of treatment with cladribine tablets? (Level of evidence: very low) | ||
| During the first two years of treatment with cladribine tablets, a patient with increasing disease activity above pre-treatment levels, may be a candidate for a treatment switch to another high-efficacy DMD.* | 8 (8.0) | 87.9% (29/33) |
| Corticosteroids should be used to treat relapses according to local guidelines. | 9 (8.7) | 97.0% (32/33) |
| *Disease activity in the first 3–6 months of treatment with cladribine tablets may be a carry-over from a patient’s prior treatment, especially for those switching from lymphocyte trafficking agents (fingolimod or natalizumab). • Refer to Question 1b for the threshold of clinical or radiological activity in a patient following an appropriate course of a DMD that indicates a suboptimal responder • Refer to Question 10 for ‘How to switch from cladribine tablets’. | ||
| Q4a. How would you manage a patient who has taken the indicated two courses of cladribine tablets but has evidence of new/reappearing disease activity only in year 3–4? (Level of evidence: low) | ||
| Clinicians should consider a switch to another high-efficacy DMD in a patient with a complete but non-durable response to cladribine tablets with evidence of new/reappearing disease activity in year 3–4 | 7 (6.7) | 60.6% NOT ACHIEVED |
| Clinicians should consider treatment options and associated risks and discuss with the patient. | 9 (8.6) | 100% (33/33) |
| • Refer to Question 1b for the threshold of clinical or radiological activity in a patient following an appropriate course of a DMD that indicates a suboptimal responder • Refer to Question 10 for ‘How to switch from cladribine tablets’ | ||
| Q4b. How would you manage a patient who has taken the indicated two courses of cladribine tablets but has evidence of new/reappearing disease activity only beyond year 4? (Level of evidence: low) | ||
| Treatment options for a patient with a complete but non-durable response to cladribine tablets with evidence of new/reappearing disease activity beyond year 4 could include: • Consideration of a switch to another high-efficacy DMD after thorough risk/benefit analysis. • Consideration of re-initiation with cladribine tablets, after thorough risk/benefit analysis. • Benefit of additional treatment with cladribine tablets in response to disease activity beyond year 2 has not been investigated. The incidence of lymphopenia and other adverse events is increased with additional treatment in years 3 or 4. Re-initiation of therapy after year 4 has also not been investigated. • Clinicians should consider treatment options and associated risks and discuss with the patient. |
8 (8.3) | 97.0% (32/33) |
‡
Median score on a 1–9 scale (mean score in brackets).
¶
Percentage of votes with 7–9 on a 9-point scale.
DMD, disease modifying drug.